what will taking half a bottle of.ibuprofen do to you

BOXED Warning

Cardiovascular Thrombotic Events

  • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can exist fatal. This take a chance may occur early in handling and may increment with duration of use (encounterWARNINGS andPRECAUTIONS).
  • Ibuprofen tablets are contraindicated in the setting of coronary artery featherbed graft (CABG) surgery (meetCONTRAINDICATIONS andWARNINGS).

 Gastrointestinal Risk

  • NSAIDS cause an increased chance of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which tin exist fatal. These events tin can occur at whatever time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events (come acrossWARNINGS).

DESCRIPTION

Ibuprofen tablets contain the active ingredient ibuprofen, which is (±) - 2 - (p - isobutylphenyl) propionic acrid. Ibuprofen is a white powder with a melting point of 74-77° C and is very slightly soluble in water (< 1 mg/mL) and readily soluble in organic solvents such equally ethanol and acetone .
The structural formula is represented below:

Ibu image

Ibuprofen tablets, a nonsteroidal anti-inflammatory drug ( NSAID ), are available in 400 mg, 600 mg, and 800 mg tablets for oral administration. Inactive ingredients:  silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycols, polyvinyl booze, pregelatinized starch, talc and titanium dioxide.

CLINICAL PHARMACOLOGY

Ibuprofen tablets comprise ibuprofen which possesses analgesic and antipyretic activities. Its mode of activity, like that of other NSAIDs, is not completely understood, but may be related to prostaglandin synthetase inhibition.

In clinical studies in patients with rheumatoid arthritis and osteoarthritis, ibuprofen tablets take been shown to exist comparable to aspirin in decision-making pain and inflammation and to be associated with a statistically significant reduction in the milder gastrointestinal side furnishings (run into Adverse REACTIONS). Ibuprofen tablets may be well tolerated in some patients who accept had gastrointestinal side effects with aspirin, but these patients when treated with ibuprofen tablets should be carefully followed for signs and symptoms of gastrointestinal ulceration and bleeding. Although it is not definitely known whether ibuprofen tablets causes less peptic ulceration than aspirin, in one study involving 885 patients with rheumatoid arthritis treated for upwardly to one yr, at that place were no reports of gastric ulceration with ibuprofen tablets whereas frank ulceration was reported in 13 patients in the aspirin group (statistically significant p< .001).

Gastroscopic studies at varying doses prove an increased tendency toward gastric irritation at higher doses. Nevertheless, at comparable doses, gastric irritation is approximately half that seen with aspirin. Studies using 51Cr-tagged red cells point that fecalblood loss associated with ibuprofen tablets in doses up to 2400 mg daily did non exceed the normal range, and was significantly less than that seen in aspirin-treated patients.

In clinical studies in patients with rheumatoid arthritis, ibuprofen tablets have been shown to be comparable to indomethacin in decision-making the signs and symptoms of disease activity and to exist associated with a statistically meaning reduction of the milder gastrointestinal (encounterAdverse REACTIONS  ) and CNS side furnishings.

Ibuprofen tablets may be used in combination with gold salts and/or corticosteroids.

Controlled studies have demonstrated that ibuprofen tablets are a more constructive analgesic than propoxyphene for the relief of episiotomy pain, hurting following dental extraction procedures, and for the relief of the symptoms of primary dysmenorrhea.

In patients with primary dysmenorrhea, ibuprofen tablets take been shown to reduce elevated levels of prostaglandin activity in the menstrual fluid and to reduce resting and agile intrauterine force per unit area, as well as the frequency of uterine contractions. The probable mechanism of action is to inhibit prostaglandin synthesis rather than simply to provide analgesia.

Pharmacodynamics

In a salubrious volunteer report, ibuprofen 400 mg given once daily, administered two hours prior to immediate-release aspirin (81 mg) for 6 days, showed an interaction with the antiplatelet activity of aspirin every bit measured by % serum thromboxane B2 (TxB2) inhibition at 24 hours following the day-half-dozen aspirin dose [53%]. An interaction was still observed, merely minimized, when ibuprofen 400 mg given once-daily was administered every bit early on as 8 hours prior to the immediate-release aspirin dose [ninety.7%]. However, at that place was no interaction with the antiplatelet activity of aspirin when ibuprofen 400 mg, given once daily, was administered 2 hours after (but non concomitantly, 15 min, or xxx min after) the firsthand-release aspirin dose [99.ii%].

In another study, where immediate-release aspirin 81 mg was administered once daily with ibuprofen 400 mg given three times daily (1, 7, and 13 hours mail service-aspirin dose) for 10 consecutive days, the mean % serum thromboxane B2 (TxB2) inhibition suggested no interaction with the antiplatelet activity of aspirin [98.3%]. All the same, at that place were private subjects with serum TxB2 inhibition below 95%, with the everyman existence 90.2%.

When a similarly designed written report was conducted with enteric-coated aspirin, where healthy subjects were administered enteric-coated aspirin 81 mg once daily for 6 days and ibuprofen 400 mg three times daily (ii, 7 and 12 h post-aspirin dose) for 6 days, there was an interaction with the antiplatelet activity at 24 hours following the day-6 aspirin dose [67%]. [SeePrecautions / Drug Interactions ].

Pharmacokinetics

The ibuprofen in ibuprofen tablets is chop-chop absorbed. Elevation serum ibuprofen levels are generally attained one to two hours after assistants. With single doses upwards to 800 mg, a linear human relationship exists between amount of drug administered and the integrated area under the serum drug concentration vs time curve. Above 800 mg, however, the expanse nether the curve increases less than proportional to increases in dose. There is no evidence of drug accumulation or enzyme induction.

The administration of ibuprofen tablets either under fasting conditions or immediately before meals yields quite like serum ibuprofen concentration-time profiles. When ibuprofen tablets are administered immediately later on a meal, there is a reduction in the rate of absorption but no observable decrease in the extent of absorption. The bioavailability of the drug is minimally altered past the presence of food.

A bioavailability study has shown that there was no interference with the absorption of ibuprofen when ibuprofen tablets were given in conjunction with an antacid containing both aluminum hydroxide and magnesium hydroxide.

Ibuprofen is rapidly metabolized and eliminated in the urine. The excretion of ibuprofen is virtually complete 24 hours after the last dose. The serum half-life is 1.8 to ii.0 hours.

Studies have shown that following ingestion of the drug, 45% to 79% of the dose was recovered in the urine inside 24 hours equally metabolite A (25%), (+)-2-[p-(2hydroxymethyl-propyl) phenyl] propionic acrid and metabolite B (37%), (+)-2-[p-(2carboxypropyl)phenyl] propionic acid; the percentages of free and conjugated ibuprofen were approximately 1% and 14%, respectively.

INDICATIONS AND USAGE

Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (encounterWARNINGS ).

Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis.

Ibuprofen tablets are indicated for relief of mild to moderate pain.

Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea.

Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted.

CONTRAINDICATIONS

Ibuprofen tablets are contraindicated in patients with known hypersensitivity to Ibuprofen.

Ibuprofen tablets should non be given to patients who accept experienced asthma, urticaria, or allergic-type reactions subsequently taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-similar reactions to NSAIDs have been reported in such patients (seeWARNINGS,Anaphylactoid Reactions , andPRECAUTIONS  , Preexisting Asthma ).

Ibuprofen tablets are contraindicated in the setting of coronary artery featherbed graft (CABG) surgery (seeWARNINGS).

WARNINGS

Cardiovascular Furnishings

Cardiovascular Thrombotic Events

Clinical trials of several COX-2 selective and nonselective NSAIDs of upwardly to iii years elapsing take shown an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which tin exist fatal. Based upon bachelor information, information technology is unclear that the run a risk for CV thrombotic events is similar for all NSAIDs. The relative increase in serious CV thrombotic events over baseline conferred by NSAID use appears to be similar in those with and without known CV disease or risk factor for CV disease. However, patients with known CV illness or risk factors had a college absolute incidence of excess serious CV thrombotic events, due to their increased baseline charge per unit. Some observational studies found that this increased gamble of serious CV thrombotic events began as early as the beginning weeks of handling. The increase in CV thrombotic adventure has been observed most consistently at higher doses.

To minimize the potential risk for an adverse CV event in NSAID-treated patients, utilize the lowest effective dose for the shortest duration possible. Physicians and patients should remain warning for the development of such events, throughout the entire handling form, even in the absence of previous CV symptoms. Patients should exist informed about the symptoms of serious CV events and the steps to take if they occur.

In that location is no consistent evidence that concurrent use of aspirin mitigates the increased hazard of serious CV thrombotic events associated with NSAID employ. The concurrent use of aspirin and an NSAID, such as Ibuprofen, increases the run a risk of serious gastrointestinal (GI) events (run acrossWARNINGS).

Condition Post Coronary Artery Featherbed Graft (CABG) Surgery

Two large, controlled clinical trials of a COX-2 selective NSAID for the handling of pain in the first 10-xiv days post-obit CABG surgery found an increased incidence of myocardial infarction and stroke. NSAIDs are contraindicated in the setting of CABG (see CONTRAINDICATIONS).

Postal service-MI Patients

Observational studies conducted in the Danish National Registry take demonstrated that patients treated with NSAIDs in the post-MI catamenia were at increased risk of reinfarction, CV-related decease, and all-cause mortality starting time in the starting time week of treatment. In this same accomplice, the incidence of decease in the showtime year post MI was twenty per 100 person years in NSAID-treated patients compared to 12 per 100 person years in non-NSAID exposed patients. Although the accented rate of expiry declined somewhat subsequently the first yr mail service-MI, the increased relative take a chance of death in NSAID users persisted over at least the next four years of follow-up.

Avert the use of Ibuprofen tablets in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If Ibuprofen tablets are used in patients with recent MI, monitor patients for signs of cardiac ischemia.

Hypertension

NSAIDs including ibuprofen tablets, can lead to onset of new hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of CV events. Patients taking thiazides or loop diuretics may accept impaired response to these therapies when taking NSAIDs. NSAIDs, including ibuprofen tablets, should exist used with caution in patients with hypertension. Blood pressure level (BP) should be monitored closely during the initiation of NSAID treatment and throughout the course of therapy.

Heart Failure and Edema

The Coxib and traditional NSAID Trialists' Collaboration meta-analysis of randomized controlled trials demonstrated an approximately two-fold increase in hospitalizations for heart failure in COX-2 selective-treated patients and nonselective NSAID-treated patients compared to placebo-treated patients. In a Danish National Registry written report of patients with heart failure, NSAID use increased the risk of MI, hospitalization for middle failure, and death.

Additionally, fluid memory and edema have been observed in some patients treated with NSAIDs. Use of Ibuprofen may edgeless the CV furnishings of several therapeutic agents used to treat these medical atmospheric condition [due east.g., diuretics, ACE inhibitors, or angiotensin receptor blockers (ARBs)] [seeDrug Interactions].

Avoid the utilize of Ibuprofen tablets in patients with severe heart failure unless the benefits are expected to outweigh the risk of worsening eye failure. If Ibuprofen tablets are used in patients with astringent middle failure, monitor patients for signs of worsening centre failure.

Gastrointestinal Effects-Risk of Ulceration, Bleeding, and Perforation

NSAIDs, including ibuprofen tablets, can cause serious gastrointestinal (GI) agin events including inflammation, bleeding, ulceration, and perforation of the tummy, modest intestine, or big intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Only 1 in five patients, who develop a serious upper GI adverse issue on NSAID therapy, is symptomatic. Upper GI ulcers, gross bleeding, or perforation caused by NSAIDs occur in approximately 1% of patients treated for 3-vi months, and in about 2-4% of patients treated for one yr. These trends go on with longer elapsing of use, increasing the likelihood of developing a serious GI event at some time during the course of therapy. All the same, even short-term therapy is non without risk. NSAIDs should be prescribed with extreme caution in those with a prior history of ulcer affliction or gastrointestinal bleeding. Patients with a prior history of peptic ulcer affliction and/or gastrointestinal bleeding who use NSAIDs have a greater than 10-fold increased risk for developing a GI bleed compared to patients treated with neither of these risk factors. Other factors that increase the risk of GI bleeding in patients treated with NSAIDs include concomitant use of oral corticosteroids or anticoagulants, longer duration of NSAID therapy, smoking, use of booze, older age, and poor general wellness status. Nearly spontaneous reports of fatal GI events are in elderly or debilitated patients and therefore, special care should be taken in treating this population.

To minimize the potential risk for an adverse GI outcome in patients treated with an NSAID, the lowest effective dose should be used for the shortest possible duration. Patients and physicians should remain warning for signs and symptoms of GI ulcerations and bleeding during NSAID therapy and promptly initiate boosted evaluation and treatment if a serious GI outcome is suspected. This should include discontinuation of the NSAID until a serious GI adverse effect is ruled out. For high-chance patients, alternate therapies that do not involve NSAIDs should be considered.

Renal Effects

Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Renal toxicity has likewise been seen in patients in whom renal prostaglandins have a compensatory office in the maintenance of renal perfusion. In these patients, administration of a NSAID may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood menstruation, which may precipitate overt renal decompensation. Patients at greatest risk of this reaction are those with impaired renal office, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors, and the elderly. Discontinuation of NSAID therapy is commonly followed by recovery to the pretreatment state.

Advanced Renal Disease

No information is available from controlled clinical studies regarding the employ of ibuprofen tablets in patients with advanced renal disease. Therefore, treatment with ibuprofen tablets is not recommended in these patients with advanced renal disease. If ibuprofen tablet therapy must be initiated, close monitoring of the patients renal office is advisable.


Anaphylactoid Reactions

Every bit with other NSAIDs, anaphylactoid reactions may occur in patients without known prior exposure to ibuprofen tablets. Ibuprofen tablets should not be given to patients with the aspirin triad. This symptom complex typically occurs in asthmatic patients who experience rhinitis with or without nasal polyps, or who exhibit astringent, potentially fatal bronchospasm after taking aspirin or other NSAIDs (meetCONTRAINDICATIONS andPRECAUTIONS ,Preexisting Asthma). Emergency aid should be sought in cases where an anaphylactoid reaction occurs.

Pare Reactions

NSAIDs, including ibuprofen tablets, can crusade serious skin agin events such equally exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (Ten), which can exist fatal. These serious events may occur without alarm. Patients should be informed about the signs and symptoms of serious skin manifestations and utilize of the drug should exist discontinued at the first appearance of skin rash or any other sign of hypersensitivity.

Drug Reaction with Eosinophilia and Systemic Symptoms (Apparel)

Drug Reaction with Eosinophilia and Systemic Symptoms (Apparel) has been reported in patients taking NSAIDs such as ibuprofen tablets. Some of these events have been fatal or life-threatening. Wearing apparel typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling. Other clinical manifestations may include hepatitis, nephritis, hematological abnormalities, myocarditis, or myositis. Sometimes symptoms of Wearing apparel may resemble an acute viral infection. Eosinophilia is oftentimes present. Considering this disorder is variable in its presentation, other organ systems not noted here may be involved. It is important to note that early manifestations of hypersensitivity, such as fever or lymphadenopathy, may exist present even though rash is not evident. If such signs or symptoms are present, discontinue ibuprofen tablets and evaluate the patient immediately.

Fetal Toxicity

Premature Closure of Fetal Ductus Arteriosus:
Avoid utilize of NSAIDs, including ibuprofen tablets, in meaning women at about thirty weeks gestation and later on. NSAIDs including ibuprofen tablets, increase the run a risk of premature closure of the fetal ductus arteriosus at approximately this gestational historic period.

Oligohydramnios/Neonatal Renal Impairment:
Use of NSAIDs, including ibuprofen tablets, at about xx weeks gestation or later in pregnancy may crusade fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. These adverse outcomes are seen, on average, later on days to weeks of treatment, although oligohydramnios has been infrequently reported as presently as 48 hours after NSAID initiation. Oligohydramnios is often, but not ever, reversible with treatment discontinuation. Complications of prolonged oligohydramnios may, for example, include limb contractures and delayed lung maturation. In some postmarketing cases of dumb neonatal renal part, invasive procedures such equally exchange transfusion or dialysis were required.
If NSAID treatment is necessary betwixt about 20 weeks and 30 weeks gestation, limit ibuprofen tablets employ to the lowest effective dose and shortest duration possible. Consider ultrasound monitoring of amniotic fluid if ibuprofen tablets treatment extends across 48 hours. Discontinue ibuprofen tablets if oligohydramnios occurs and follow up co-ordinate to clinical practice [encounter PRECAUTIONS; Pregnancy].

PRECAUTIONS

Full general

Ibuprofen tablets cannot be expected to substitute for corticosteroids or to care for corticosteroid insufficiency. Sharp discontinuation of corticosteroids may lead to disease exacerbation. Patients on prolonged corticosteroid therapy should have their therapy tapered slowly if a conclusion is made to discontinue corticosteroids.

The pharmacological activity of ibuprofen tablets in reducing fever and inflammation may diminish the utility of these diagnostic signs in detecting complications of presumed noninfectious, painful conditions.

Hepatic effects

Borderline elevations of one or more liver tests may occur in up to fifteen% of patients taking NSAIDs, including ibuprofen tablets. These laboratory abnormalities may progress, may remain unchanged, or may exist transient with standing therapy. Notable elevations of ALT or AST (approximately three or more times the upper limit of normal) have been reported in approximately 1% of patients in clinical trials with NSAIDs. In add-on, rare cases of severe hepatic reactions, including jaundice, fulminant hepatitis, liver necrosis, and hepatic failure, some of them with fatal outcomes have been reported.

A patient with symptoms and/or signs suggesting liver dysfunction, or with aberrant liver test values, should be evaluated for show of the development of a more severe hepatic reaction while on therapy with ibuprofen tablets. If clinical signs and symptoms consistent with liver affliction develop, or if systemic manifestations occur (east.m., eosinophilia, rash, etc.), ibuprofen tablets should be discontinued.

Hematological effects

Anemia is sometimes seen in patients receiving NSAIDs, including ibuprofen tablets. This may be due to fluid retention, occult or gross GI claret loss, or an incompletely described effect upon erythropoiesis. Patients on long-term treatment with NSAIDs, including ibuprofen tablets, should have their hemoglobin or hematocrit checked if they exhibit any signs or symptoms of anemia.

In two postmarketing clinical studies the incidence of a decreased hemoglobin level was greater than previously reported. Decrease in hemoglobin of 1 gram or more was observed in 17.one% of 193 patients on 1600 mg ibuprofen daily (osteoarthritis), and in 22.8% of 189 patients taking 2400 mg of ibuprofen daily (rheumatoid arthritis). Positive stool occult blood tests and elevated serumcreatinine levels were also observed in these studies.

NSAIDs inhibit platelet aggregation and accept been shown to prolong bleeding time in some patients. Unlike aspirin, their issue on platelet function is quantitatively less, of shorter duration, and reversible.

Patients receiving ibuprofen tablets who may exist adversely affected by alterations in platelet function, such as those with coagulation disorders or patients receiving anticoagulants should be advisedly monitored.

Preexisting asthma

Patients with asthma may take aspirin-sensitive asthma. The apply of aspirin in patients with aspirin-sensitive asthma has been associated with severe bronchospasm, which can exist fatal. Since cantankerous reactivity, including bronchospasm, betwixt aspirin and NSAIDs has been reported in such aspirin-sensitive patients, ibuprofen tablets should non be administered to patients with this grade of aspirin sensitivity and should be used with caution in patients with preexisting asthma.

Ophthalmological furnishings

Blurred and/or macerated vision, scotomata, and/or changes in color vision have been reported. If a patient develops such complaints while receiving ibuprofen tablets, the drug should be discontinued, and the patient should have an ophthalmologic examination which includes key visual fields and color vision testing.

Hygienic meningitis

Aseptic meningitis with fever and coma has been observed on rare occasions in patients on ibuprofen therapy. Although it is probably more likely to occur in patients with systemic lupus erythematosus and related connective tissue diseases, it has been reported in patients who practise not have an underlying chronic disease. If signs or symptoms of meningitis develop in a patient on ibuprofen tablets, the possibility of its being related to ibuprofen tablets should be considered.

Data for Patients

Patients should exist informed of the following data earlier initiating therapy with an NSAID and periodically during the course of ongoing therapy. Patients should also be encouraged to read the NSAID Medication Guide that accompanies each prescription dispensed.

  • Cardiovascular Thrombotic Events

Suggest patients to be alert for the symptoms of cardiovascular thrombotic events, including chest pain, shortness of breath, weakness, or slurring spoken communication, and to report whatever of these symptoms to their wellness care provider immediately [meetWARNINGS].

  • Ibuprofen tablets, similar other NSAIDs, tin cause GI discomfort and, rarely, serious GI side effects, such equally ulcers and bleeding, which may result in hospitalization and fifty-fifty death. Although serious GI tract ulcerations and bleeding tin occur without alarm symptoms, patients should be alarm for the signs and symptoms of ulcerations and haemorrhage, and should ask for medical communication when observing whatever indicative signs or symptoms including epigastric pain, dyspepsia, melena, and hematemesis. Patients should be apprised of the importance of this follow-up (seeWARNINGS,Gastrointestinal Effects  -Gamble of Ulceration,Bleeding and Perforation).
  • Ibuprofen tablets, like other NSAIDs, tin can crusade serious pare side effects such as exfoliative dermatitis, SJS and TEN, which may consequence in hospitalization and even death. Although serious skin reactions may occur without warning, patients should be alert for the signs and symptoms of skin rash and blisters, fever, or other signs hypersensitivity such equally itching, and should enquire for medical advice when observing any indicative sign or symptoms. Patients should be brash to stop the drug immediately if they develop any type of rash and contact their physicians as presently equally possible
  • Serious Skin Reactions, including DRESS
    Advise patients to finish taking ibuprofen tablets immediately if they develop any type of rash or fever and to contact their healthcare provider every bit soon as possible [ see Warnings ].
  • Middle Failure And Edema

Suggest patients to be alert for the symptoms of congestive heart failure including shortness of jiff, unexplained weight proceeds, or edema and to contact their healthcare provider if such symptoms occur [meet WARNINGS ].

  • Patients should be informed of the alert signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, jaundice, correct upper quadrant tenderness and "flu-similar" symptoms). If these occur, patients should exist instructed to cease therapy and seek firsthand medical therapy.
  • Patients should be informed of the signs of an anaphylactoid reaction (e.g. difficulty breathing, swelling of the confront or throat). If these occur, patients should be instructed to seek firsthand emergency help (see WARNINGS ).
  • Fetal Toxicity
    Inform pregnant women to avoid employ of ibuprofen tablets and other NSAIDs starting at xxx weeks gestation because of the risk of the premature closing of the fetal ductus arteriosus. If treatment with ibuprofen tablets is needed for a meaning woman between about 20 to 30 weeks gestation, advise her that she may need to exist monitored for oligohydramnios, if treatment continues for longer than 48 hours [ run into WARNINGS; Fetal Toxicity , PRECAUTIONS; Pregnancy ].

Laboratory Tests

Because serious GI tract ulcerations and bleeding can occur without warning symptoms, physicians should monitor for signs or symptoms of GI haemorrhage. Patients on long-term treatment with NSAIDs should have their CBC and chemistry profile checked periodically. If clinical signs and symptoms consistent with liver or renal disease develop, systemic manifestations occur (due east.1000., eosinophilia, rash etc.), or abnormal liver tests persist or worsen, ibuprofen tablets should be discontinued.

Drug Interactions

ACE-inhibitors

Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE-inhibitors. This interaction should be given consideration in patients taking NSAIDs concomitantly with ACE-inhibitors.

Aspirin

Pharmacodynamic studies take demonstrated interference with the antiplatelet activity of aspirin when ibuprofen 400 mg, given three times daily, is administered with enteric coated depression-dose aspirin. The interaction exists even following a once-daily regimen of ibuprofen 400 mg, peculiarly when ibuprofen is dosed prior to aspirin. The interaction is alleviated if immediate-release low-dose aspirin is dosed at least 2 hours prior to a once daily regimen of ibuprofen; yet, this finding cannot be extended to enteric-coated low-dose aspirin [seeClinical Pharmacology / Pharmacodynamics ].

Because there may be an increased risk of cardiovascular events due to the interference of ibuprofen with the antiplatelet effect of aspirin, for patients taking depression-dose aspirin for cardio protection who require analgesics, consider utilise of an NSAID that does not interfere with the antiplatelet consequence of aspirin, or non-NSAID analgesics, where appropriate.

When ibuprofen tablets are administered with aspirin, its poly peptide binding is reduced, although the clearance of gratis ibuprofen tablets is not altered. The clinical significance of this interaction is not known; still, as with other NSAIDs, concomitant assistants of ibuprofen and aspirin is non by and large recommended considering of the potential for increased adverse effects.

Diuretics

Clinical studies, equally well every bit post marketing observations, have shown that ibuprofen tablets tin reduce the natriuretic consequence-of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis. During concomitant therapy with NSAIDs, the patient should be observed closely for signs of renal failure (see WARNINGS , Renal Effects ), every bit well as to assure diuretic efficacy.

Lithium

Ibuprofen produced an acme of plasma lithium levels and a reduction in renal lithium clearance in a written report of eleven normal volunteers. The mean minimum lithium concentration increased 15% and the renal clearance of lithium was decreased by 19% during this period of concomitant drug administration. This effect has been attributed to inhibition of renal prostaglandin synthesis by ibuprofen. Thus, when ibuprofen and lithium are administered concurrently, subjects should exist observed advisedly for signs of lithium toxicity. (Read circulars for lithium grooming before apply of such concurrent therapy).

Methotrexate

NSAIDs have been reported to competitively inhibit methotrexate aggregating in rabbit kidney slices. This may indicate that they could raise the toxicity of methotrexate. Circumspection should be used when NSAIDs are administered concomitantly with methotrexate.

Warfarin-blazon anticoagulants

Several short-term controlled studies failed to show that ibuprofen tablets significantly affected prothrombin times or a diversity of other clotting factors when administered to individuals on coumarin-blazon anticoagulants. Yet, because haemorrhage has been reported when ibuprofen tablets and other NSAIDs accept been administered to patients on coumarin-type anticoagulants, the physician should be cautious when administering ibuprofen tablets to patients on anticoagulants. The furnishings of warfarin and NSAIDs on GI haemorrhage are synergistic, such that the users of both drugs together accept a risk of serious GI bleeding higher than users of either drug alone.

H-2 Antagonists

In studies with homo volunteers, co-administration of cimetidine or ranitidine with ibuprofen had no substantive effect on ibuprofen serum concentrations.

Pregnancy

Run a risk Summary
Utilize of NSAIDs, including ibuprofen tablets, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. Considering of these risks, limit dose and duration of ibuprofen tablets use between about twenty and thirty weeks of gestation, and avoid ibuprofen tablets use at about 30 weeks of gestation and afterwards in pregnancy [ see WARNINGS ; Fetal Toxicity ].

Premature Closure of Fetal Ductus Arteriosus
Use of NSAIDs, including ibuprofen tablets, at about 30 weeks gestation or later in pregnancy increases the risk of premature closure of the fetal ductus arteriosus.


Oligohydramnios/Neonatal Renal Impairment
Use of NSAIDs at nigh twenty weeks gestation or later in pregnancy has been associated with cases of fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal damage.

Data from observational studies regarding other potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive.  Reproductive studies conducted in rats and rabbits have not demonstrated prove of developmental abnormalities. Even so, beast reproduction studies are not always predictive of human response. Based on animal data, prostaglandins have been shown to take an of import role in endometrial vascular permeability, blastocyst implantation, and decidualization. In creature studies, administration of prostaglandin synthesis inhibitors such as ibuprofen, resulted in increased pre- and mail-implantation loss. Prostaglandins also have been shown to take an important part in fetal kidney evolution. In published fauna studies, prostaglandin synthesis inhibitors have been reported to impair kidney development when administered at clinically relevant doses.

The estimated groundwork adventure of major nativity defects and miscarriage for the indicated population(s) is unknown. All pregnancies have a groundwork risk of nativity defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major nascency defects and miscarriage in clinically recognized pregnancies is 2-four% and 15-20%, respectively.

Clinical Considerations

Fetal/Neonatal Adverse Reactions

Premature Closure of Fetal Ductus Arteriosus:
Avoid use of NSAIDs in women at nearly 30 weeks gestation and later in pregnancy, because NSAIDs, including ibuprofen tablets, tin cause premature closure of the fetal ductus arteriosus (run into WARNINGS ; Fetal Toxicity ).

Oligohydramnios/Neonatal Renal Impairment
If an NSAID is necessary at about 20 weeks gestation or later on in pregnancy, limit the use to the lowest constructive dose and shortest duration possible. If ibuprofen tablets treatment extends across 48 hours, consider monitoring with ultrasound for oligohydramnios. If oligohydramnios occurs, discontinue ibuprofen tablets and follow up co-ordinate to clinical practice ( meet WARNINGS ; Fetal Toxicity ).

Data

Homo Information

There are no adequate, well-controlled studies in pregnant women. Ibuprofen tablets should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.

Premature Closure of Fetal Ductus Arteriosus:
Published literature reports that the employ of NSAIDs at about 30 weeks of gestation and later in pregnancy may crusade premature closure of the fetal ductus arteriosus.

Oligohydramnios/Neonatal Renal Damage:
Published studies and postmarketing reports describe maternal NSAID use at about 20 weeks gestation or afterward in pregnancy associated with fetal renal dysfunction leading to oligohydramnios, and in some cases,
neonatal renal impairment. These agin outcomes are seen, on average, after days to weeks of treatment, although oligohydramnios has been infrequently reported as soon as 48 hours after NSAID initiation. In many cases, but not all, the subtract in amniotic fluid was transient and reversible with abeyance of the drug. There have been a limited number of case reports of maternal NSAID use and neonatal renal dysfunction without oligohydramnios, some of which were irreversible. Some cases of neonatal renal dysfunction required handling with invasive procedures, such as exchange transfusion or dialysis.

Methodological limitations of these postmarketing studies and reports include lack of a command group; limited information regarding dose, elapsing, and timing of drug exposure; and concomitant utilize of other medications. These limitations preclude establishing a reliable estimate of the risk of adverse fetal and neonatal outcomes with maternal NSAID use. Because the published safety data on neonatal outcomes involved mostly preterm infants, the generalizability of certain reported risks to the full-term infant exposed to NSAIDs through maternal use is uncertain.

Labor And Delivery

In rat studies with NSAIDs, as with other drugs known to inhibit prostaglandin synthesis, an increased incidence of dystocia, delayed parturition, and decreased pup survival occurred. The effects of ibuprofen tablets on labor and delivery in significant women are unknown.


Nursing Mothers

It is not known whether this drug is excreted in man milk. Because many drugs are excreted in human-milk and because of the potential for serious adverse reactions in nursing infants from ibuprofen tablets, a conclusion should be fabricated whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Prophylactic and effectiveness of ibuprofen tablets in pediatric patients have not been established.

Geriatric Utilize

Equally with any NSAIDs, caution should be exercised in treating the elderly (65 years and older).

Adverse REACTIONS

The most frequent type of adverse reaction occurring with ibuprofen tablets is gastrointestinal . In controlled clinical trials the per centum of patients reporting one or more than gastrointestinal complaints ranged from 4% to 16%.

In controlled studies when ibuprofen tablets were compared to aspirin and indomethacin in every bit constructive doses, the overall incidence of gastrointestinal complaints was nigh half that seen in either the aspirin- or indomethacin-treated patients.

Adverse reactions observed during controlled clinical trials at an incidence greater than 1% are listed in the table. Those reactions listed in Column ane encompass observations in approximately three,000 patients. More than than 500 of these patients were treated for periods of at least 54 weeks.

Notwithstanding other reactions occurring less oftentimes than one in 100 were reported in controlled clinical trials and from marketing experience. These reactions have been divided into two categories: Column 2 of the tabular array lists reactions with therapy with ibuprofen tablets where the probability of a causal relationship exists: for the reactions in Cavalcade three, a causal relationship with ibuprofen tablets has not been established.

Reported side effects were higher at doses of 3200 mg/24-hour interval than at doses of 2400 mg or less per 24-hour interval in clinical trials of patients with rheumatoid arthritis . The increases in incidence were slight and still within the ranges reported in the table.


Incidence Greater than 1%(but less than 3%) probable casual Human relationship
Precise Incidence Unknown (but less than 1%) probable Casual Relationship* Precise Incidence Unknown (merely less than one%) Casual Human relationship Unknown*

GASTROINTESTINAL

Nausea†, epigastric paint†, heartburn, diarrhea, intestinal distress, nausea and vomiting, indigestion, constipation, abdominal cramps or Pain, fullness of GI tract (bloating and flatulence)

  Gastric or duodenal ulcer with bleeding and/or perforation, gastrointestinal hemorrhage, melena, gastritis, hepatitis, jaundice, abnormal liver function tests; pancreatitis


Primal NERVOUS SYSTEM

  Dizziness†, headache, nervousness

    Low, indisposition, confusion, emotional liability, somnolence, aseptic meningitis with fever and coma (come acrossPRECAUTIONS)

    Paresthesias, hallucinations, dream abnormalities, pseudo-tumor cerebri


DERMATOLOGIC

  Rash† (including maculopapular type), pruritis

  Vesiculobullous eruptions, urticaria, erythema multiforme, Stevens-Johnson syndrome, alopecia

  Toxic epidermal necrolysis, photoallergic skin reactions


SPECIAL SENSES

  Tinnitus

  Hearing loss, amblyopia (blurred and/or macerated vision, scotomata and/or changes in color vision) (seePRECAUTIONS)

  Conjunctivitis, diplopia, optic neuritis, cataracts


HEMATOLOGIC

  Neutropenia, agranulocytosis, aplastic anemia, hemolytic anemia (sometimes Coombs positive), thrombocytopenia with or without purpura, eosinophilia, decreases in hemoglobin and hematocrit (run intoPRECAUTIONS)

  Haemorrhage episodes (eg epistaxis, menorrhagia)


METABOLIC/ENDOCRINE

    Decreased ambition

    Gynecomastia, hypoglycemic reaction, acidosis


CARDIOVASCULAR

    Edema, fluid retention (generally responds promptly to drug discontinuation) (run acrossPRECAUTIONS)

    Congestive heart failure in patients with marginal cardiac part elevated claret pressure, palpitations

    Arrhythmias (sinus tachycardia, sinus bradycardia)


ALLERGIC

    Syndrome of abdominal pain, fever, chills, nausea and vomiting; anaphylaxis; bronchospasm (encounterCONTRADICATIONS )

    Serum sickness, lupus erythematosus syndrome, Henoch-Schonlein vasculitis, angioedema


RENAL

  Acute renal failure (meetPRECAUTIONS ), decreased creatinine clearance, polyuria, azotemia, cystitis, Hematuria

  Renal papillary necrosis


MISCELLANEOUS

    Dry eyes and mouth, gingival ulcer, rhinitis

*Reactions are classified nether "Likely Causal Relationship (PCR)" if there has been one positive rechallenge or if iii or more than cases occur which might be causally related. Reactions are classified under "Causal Relationship Unknown" if seven or more than events have been reported but the criteria for PCR have not been met.
†Reactions occurring in 3%to 9%of patients treated with ibuprofen tablets. (Those reactions occurring in less than 3%of the patients are unmarked).

To written report SUSPECTED Agin REACTIONS, contact Marksans at 1-877-376-4271 or FDA at ane-800-FDA-1088 or www.fda.gov/medwatch.


OVERDOSAGE

Approximately 1½ hours afterwards the reported ingestion of from 7 to 10 ibuprofen tablets (400 mg), a 19-month erstwhile child weighing 12 kg was seen in the hospital emergency room, apneic and cyanotic, responding but to painful stimuli. This type of stimulus, yet, was sufficient to induce respiration. Oxygen and parenteral fluids were given; a greenish-yellow fluid was aspirated from the stomach with no show to indicate the presence of ibuprofen. Two hours after ingestion the child'south condition seemed stable; she still responded only to painful stimuli and continued to have periods of apnea lasting from v to x seconds. She was admitted to intensive intendance and sodium bicarbonate was administered also as infusions of dextrose and normal saline. Past four hours mail-ingestion she could exist aroused easily, sit past herself and answer to spoken commands. Blood level of ibuprofen was 102.9 µg/mL approximately 8½ hours after accidental ingestion. At 12 hours she appeared to be completely recovered.

In ii other reported cases where children (each weighing approximately ten kg) accidentally, acutely ingested approximately 120 mg/kg, there were no signs of acute intoxication or late sequelae. Blood level in one child xc minutes after ingestion was 700 µg/mL — about x times the tiptop levels seen in absorption-excretion studies.

A 19-yr quondam male who had taken 8,000 mg of ibuprofen over a period of a few hours complained of dizziness, and nystagmus was noted. After hospitalization, parenteral hydration and three days bed rest, he recovered with no reported sequelae.

In cases of astute overdosage, the stomach should be emptied by vomiting or lavage, though little drug volition likely be recovered if more than an hour has elapsed since ingestion. Because the drug is acidic and is excreted in the urine, information technology is theoretically benign to administer alkali and induce diuresis. In addition to supportive measures, the use of oral activated charcoal may assistance to reduce the absorption and reabsorption of ibuprofen tablets.

DOSAGE AND ADMINISTRATION

Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen tablets. Use the lowest effective dose for the shortest duration consequent with individual patient treatment goals (seeWARNINGS  ).

Afterward observing the response to initial therapy with ibuprofen tablets, the dose and frequency should be adjusted to suit an private patient'due south needs.

Practice non exceed 3200 mg total daily dose. If gastrointestinal complaints occur, administrate ibuprofen tablets with meals or milk.

Rheumatoid arthritis and osteoarthritis, including flare-ups of chronic disease

Suggested Dosage: 1200 mg-3200 mg daily (300 mg qid; 400 mg, 600 mg or 800 mg tid or qid). Individual patients may prove a meliorate response to 3200 mg daily, as compared with 2400 mg, although in well-controlled clinical trials patients on 3200 mg did not evidence a better mean response in terms of efficacy. Therefore, when treating patients with 3200 mg/day, the md should observe sufficient increased clinical benefits to offset potential increased risk.

The dose should be tailored to each patient, and may be lowered or raised depending on the severity of symptoms either at fourth dimension of initiating drug therapy or equally the patient responds or fails to respond.

In general, patients with rheumatoid arthritis seem to require higher doses of ibuprofen tablets than do patients with osteoarthritis.

The smallest dose of ibuprofen tablets that yields adequate control should be employed. A linear blood level dose-response relationship exists with single doses upwardly to 800 mg (Come acrossCLINICAL PHARMACOLOGY for furnishings of food on rate of absorption).

The availability of four tablet strengths facilitates dosage adjustment.

In chronic atmospheric condition, a therapeutic response to therapy with ibuprofen tablets is sometimes seen in a few days to a calendar week but most often is observed by 2 weeks. Afterwards a satisfactory response has been achieved, the patient's dose should be reviewed and adjusted as required.

Mild to moderate pain: 400 mg every 4 to 6 hours as necessary for relief of hurting.

In controlled analgesic clinical trials, doses of ibuprofen tablets greater than 400 mg were no more than effective than the 400 mg dose.

Dysmenorrhea

For the treatment of dysmenorrhea, commencement with the primeval onset of such pain, ibuprofen tablets should be given in a dose of 400 mg every iv hours every bit necessary for the relief of pain.

HOW SUPPLIED

Ibuprofen tablets are available in the following strengths:

400 mg (white to off white, circular, biconvex, flick coated tablets debossed with '121' on i side and plain on other side)

Bottles of 30             (NDC 25000-121-03)

Bottles of 500           (NDC 25000-121-12)

Bulk  (six x 3500)        (NDC 25000-121-29)

600 mg (white to off white, sheathing shaped, biconvex, flick coated tablets debossed with '122' on one side and patently on other side)

Bottles of 30             (NDC 25000-122-03)

Bottles of 500            (NDC 25000-122-12)

 Bulk  (6 ten 2500)        (NDC 25000-122-28)

800 mg (white to off white, sheathing shaped, biconvex, picture show coated tablets debossed with '123' on one side and patently on other side)

Bottles of 30             (NDC 25000-123-03)

Bottles of 500            (NDC 25000-123-12)

Bulk  (6 10 1900)        (NDC 25000-123-27)

"Preserve in well-closed containers"

Store at twenty ° to 25°C (68°to 77°F) [Meet USP Controlled Room Temperature]

Rx only

Manufactured for:

Fourth dimension-Cap Labs, Inc.

7 Michael Artery,

Farmingdale, NY 11735, U.s.

Manufactured past:

Marksans Pharma Ltd.

Plot No. L-82, L-83 Verna Indl. Estate

Verna, Goa-403 722, India

Iss. 02/22

SPL Medguide

Medication Guide for Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

What is the most important data I should know almost medicines chosen Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)?

NSAIDs can cause serious side effects, including:

  • Increased chance of a centre attack or stroke that can lead to expiry. This risk may happen early in handling and may increment:
    • with increasing doses of NSAIDs
    • with longer apply of NSAIDs

Do not take NSAIDs right before or later on a heart surgery called a "coronary artery     featherbed graft (CABG)."

Avoid taking NSAIDs after recent middle attack, unless your healthcare provider tells you to. Y'all may have an increased risk of another heart attack if you take NSAIDs after a recent heart assault.

  • Increased chance of bleeding, ulcers and tears (perforation) of the esophagus (tube leading from the oral cavity to the breadbasket), stomach and intestines:
    • someday during use
    • without warning symptoms
    • that may cause death

The chance of getting an ulcer or bleeding increases with:

  • past history of tummy ulcers, or tum or intestinal bleeding with employ of NSAIDs
  • taking medicines called "corticosteroids", "anticoagulants", "SSRIs", or "SNRIs"
  • increasing doses of NSAIDs
  • older age
  • longer use of NSAIDs
  • poor health
  • smoking
  • advanced liver disease
  • drinking alcohol
  • bleeding problems

NSAIDs should simply exist used:

  • exactly as prescribed
  • at the everyman dose possible for your treatment
  • for the shortest fourth dimension needed

What are NSAIDs?

NSAIDs are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such equally different types of arthritis, menstrual cramps and other types of short-term pain.

Who should not take NSAIDs?

Do not accept NSAIDs:

  • if you have had an asthma set on, hives, or other allergic reaction with aspirin or any other NSAIDs
  • right before or later on heart bypass surgery.

Before taking NSAIDs tell your healthcare provider about all of your medical conditions, including if you lot:

  • have liver or kidney problems
  • loftier blood pressure level
  • accept asthma
  • are pregnant or plan to become pregnant. Taking NSAIDs at about xx weeks of pregnancy or later may impairment your unborn babe. If you need to take NSAIDs for more than 2 days when you lot are between twenty and 30 weeks of pregnancy, your healthcare provider may need to monitor the amount of fluid in your womb around your baby. You should not take NSAIDs after nigh 30 weeks of pregnancy
  • are chest feeding or programme to breast feed.

Tell your healthcare provider nearly all of the medicines you take, including prescription or over-the-counter medicines, vitamins or herbal supplements. NSAIDs and some other medicines tin interact witheach other and cause serious side effects. Do not beginning taking any new medicine without talking to your healthcare provider first.

What are the possible side furnishings of NSAIDs?

NSAIDs can cause serious side furnishings, including:

Run into "What is the nigh important data I should know virtually medicines chosen Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?

  • new or worse high blood pressure
  • centre failure
  • liver problems including liver failure
  • kidney issues including kidney failure
  • low red claret cells (anemia)
  • life-threatening skin reactions
  • life-threatening allergic reactions
  • Other side furnishings of NSAIDs include: stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting, and dizziness.

Get emergency help right away if you get any of the following symptoms:

  • shortness of breath or problem breathing
  • chest pain
  • weakness in one part or side of your torso
  • slurred speech
  • swelling of the face or throat

Stop taking your NSAID and call your healthcare provider right away if yous get whatsoever of the post-obit symptoms:

  • nausea
  • more tired or weaker than usual
  • diarrhea
  • itching
  • your skin or optics look yellow
  • indigestion or stomach hurting
  • flu-similar symptoms
  • vomit blood
  • in that location is blood in your bowel movement or it is black and viscid like tar
  • unusual weight gain
  • skin rash or blisters with fever
  • swelling of the arms, legs, hands and anxiety

If you take also much of your NSAID, Call your healthcare provider or become medical help correct away.

These are non all the possible side furnishings of NSAIDs. For more information, inquire your healthcare provider or pharmacist about NSAIDs.

Telephone call your doctor for medical communication virtually side effects. You may report side effects to FDA at    1-800-FDA-1088.

Other data almost NSAIDs

  • Aspirin is an NSAID only it does not increase the risk of a heart attack. Aspirin can cause bleeding in the brain, stomach, and intestines. Aspirin can also crusade ulcers in the tum and intestines.
  • Some NSAIDs are sold in lower doses without a prescription (over-the counter). Talk to your healthcare provider earlier using over-the-counter NSAIDs for more than x days.

General information almost the safe and constructive use of NSAIDs

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use NSAIDs for a status for which information technology was not prescribed. Do not give NSAIDs to other people, fifty-fifty if they have the same symptoms that you accept. It may harm them.

If you would like more information nigh NSAIDs, talk with your healthcare provider. You can ask your chemist or healthcare provider for information about NSAIDs that is written for health professionals.

This Medication Guide has been canonical by the U.S. Food and Drug Administration.

Manufactured for:

Fourth dimension-Cap Labs, Inc.

7 Michael Avenue,

Farmingdale, NY 11735, USA


Manufactured by:

Marksans Pharma Ltd.

Plot No. L-82, L-83, Verna Indl. Manor,

Verna, Goa-403 722, India

Iss. 02/22

Bundle LABEL.PRINCIPAL Brandish PANEL

Ibuprofen Tablets, USP 400 mg - 30's Bottle characterization
NDC 25000-121-03

ibu400mg-30bot-labl

PRINICPAL Display PANEL 400 mg -500'south count

ibu400mg

Package LABEL.PRINCIPAL Display Panel

Ibuprofen Tablets, USP 600mg-30-canteen count
NDC 25000-122-03

ibu600mg-30bott-labl

PRINICPAL DISPLAY Panel 600 mg -500's count

ibu600mg


Bundle LABEL.Primary DISPLAY PANEL

Ibuprofen Tablets, USP 800 mg
NDC 25000-123-03

ibu800mg-30bott-labl

PRINICPAL Display Panel 800 mg -500's count

ibu800mg

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Source: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=e54209c2-f726-440b-ac60-5a72710d2a9b

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