IBU- ibu tablet
NSAIDs may cause an increased risk of serious cardiovascularthrombotic events, myocardial
infarction, and stroke,which can be fatal. This risk may increase with duration ofuse. Patients with
cardiovascular disease or risk factors forcardiovascular disease may be at greater risk (See
IBU tablets are contraindicated for treatment of peri-operativepain in the setting of coronary
artery bypass graft (CABG)surgery (See WARNINGS).
NSAIDS cause an increased risk of serious gastrointestinaladverse events including bleeding,
ulceration, and perforationof the stomach or intestines, which can be fatal. These eventscan occur
at any time during use and without warning symptoms.Elderly patients are at greater risk for
serious gastrointestinalevents. (See WARNINGS).
IBU tablets contain the active ingredient ibuprofen, which is (±) -2 - (p - isobutylphenyl) propionic acid.
Ibuprofen is a white powde rwith a melting point of 74-77° C and is very slightly soluble in water(<1
mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is
IBU, a nonsteroidal anti-inflammatory drug (NSAID), is availablein 400 mg, 600 mg, and 800 mg tablets
for oral administration.Inactive ingredients: carnauba wax, colloidal silicon dioxide,croscarmellose
sodium, hypromellose, magnesium stearate, microcrystallinecellulose, polydextrose, polyethylene
glycol, polysorbate,titanium dioxide.
IBU tablets contain ibuprofen which possesses analgesic andantipyretic activities. Its mode of action,
like that of other NSAIDs, isnot completely understood, but may be related to prostaglandin
In clinical studies in patients with rheumatoid arthritis andosteoarthritis, Ibuprofen tablets have been
shown to be comparableto aspirin in controlling pain and inflammation and to be associatedwith a
statistically significant reduction in the milder gastrointestinalside effects (see ADVERSE
REACTIONS). Ibuprofen may be well toleratedin some patients who have had gastrointestinal side
effectswith aspirin, but these patients when treated with IBU tablets shouldbe carefully followed for
signs and symptoms of gastrointestinalulceration and bleeding. Although it is not definitely known
whetheribuprofen causes less peptic ulceration than aspirin, in one studyinvolving 885 patients with
rheumatoid arthritis treated for up to oneyear, there were no reports of gastric ulceration with
ibuprofenwhereas frank ulceration was reported in 13 patients in the aspiringroup (statistically
Gastroscopic studies at varying doses show an increased tendencytoward gastric irritation at higher
doses. However, at comparabledoses, gastric irritation is approximately half that seen with
aspirin.Studies using 51Cr-tagged red cells indicate that fecal blood lossassociated with Ibuprofen
tablets in doses up to 2400 mg daily didnot exceed the normal range, and was significantly less than
thatseen in aspirin-treated patients.
In clinical studies in patients with rheumatoid arthritis, Ibuprofenhas been shown to be comparable to
indomethacin in controlling thesigns and symptoms of disease activity and to be associated with
astatistically significant reduction of the milder gastrointestinal (see ADVERSE REACTIONS) and
CNS side effects.
Ibuprofen may be used in combination with gold salts and/or corticosteroids.
Controlled studies have demonstrated that Ibuprofen is a more effective analgesic than propoxyphene
for the relief of episiotomy pain, pain following dental extraction procedures, and for the relief ofthe
symptoms of primary dysmenorrhea.
In patients with primary dysmenorrhea, Ibuprofen has been shown to reduce elevated levels of
prostaglandin activity in the menstrualfluid and to reduce resting and active intrauterine pressure, as well
asthe frequency of uterine contractions. The probable mechanism ofaction is to inhibit prostaglandin
synthesis rather than simply to provide analgesia.
The ibuprofen in IBU tablets is rapidly absorbed. Peak serum ibuprofen levels are generally attained
one to two hours after administration.With single doses up to 800 mg, a linear relationship exists
between amount of drug administered and the integrated area underthe serum drug concentration vs time
curve. Above 800 mg, however,the area under 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 similar serum ibuprofen concentration-time profiles. When Ibuprofen is administered
immediately after a meal, there is a reduction in the rate of absorption but no appreciable decrease in the
extent of absorption.The bioavailability of the drug is minimally altered by the presence of food.
A bioavailability study has shown that there was no interference with the absorption of ibuprofen when
given in conjunction with anantacid 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 2.0 hours.
Studies have shown that following ingestion of the drug, 45% to79% of the dose was recovered in the
urine within 24 hours as metabolite A (25%), (+)-2-[p-(2hydroxymethyl-propyl) phenyl] propionic acid
and metabolite B (37%), (+)-2-[p-(2carboxypropyl)phenyl]propionic acid; the percentages of free and
conjugated ibuprofen were approximately 1% and 14%, respectively.
Carefully consider the potential benefits and risks of Ibuprofentablets and other treatment options before
deciding to use Ibuprofen.Use the lowest effective dose for the shortest duration consistent
withindividual patient treatment goals (see WARNINGS).
IBU tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis.
IBU tablets are indicated for relief of mild to moderate pain.
IBU tablets are also indicated for the treatment of primary dysmenorrhea.
Controlled clinical trials to establish the safety and effectiveness of IBU tablets in children have not
IBU tablets are contraindicated in patients with known hypersensitivityto ibuprofen.
IBU tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type
reactions after taking aspirin orother NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to
NSAIDs have been reported in such patients (see WARNINGS, ANAPHYLACTOID REACTIONS,
and PRECAUTIONS, PREEXISTING ASTHMA).
IBU tablets are contraindicated for the treatment of peri-operative pain in the setting of coronary artery
bypass graft (CABG) surgery(see WARNINGS).
IBU tablets cannot be expected to substitute for corticosteroids orto treat corticosteroid insufficiency.
Abrupt discontinuation of corticosteroidsmay lead to disease exacerbation. Patients on
prolongedcorticosteroid therapy should have their therapy tapered slowly if adecision is made to
The pharmacological activity of IBU tablets in reducing fever andinflammation may diminish the utility
of these diagnostic signs indetecting complications of presumed noninfectious, painful conditions.
Borderline elevations of one or more liver tests may occur in upto 15% of patients taking NSAIDs,
including IBU tablets. These laboratoryabnormalities may progress, may remain unchanged, or maybe
transient with continuing therapy. Notable elevations of ALT orAST (approximately three or more times
the upper limit of normal)have been reported in approximately 1% of patients in clinical trialswith
NSAIDs. In addition, rare cases of severe hepatic reactions,including jaundice, fulminant hepatitis, liver
necrosis, and hepaticfailure, some of them with fatal outcomes have been reported. Apatient with
symptoms and/or signs suggesting liver dysfunction, orwith abnormal liver test values, should be
evaluated for evidence ofthe development of a more severe hepatic reaction while on therapywith IBU
tablets. If clinical signs and symptoms consistent with liverdisease develop, or if systemic
manifestations occur (e.g.,eosinophilia, rash, etc.), IBU tablets should be discontinued.
Anemia is sometimes seen in patients receiving NSAIDs, includingIBU tablets. This may be due to fluid
retention, occult or gross GIblood loss, or an incompletely described effect upon
erythropoiesis.Patients on long-term treatment with NSAIDs, including IBU tablets,should have their
hemoglobin or hematocrit checked if they exhibitany signs or symptoms of anemia.
In two postmarketing clinical studies the incidence of a decreasedhemoglobin level was greater than
previously reported. Decrease inhemoglobin of 1 gram or more was observed in 17.1% of 193patients
on 1600 mg ibuprofen daily (osteoarthritis), and in 22.8% of189 patients taking 2400 mg of ibuprofen
daily (rheumatoid arthritis).Positive stool occult blood tests and elevated serum creatinine levelswere
also observed in these studies.
NSAIDs inhibit platelet aggregation and have been shown to prolongbleeding time in some patients.
Unlike aspirin, their effect onplatelet function is quantitatively less, of shorter duration, and reversible.
Patients receiving IBU tablets who may be adversely affected byalterations in platelet function, such as
those with coagulation disordersor patients receiving anticoagulants should be carefully monitored.
Patients with asthma may have aspirin-sensitive asthma. The useof aspirin in patients with aspirin-
sensitive asthma has been associatedwith severe bronchospasm, which can be fatal. Since cross
reactivity,including bronchospasm, between aspirin and NSAIDs hasbeen reported in such aspirin-
sensitive patients, IBU tablets shouldnot be administered to patients with this form of aspirin
sensitivityand should be used with caution in patients with preexisting asthma.
Blurred and/or diminished vision, scotomata, and/or changes incolor vision have been reported. If a
patient develops such complaintswhile receiving IBU tablets, the drug should be discontinued, and
thepatient should have an ophthalmologic examination which includescentral visual fields and color
Aseptic meningitis with fever and coma has been observed on rareoccasions in patients on ibuprofen
therapy. Although it is probablymore likely to occur in patients with systemic lupus erythematosusand
related connective tissue diseases, it has been reported inpatients who do not have an underlying
chronic disease. If signs orsymptoms of meningitis develop in a patient on IBU tablets, the possibilityof
its being related to IBU tablets should be considered.
Information for Patients
Patients should be informed of the following information beforeinitiating therapy with an NSAID and
periodically during the course ofongoing therapy. Patients should also be encouraged to read
theNSAID Medication Guide that accompanies each prescription dispensed
IBU tablets like other NSAIDs, may cause serious CV side effects,such as MI or stroke, which may
result in hospitalization and evendeath. Although serious CV events can occur without
warningsymptoms, patients should be alert for the signs and symptoms ofchest pain, shortness of breath,
weakness, slurring of speech, andshould ask for medical advice when observing any indicative sign
orsymptoms. Patients should be apprised of the importance of thisfollow-up (see
IBU tablets, like other NSAIDs, can cause GI discomfort and, rarely,serious GI side effects, such as
ulcers and bleeding, which mayresult in hospitalization and even death. Although serious GI
tractulcerations and bleeding can occur without warning symptoms,patients should be alert for the signs
and symptoms of ulcerationsand bleeding, and should ask for medical advice when observingany
indicative signs or symptoms including epigastric pain, dyspepsia,melena, and hematemesis. Patients
should be apprised of theimportance of this follow-up (see WARNINGS,GASTROINTESTINAL
EFFECTS-RISK OF ULCERATION, BLEEDING AND PERFORATION).
IBU tablets, like other NSAIDs, can cause serious skin side effectssuch as exfoliative dermatitis, SJS
and TEN, which may result inhospitalization and even death. Although serious skin reactions mayoccur
without warning, patients should be alert for the signs andsymptoms of skin rash and blisters, fever, or
other signs of hypersensitivitysuch as itching, and should ask for medical advice whenobserving any
indicative sign or symptoms. Patients should beadvised to stop the drug immediately if they develop any
type ofrash and contact their physicians as soon as possible.
Patients should promptly report signs or symptoms of unexplainedweight gain or edema to their
Patients should be informed of the warning signs and symptoms ofhepatotoxicity (e.g., nausea, fatigue,
lethargy, pruritus, jaundice,right upper quadrant tenderness and “flu-like” symptoms). If theseoccur,
patients should be instructed to stop therapy and seek immediatemedical therapy.
Patients should be informed of the signs of an anaphylactoid reaction(e.g. difficulty breathing,
swelling of the face or throat). If theseoccur, patients should be instructed to seek immediate
emergencyhelp (see WARNINGS).
In late pregnancy, as with other NSAIDs, IBU tablets should beavoided because it may cause
premature closure of the ductus arteriosus.
Because serious GI tract ulcerations and bleeding can occur withoutwarning symptoms, physicians
should monitor for signs orsymptoms of GI bleeding. Patients on long-term treatment withNSAIDs
should have their CBC and chemistry profile checked periodically.If clinical signs and symptoms
consistent with liver or renaldisease develop, systemic manifestations occur (e.g., eosinophilia,rash
etc.), or abnormal liver tests persist or worsen, IBU tabletsshould be discontinued.
ACE-inhibitors:Reports suggest that NSAIDs may diminish the antihypertensiveeffect of ACE-
inhibitors. This interaction should be given considerationin patients taking NSAIDs concomitantly with
AspirinWhen IBU tablets are administered with aspirin, its protein bindingis reduced, although the
clearance of free IBU tablets is notaltered. The clinical significance of this interaction is not known;
however,as with other NSAIDs, concomitant administration of ibuprofenand aspirin is not generally
recommended because of the potential forincreased adverse effects.
Clinical studies, as well as post marketing observations, haveshown that Ibuprofen tablets can reduce
the natriuretic effect-offurosemide and thiazides in some patients. This response has beenattributed to
inhibition of renal prostaglandin synthesis. During concomitanttherapy with NSAIDs, the patient should
be observed closelyfor signs of renal failure (see PRECAUTIONS, Renal Effects), aswell as to assure
Ibuprofen produced an elevation of plasma lithium levels and areduction in renal lithium clearance in a
study of eleven normal volunteers.The mean minimum lithium concentration increased 15%and the renal
clearance of lithium was decreased by 19% during thisperiod of concomitant drug administration.This
effect has been attributed to inhibition of renal prostaglandinsynthesis by ibuprofen. Thus, when
ibuprofen and lithium are administeredconcurrently, subjects should be observed carefully for signsof
lithium toxicity. (Read circulars for lithium preparation before useof such concurrent therapy.)
NSAIDs have been reported to competitively inhibit methotrexateaccumulation in rabbit kidney slices.
This may indicate that they couldenhance the toxicity of methotrexate. Caution should be used
whenNSAIDs are administered concomitantly with methotrexate.
Several short-term controlled studies failed to show that Ibuprofentablets significantly affected
prothrombin times or a variety of otherclotting factors when administered to individuals on coumarin-
typeanticoagulants. However, because bleeding has been reported whenIBU tablets and other NSAIDs
have been administered to patients oncoumarin-type anticoagulants, the physician should be
cautiouswhen administering IBU tablets to patients on anticoagulants. Theeffects of warfarin and
NSAIDs on GI bleeding are synergistic, suchthat the users of both drugs together have a risk of serious
GI bleedinghigher than users of either drug alone.
In studies with human volunteers, co-administration of cimetidineor ranitidine with ibuprofen had no
substantive effect on ibuprofenserum concentrations.
Teratogenic effects: Pregnancy Category C
Reproductive studies conducted in rats and rabbits have notdemonstrated evidence of developmental
abnormalities. However,animal reproduction studies are not always predictive of humanresponse. There
are no adequate and well-controlled studies in pregnantwomen. Ibuprofen should be used in pregnancy
only if thepotential benefit justifies the potential risk to the fetus.
Because of the known effects of NSAIDs on the fetal cardiovascularsystem (closure of ductus
arteriosus), use during late pregnancyshould be avoided.
Labor and Delivery
In rat studies with NSAIDs, as with other drugs known to inhibitprostaglandin synthesis, an increased
incidence of dystocia, delayedparturition, and decreased pup survival occurred. The effects of
IBUtablets on labor and delivery in pregnant women are unknown.
It is not known whether this drug is excreted in human milk.Because many drugs are excreted in human-
milk and because of thepotential for serious adverse reactions in nursing infants from IBUtablets, a
decision should be made whether to discontinue nursing ordiscontinue the drug, taking into account the
importance of the drugto the mother.
Safety and effectiveness of IBU tablets in pediatric patients havenot been established.
As with any NSAIDs, caution should be exercised in treating theelderly (65 years and older).
The most frequent type of adverse reaction occurring withIbuprofen tablets is gastrointestinal. In
controlled clinical trials thepercentage of patients reporting one or more gastrointestinal
complaintsranged from 4% to 16%.
In controlled studies when Ibuprofen tablets were compared toaspirin and indomethacin in equally
effective doses, the overall incidenceof gastrointestinal complaints was about half that seen in eitherthe
aspirin- or indomethacin-treated patients.
Adverse reactions observed during controlled clinical trials at anincidence greater than 1% are listed in
the table. Those reactions listedin Column one encompass observations in approximately 3,000patients.
More than 500 of these patients were treated for periods ofat least 54 weeks.
Still other reactions occurring less frequently than 1 in 100 werereported in controlled clinical trials
and from marketing experience.These reactions have been divided into two categories: Column twoof
the table lists reactions with therapy with Ibuprofen tablets wherethe probability of a causal relationship
exists: for the reactions inColumn three, a causal relationship with Ibuprofen tablets has notbeen
Reported side effects were higher at doses of 3200 mg/day thanat doses of 2400 mg or less per day in
clinical trials of patients withrheumatoid arthritis. The increases in incidence were slight and stillwithin
the ranges reported in the table.
Approximately 11⁄2 hours after the reported ingestion of from 7 to10 Ibuprofen tablets (400 mg), a 19-
month old child weighing 12 kgwas seen in the hospital emergency room, apneic and
cyanotic,responding only to painful stimuli. This type of stimulus, however,was sufficient to induce
respiration. Oxygen and parenteral fluidswere given; a greenish-yellow fluid was aspirated from the
stomachwith no evidence to indicate the presence of ibuprofen. Two hoursafter ingestion the child’s
condition seemed stable; she still respondedonly to painful stimuli and continued to have periods of
apnea lastingfrom 5 to 10 seconds. She was admitted to intensive care andsodium bicarbonate was
administered as well as infusions of dextroseand normal saline. By four hours post-ingestion she could
bearoused easily, sit by herself and respond to spoken commands.Blood level of ibuprofen was 102.9
μg/mL approximately 81⁄2 hoursafter accidental ingestion. At 12 hours she appeared to be
In two other reported cases where children (each weighingapproximately 10 kg) accidentally, acutely
ingested approximately120 mg/kg, there were no signs of acute intoxication or late sequelae.Blood
level in one child 90 minutes after ingestion was 700 μg/mL —about 10 times the peak levels seen in
absorption-excretion studies.A 19-year old male who had taken 8,000 mg of ibuprofen over aperiod of
a few hours complained of dizziness, and nystagmus wasnoted. After hospitalization, parenteral
hydration and three days bedrest, he recovered with no reported sequelae.
In cases of acute overdosage, the stomach should be emptied byvomiting or lavage, though little drug
will likely be recovered if morethan an hour has elapsed since ingestion. Because the drug is acidicand
is excreted in the urine, it is theoretically beneficial to administeralkali and induce diuresis. In addition
to supportive measures, the useof oral activated charcoal may help to reduce the absorption
andreabsorption of Ibuprofen tablets.
Carefully consider the potential benefits and risks of IBU tabletsand other treatment options before
deciding to use IBU tablets. Usethe lowest effective dose for the shortest duration consistent
withindividual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with IBU tablets, thedose and frequency should be
adjusted to suit an individual patient’sneeds.Do not exceed 3200 mg total daily dose. If gastrointestinal
complaintsoccur, administer IBU tablets with meals or milk.
Rheumatoid arthritis and osteoarthritis, including flare-ups ofchronic disease:
Suggested Dosage: 1200 mg-3200 mg daily (400 mg, 600 mg or800 mg tid or qid). Individual patients
may show a better responseto 3200 mg daily, as compared with 2400 mg, although in well-
controlledclinical trials patients on 3200 mg did not show a better meanresponse in terms of efficacy.
Therefore, when treating patients with3200 mg/day, the physician should observe sufficient increased
clinicalbenefits to offset potential increased risk.The dose should be tailored to each patient, and may
be loweredor raised depending on the severity of symptoms either at time of initiatingdrug therapy or as
the patient responds or fails to respond.In general, patients with rheumatoid arthritis seem to require
higherdoses of IBU tablets than do patients with osteoarthritis.
The smallest dose of IBU tablets that yields acceptable controlshould be employed. A linear blood
level dose-response relationshipexists with single doses up to 800 mg (See CLINICAL
PHARMACOLOGYfor effects of food on rate of absorption).
The availability of three tablet strengths facilitates dosage adjustment.In chronic conditions, a
therapeutic response to therapy with IBU tablets is sometimes seen in a few days to a week but most
often isobserved by two weeks. After a satisfactory response has beenachieved, the patient’s dose
should be reviewed and adjusted asrequired.
Mild to moderate pain:
400 mg every 4 to 6 hours as necessaryfor relief of pain.In controlled analgesic clinical trials, doses
of Ibuprofen tabletsgreater than 400 mg were no more effective than the 400 mg dose.
For the treatment of dysmenorrhea, beginningwith the earliest onset of such pain, IBU tablets should be
given in adose of 400 mg every 4 hours as necessary for the relief of pain.
Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
(See the end of this Medication Guide for a list of prescription NSAID medicines.)
What it the most important information I should know about medicines called Non-Steroidal Anti-
Inflammatory Drugs (NSAIDs)?
NSAID medicines may increase the chance of a heart attack or stroke that can lead to death.
This chance increases:
with longer use of NSAID medicines in people who have heart disease
NSAID medicines should never be used right before or after a heart surgery called a “coronary artery
bypass graft (CABG).”
NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during
treatment. Ulcers and bleeding:
can happen without warning symptoms may cause death
The chance of a person getting an ulcer or bleeding increases with:
taking medicines called “corticosteroids” drinking alcohol and “anticoagulants”
longer use having poor health
NSAID medicines should only be used:
exactly as prescribed
for the shortest time needed
at the lowest dose possible for your treatment
What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) ?
NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical
conditions such as:
different types of arthritis
menstrual cramps and other types of short-term pain
Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID) ? Do not take an NSAID
if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine
for pain right before or after heart bypass surgery
Tell your healthcare provider:
about all of your medical conditions
about all of the medicines you take. NSAIDs and some other medicines can interact with each other
and cause serious side effects.
Keep a list of your medicines to show to your healthcare provider and pharmacist.
if you are pregnant. NSAID medicines should not be used by pregnant women late in their pregnancy.
if you are breastfeeding. Talk to your doctor.
What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?
Serious side effect Other side effect include
heart attack stomach pain
high blood pressure diarrhea
heart failure from body swelling (fluid retention) gas
kidney problems including kidney failure heartburn
bleeding and ulcers in the stomach and intestine nausea
low red blood cells (anemia) vomiting
life-threatening skin reactions dizziness
life-threatening allergic reactions
liver problems including liver failure
asthma attacks in people who have asthma
Get emergency help right away if you have any of the following symptoms:
shortness of breath or trouble breathing slurred speech
chest pain swelling of the face or throat
weakness in one part or side of your body
Stop your NSAID medicine and call your healthcare provider right away if you have any of the
nausea vomit blood
more tired or weaker than usual there is blood in your bowel movement or sticky it is black and
sticky like tar
itching skin rash or blister with fever
your skin or eyes look yellow unusual weight gain
stomach pain swelling of the arms and legs, hands and feet
These are not all the side effects with NSAID medicines. Talk to your healthcare provider or
pharmacist for more information about NSAID medicines.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-
FDA-1088.Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
Aspirin is an NSAID medicine but it does not increase the chance of a heart attack. Aspirin can cause
bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines.
Some of these NSAID medicines are sold in lower doses without a prescription (over-the-counter)
Talk to your healthcare provider before using over- the-counter NSAIDs for more than 10 days.
NSAID medicines that need a prescription
Generic Trade Name
Diclofenac Cataflam, Voltaren, Arthrotec (combined with misoprostol)
Etodolac Lodine, Lodine XL
Fenoprofen Nalfon, Nalfon 200
Ibuprofen Motrin, Tab-Profen, Vicoprofen* (combined with hydrocodone), Combunox (combined with
Indomethacin Indocin, Indocin SR, Indo-Lemmon, Indomethagan
Mefenamic Acid Ponstel
Naproxen Naprosyn, Anaprox, Anaprox DS, EC-Naprosyn, Naprelan, Naprapac (copackaged with
Tolmetin Tolectin, Tolectin DS, Tolectin 600
*Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAIDS, and is usually
used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may
increase the risk of heart attack or stroke
Product T ype
HUMAN PRESCRIPTION DRUG
Ite m Code (Source )
NDC:6 19 19 -6 21(NDC:55111-6 8 4)
Route of Administration
Active Ingredient/Active Moiety
Basis of Strength
Stre ng th
IBUPRO FEN (UNII: WK2XYI10 QM) (IBUPROFEN - UNII:WK2XYI10 QM)
8 0 0 mg
Stre ng th
PO LYDEXTRO SE (UNII: VH2XOU12IE)
CARNAUBA WAX (UNII: R12CBM0 EIZ)
SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)
CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )
HYPRO MELLO SES (UNII: 3NXW29 V3WO)
MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )
PO LYETHYLENE GLYCO LS (UNII: 3WJQ0 SDW1A)
PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)
TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)
CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)
sco re with uneven pieces
S hap e
S iz e
Marketing Start Date
Marketing End Date
NDC:6 19 19 -6 21-71
10 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct
0 8 /30 /20 16
Marke ting Cate gory
Application Numbe r or Monograph Citation
Marke ting Start Date
Marke ting End Date
ANDA0 756 8 2
0 8 /30 /20 16
DIRECT RX (079254320)
DIRECT RX (079254320)
Ad d re s s
Busine ss Ope rations
0 79 254320
re pa c k(6 19 19 -6 21)