Motrin IB tablets, caplets, and gelcaps

Each MOTRIN IB Tablet, Caplet and Gelcap contains ibuprofen 200 mg.

USES

Temporarily relieves minor aches and pains due to:

· headache · muscular aches · minor pain of arthritis · toothache · backache · the common cold · menstrual cramps

Temporarily reduces fever

DIRECTIONS

· do not take more than directed

adults and children 12 years and older · take 1 tablet, caplet, or gelcap every 4 to 6 hours while symptoms persist · if pain or fever does not respond to 1 tablet, caplet or gelcap, 2 tablets, caplets or gelcaps may be used, · do not exceed 6 tablets, caplets or gelcaps in 24 hours, unless directed by a doctor · the smallest effective dose should be used children under 12 years · ask a doctor

Allergy alert:   Ibuprofen may cause a severe allergic reaction which may include:

· hives · facial swelling

· asthma (wheezing) · shock

Stomach bleeding warning:   Taking more than recommended may cause stomach bleeding.

Alcohol Warning:   If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take ibuprofen or other pain relievers/fever reducers. Ibuprofen may cause stomach bleeding.

Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer.

Ask a doctor before use if you have

• problems or serious side effects from taking pain relievers or fever reducers
• stomach problems that last or come back, such as heartburn, upset stomach, or pain
• ulcers
• bleeding problems
• high blood pressure, heart or kidney disease, are taking a diuretic, or are over 65 years of age.

Ask a doctor or pharmacist before use if you are

• under a doctor's care for any serious condition
• taking any other product that contains ibuprofen, or any other pain reliever/fever reducer
• taking a prescription drug for anticoagulation (blood thinning)
• taking any other drug

When using this product take with food or milk if stomach upset occurs.

Stop use and ask a doctor if

• an allergic reaction occurs. Seek medical help right away.
• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
• stomach pain or upset gets worse or lasts
• redness or swelling is present in the painful area
• any new symptoms appear.

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Other Information

• Do not use if neck wrap or foil inner seal imprinted "Safety Seal" is broken or missing.
• Store at 20°-25°C (68°-77°F) (applies to gelcaps only)
• avoid high humidity and excessive heat above 40°C (104°F) (applies to gelcaps only)

Professional Information:
Overdosage Information for Adult Motrin

IBUPROFEN

The toxicity of ibuprofen overdose is dependent upon the amount of drug ingested and the time elapsed since ingestion, though individual response may vary, which makes it necessary to evaluate each case individually. Although uncommon, serious toxicity and death have been reported in the medical literature with ibuprofen overdosage. The most frequently reported symptoms of ibuprofen overdose include abdominal pain, nausea, vomiting, lethargy and drowsiness. Other central nervous system symptoms include headache, tinnitus, CNS depression and seizures. Metabolic acidosis, coma, acute renal failure and apnea (primarily in very young children) may rarely occur. Cardiovascular toxicity, including hypotension, bradycardia, tachycardia and atrial fibrillation, also have been reported. The treatment of acute ibuprofen overdose is primarily supportive. Management of hypotension, acidosis and gastrointestinal bleeding may be necessary. In cases of acute overdose, the stomach should be emptied through ipecac-induced emesis or lavage. Emesis is most effective if initiated within 30 minutes of ingestion. Orally administered activated charcoal may help in reducing the absorption and reabsorption of ibuprofen. In children, the estimated amount of ibuprofen ingested per body weight may be helpful to predict the potential for development of toxicity although each case must be evaluated. Ingestion of less than 100 mg/kg is unlikely to produce toxicity. Children ingesting 100 to 200 mg/kg may be managed with induced emesis and a minimal observation time of four hours. Children ingesting 200 to 400 mg/kg of ibuprofen should have immediate gastric emptying and at least four hours observation in a health care facility. Children ingesting greater than 400 mg/kg require immediate medical referral, careful observation and appropriate supportive therapy. Ipecac-induced emesis is not recommended in overdoses greater than 400 mg/kg because of the risk of convulsions and the potential for aspiration of gastric contents. In adult patients the history of the dose reportedly ingested does not appear to be predictive of toxicity. The need for referral and follow-up must be judged by the circumstances at the time of the overdose ingestion. Symptomatic adults should be admitted to a health care facility for observation.

Our Adult MOTRIN combination products contain pseudoephedrine in addition to ibuprofen. For basic overdose information regarding pseudoephedrine, please see below. For additional emergency information, please contact your local poison control center.

PSEUDOEPHEDRINE

Symptoms from pseudoephedrine overdose consist most often of mild anxiety, tachycardia and/or mild hypertension. Symptoms usually appear within 4 to 8 hours and are transient, usually requiring no treatment.

INACTIVE INGREDIENTS

Tablets and Caplets :  carnauba wax, corn starch, FD&C Yellow #6, hypromellose, iron oxide, polydextrose, polyethylene glycol, silicon dioxide, stearic acid, titanium dioxide.

Gelcaps:   benzyl alcohol, butylparaben, castor oil, cellulose, corn starch, edetate calcium disodium, FD&C Yellow No. 6, gelatin, hypromellose, iron oxide, methylparaben, povidone, propylparaben, silicon dioxide, sodium lauryl sulfate, sodium propionate, sodium starch glycolate, titanium dioxide.

Tablets :  (orange, printed "MOTRIN IB" in black) in tamper evident packaging of 24, 50, 100, and 165.

Caplets:   (orange, printed "MOTRIN IB" in black) in tamper evident packaging of 24, 50, 100, 165, 250, 300 and

Gelcaps :  (colored orange and white, printed "MOTRIN IB" in black) in tamper evident packaging of 24, 50 and 100.

PRODUCT PHOTO(S):

NOTE: These photos can be used only for identification by shape, color, and imprint. They do not depict actual or relative size.

The product samples shown here have been supplied by the manufacturer. While every effort has been made to assure accurate reproduction, please remember that any visual identification should be considered preliminary. In cases of poisoning or suspected overdosage, the drug's identity should be verified by chemical analysis.