Motrin IB Tablets and Caplets (McNeil Consumer)

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DESCRIPTION

Each MOTRIN® IB Tablet and Caplet 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
• the smallest effective dose should be used
• do not take longer than 10 days, unless directed by a doctor (see Warnings )

WARNINGS

Allergy alert:    Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

· hives · facial swelling · asthma (wheezing)

· shock · skin reddening · rash · blisters

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning:    This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if you:

• are age 60 or older
• have had stomach ulcers or bleeding problems
• take a blood thinning (anticoagulant) or steroid drug
• take other drugs containing an NSAID (aspirin, ibuprofen, naproxen, or others)
• have 3 or more alcoholic drinks every day while using this product
• take more or for a longer time than directed

Do not use

• if you have ever had an allergic reaction to any other pain reliever/fever reducer
• right before or after heart surgery

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 stomach pain
• ulcers
• bleeding problems
• high blood pressure
• heart or kidney disease
• taken a diuretic
• reached age 60 or older

Ask a doctor or pharmacist before use if you are

• taking any other drug containing an NSAID (prescription or nonprescription)
• taking a blood thinning (anticoagulant) or steroid drug
• under a doctor's care for any serious condition
• taking any other drug

When using this product

• take with food or milk if stomach upset occurs
• long term continuous use may increase the risk of heart attack or stroke

Stop use and ask a doctor if

• you feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding.
• 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 (1-800-222-1222) right away.

Other Information:

• Do not use if neck wrap or foil inner seal imprinted "Safety Seal®" is broken or missing.
• Store between 20°-25°C (68°-77°F)
• see end panel for lot number and expiration date

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.

HOW SUPPLIED

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

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