Junior Strength MOTRIN® Chewable Tablets and Junior Strength MOTRIN® Caplets contain ibuprofen 100 mg. Junior Strength MOTRIN® Chewable Tablets are available in orange or grape flavors. Junior Strength MOTRIN® Caplets are available as easy-to-swallow caplets (capsule shaped tablet).

USES

temporarily:

DIRECTIONS

Dosing

Under 6 yrs (under 48 lbs): call a doctor; 6-8 yrs (48-59 lbs): 2 tablets; 9-10 yrs (60-71 lbs): 2 1 / 2 tablets; 11 yrs (72-95 lbs): 3 tablets

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

· hives  ·facial swelling
· asthma (wheezing)  ·shock

Sore throat warning:   severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by doctor.

Do not use if the child has ever had an allergic reaction to any pain reliever/fever reducer

Ask a doctor before use if the child has

Ask a doctor or pharmacist before use if child is

Junior Strength MOTRIN® Chewable Tablets

When using this product mouth or throat burning may occur; give with food or water

Junior Strength MOTRIN® Caplets:

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

Stop use and ask a doctor if

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

Junior Strength MOTRIN® Chewable Tablets

INACTIVE INGREDIENTS

Orange-flavored tablets:   acesulfame K, aspartame, cellulose, citric acid, FD&C yellow #6, flavor, fumaric acid, hydroxyethyl cellulose, hydroxypropyl methylcellulose, magnesium stearate, mannitol, povidone, sodium lauryl sulfate, sodium starch glycolate

Grape-flavored tablets:   acesulfame K, aspartame, cellulose, citric acid, D&C red #7, D&C red #30, FD&C blue #1, flavor, fumaric acid, hydroxyethyl cellulose, hydroxypropyl methylcellulose, magnesium stearate, mannitol, povidone, sodium lauryl sulfate, sodium starch glycolate

Easy-To-Swallow Caplets:   carnauba wax, corn starch, D&C Yellow #10, FD&C Yellow #6, hydroxypropyl methylcellulose, microcrystalline cellulose, polydextrose, polyethylene glycol, propylene glycol, silicon dioxide, sodium starch glycolate, titanium dioxide, triacetin

HOW SUPPLIED

Junior Strength MOTRIN® Chewable Tablets are available as orange-flavored, orange-colored chewable tablets or grape-flavored, purple-colored chewable tablets in 24-count bottles. Store at 20-25°C (68-77°F).

Junior Strength MOTRIN® Caplets are available as easy-to-swallow caplets (capsule shaped tablets) in 24-count bottles. Store at 20-25°C (68-77°F).

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 and reproduced in full color by PDR as a quick-reference identification aid. 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' identity should be verified by chemical analysis.

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PROFESSIONAL INFORMATION

OVERDOSAGE INFORMATION

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.