Children's MOTRIN® Ibuprofen Oral Suspension is an alcohol-free, berry, bubblegum or grape-flavored suspension. Each 5 mL (teaspoon) of Children's MOTRIN® Ibuprofen Oral Suspension contains ibuprofen 100 mg. Each Children's MOTRIN® Ibuprofen Chewable Tablet contains 50 mg of ibuprofen and are available as orange or grape-flavored chewable tablets.

USES

Children's MOTRIN® Ibuprofen Oral Suspension and Children's MOTRIN® Ibuprofen Chewable Tablets: Temporarily:

DIRECTIONS

Do not take/chew more than directed. If needed, repeat dose every 6-8 hours . Do not use more than 4 times a day. If possible, use weight to dose; otherwise use age. If stomach upset occurs while taking this product, give with food or milk. Children's MOTRIN® Ibuprofen Oral Suspension: Shake well before using. Only use enclosed measuring cup. Replace bottle cap tightly to maintain child resistance. 2-3 years (24-35 lbs): 1 tsp; 4-5 years (36-47 lbs): 1 1 / 2 tsp; 6-8 years (48-59 lbs): 2 tsp; 9-10 years (60-71 lbs): 2 1 / 2 tsp; 11 years (72-95 lbs): 3 tsp. Under 2 years (under 24 lbs), consult a physician. Children's MOTRIN® Ibuprofen Chewable Tablets: 2-3 years (24-35 lbs): 2 tablets; 4-5 years (36-47 lbs): 3 tablets; 6-8 years (48-59 lbs): 4 tablets; 9-10 years (60-71 lbs): 5 tablets; 11 years (72-95 lbs): 6 tablets. Under 2 years (under 24 lbs), call a doctor.

Children's MOTRIN® Ibuprofen Oral Suspension:

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

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

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

Stop use and ask a doctor if an allergic reaction occurs. Seek medical help right away.

Call Your Doctor If:

Do Not Use:

Keep this and all drugs out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately

Children's MOTRIN® Ibuprofen Chewable 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 the child is

When using this product

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.

OTHER INFORMATION

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.

INACTIVE INGREDIENTS

Children's MOTRIN® Berry-Flavored Ibuprofen Oral Suspension: Acesulfame potassium, citric acid, cornstarch, D&C Yellow #10, FD&C Red #40, glycerin, natural and artificial flavors polysorbate 80, purified water, sodium benzoate, sucrose, xanthan gum.

Children's MOTRIN® Bubble Gum-Flavored Ibuprofen Oral Suspension: Acesulfame potassium, citric acid, cornstarch, FD&C Red #40, natural and artificial flavors, glycerin, polysorbate 80, purified water, sodium benzoate, sucrose, xanthan gum.

Children's MOTRIN® Grape-Flavored Ibuprofen Oral Suspension: Acesulfame potassium, citric acid, cornstarch, D&C Red #33, FD&C Blue #1, FD&C Red #40, natural and artificial flavors, glycerin, polysorbate 80, purified water, sodium benzoate, sucrose, xanthan gum.

Children's MOTRIN® Ibuprofen Orange-Flavored Chewable 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.

Children's MOTRIN® Grape-Flavored Chewable Tablets: acesulfame K, aspartame, cellulose, citric acid, D&C red #7, red #30, FD&C blue #1, flavor, fumaric acid, hydroxyethyl cellulose, hydroxypropyl methylcellulose, magnesium stearate, mannitol, povidone, sodium lauryl sulfate, sodium starch glycolate.

HOW SUPPLIED

Children's MOTRIN® Ibuprofen Oral Suspension: Berry-flavored, orange-colored; Bubble Gum flavored, pink-colored and Grape-flavored, purple-colored liquid in tamper evident bottles of 2 and 4 fl. oz. Store between 20-25°C (68°-77°F).

Children's MOTRIN® Ibuprofen Chewable Tablets: Orange-flavored, orange-colored, and Grape-flavored, purple-colored, chewable tablets in 24 count bottles.

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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