Children's Motrin Non-Staining Dye-Free Oral Suspension, Infants Motrin Concentrated Drops, Infants Motrin Non-Staining Dye-Free Drops, Junior Strength Motrin Caplets and Chewable Tablets, Childrens Motrin Oral Suspension and Chewable Tablets (McNeil Consumer)

Menu

DESCRIPTION

Infants' MOTRIN® Concentrated Drops are available in an alcohol-free, berry-flavored suspension and a non-staining, dye-free, berry-flavored suspension. Each 1.25 mL contains ibuprofen 50 mg. Children's MOTRIN® Oral Suspension is available as an alcohol-free, berry, dye-free berry, bubblegum or grape-flavored suspension. Each 5 mL (teaspoon) of Children's MOTRIN® Oral Suspension contains ibuprofen 100 mg. Each Children's MOTRIN® Chewable Tablet contains 50 mg of ibuprofen and is available as orange or grape-flavored chewable tablets. 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:

• reduces fever
• relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches

DIRECTIONS

See Table 2: Children's Motrin Dosing Chart on pg. __

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 the child:

• has had stomach ulcers or bleeding problems
• takes a blood thinning (anticoagulant) or steroid drug
• takes other drugs containing an NSAID (aspirin, ibuprofen, naproxen, or others)
• takes more or for a longer time than directed

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 other pain reliever/fever reducer
• night before or after heart surgery

Ask a doctor before use if the child has

• 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
• not been drinking fluids
• lost a lot of fluid due to vomiting or diarrhea
• high blood pressure
• heart or kidney disease
• taken a diuretic

Ask a doctor or pharmacist before use if the child is

• taking any other drug containg 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

• mouth or throat burning may occur; give with food or water ( children's MOTRIN ® Chewable Tablets and Junior Strength MOTRIN ® Chewable Tablets only)
• 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

• the child feels faint, vomits blood, or has bloody or black stools. These are signs of stomach bleeding.
• stomach pain or upset gets worse or lasts
• the child does not get any relief within first day (24 hours) of treatment
• fever or pain gets worse or lasts more than 3 days
• redness or swelling is present in the painful area
• any new symptoms appear

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:    Infants', Children's and Junior Strength MOTRIN® products:

• Store between 20-25°C (68-77°F)

Infants' MOTRIN® Concentrated Drops:

• do not use if plastic carton wrap or bottle wrap imprinted "Safety Seal®" and "Use with Enclosed Dosage Device" is broken or missing.
• see bottom of box for lot number and expiration date

Children's MOTRIN® Suspension Liquid:

• each teaspoon contains: sodium 2 mg
• do not use if plastic carton wrap or bottle wrap imprinted "Safety Seal®" is broken or missing
• see bottom panel for lot number and expiration date

Children's MOTRIN® Chewable Tablets:

• Phenylketonurics: Contains phenylalanine 1.4 mg per tablet
• each tablet contains: sodium 1 mg; potassium 1 mg
• do not use if neck wrap or foil inner seal imprinted "Safety Seal®" is broken or missing
• see end panel for lot number and expiration date

Junior Strength MOTRIN® Caplets and Chewable Tablets:

• do not use if neck wrap or foil inner seal imprinted "Safety Seal®" is broken or missing
• see end panel for lot number and expiration date

Junior Strength MOTRIN® Chewable Tablets:

• phenylketonurics: contains phenylalanine 2.8 mg per tablet
• see end panel for lot and expiration date

PROFESSIONAL INFORMATION :
OVERDOSAGE INFORMATION FOR ALL INFANTS', CHILDREN'S & JUNIOR STRENGTH MOTRIN® PRODUCTS

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 Children's MOTRIN® Cold products contain pseudoephedrine in addition to ibuprofen. The following is basic overdose information regarding pseudoephedrine.

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

For additional emergency information, please contact your local poison control center.

Inactive Ingredients:

Infants' MOTRIN® Concentrated Drops:

Berry-Flavored:    citric acid, corn starch, FD&C Red #40, flavors, glycerin, polysorbate 80, purified water, sodium benzoate, sorbitol, sucrose, xanthan gum. Dye-Free Berry-Flavored: artificial flavors, citric acid, corn starch, glycerin, polysorbate 80, purified water, sodium benzoate, sorbitol, sucrose, xanthan gum.

Children's MOTRIN® Oral Suspension:    Berry-Flavored: acesulfame potassium, citric acid, corn starch, D&C Yellow #10, FD&C Red #40, flavors, glycerin, polysorbate 80, purified water, sodium benzoate, sucrose, xanthan gum. Dye-Free Berry-Flavored: acesulfame potassium, citric acid, corn starch, glycerin, natural and artificial flavors, polysorbate 80, purified water, sodium benzoate, sucrose, xanthan gum. Bubble Gum-Flavored: acesulfame potassium, citric acid, corn starch, FD&C Red #40, flavors, glycerin, polysorbate 80, purified water, sodium benzoate, sucrose, xanthan gum. Grape-Flavored: acesulfame potassium, citric acid, corn starch, D&C Red #33, FD&C Blue #1, FD&C Red #40, flavors, glycerin, polysorbate 80, purified water, sodium benzoate, sucrose, xanthan gum.

Children's MOTRIN® Chewable Tablets:    Orange-Flavored: acesulfame K, aspartame, cellulose, citric acid, FD&C Yellow #6, flavor, fumaric acid, hydroxyethyl cellulose, hypromellose, magnesium stearate, mannitol, povidone, sodium lauryl sulfate, sodium starch glycolate. Grape-Flavored: acesulfame K, aspartame, cellulose, citric acid, D&C Red #7, D&C Red #30, FD&C Blue #1, flavor, fumaric acid, hydroxyethyl cellulose, hypromellose, magnesium stearate, mannitol, povidone, sodium lauryl sulfate, sodium starch glycolate.

Junior Strength MOTRIN® Chewable Tablets:    Orange-Flavored: acesulfame K, aspartame, cellulose, citric acid, FD&C yellow #6, flavor, fumaric acid, hydroxyethyl cellulose, hypromellose, magnesium stearate, mannitol, povidone, sodium lauryl sulfate, sodium starch glycolate. Grape-Flavored: acesulfame K, aspartame, cellulose, citric acid, D&C Red #7, D&C Red #30, FD&C Blue #1, flavor, fumaric acid, hydroxyethyl cellulose, hypromellose, magnesium stearate, mannitol, povidone, sodium lauryl sulfate, sodium starch glycolate. Easy-To-Swallow Caplets: carnauba wax, cellulose, corn starch, D&C Yellow #10, FD&C Yellow #6, hypromellose, polydextrose, polyethylene glycol, propylene glycol, silicon dioxide, sodium starch glycolate, titanium dioxide, triacetin.

HOW SUPPLIED

Infants' MOTRIN® Concentrated Drops:    Berry-flavored, pink-colored liquid and Berry-Flavored, Dye-Free, white-colored liquid in ½ fl. oz. bottles w/calibrated plastic syringe. Dye-Free Berry also available in 1 oz. size

Children's MOTRIN® Oral Suspension:    Berry-flavored, pink-colored; (2 and 4 fl. oz) Berry-Flavored, Dye-Free white-colored, Bubble Gum-flavored, pink-colored and Grape-flavored, purple-colored liquid in tamper evident bottles (4 fl. oz.)

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

Junior Strength MOTRIN® Chewable Tablets:    Orange-flavored, orange-colored chewable tablets or Grape-flavored, purple-colored chewable tablets in 24 count bottles.

Junior Strength MOTRIN® Caplets:    Easy-to-swallow caplets (capsule shaped tablets) in 24 count bottles.

• Post a comment
• Share this