Medication Guide App

Infants' motrin non-staining dye-free drops

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 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 other fever reducer/pain reliever

Ask a doctor before use if the child has

  • not been drinking fluids
  • lost a lot of fluid due to continued vomiting or diarrhea
  • stomach pain
  • problems or serious side effects from taking fever reducers or pain relievers

Ask a doctor or pharmacist before use if the child

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

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)
  • give with food or milk if stomach upset occurs

Stop use and ask a doctor if

  • an allergic reaction occurs. Seek medical help right away.
  • fever or pain gets worse or lasts more than 3 days
  • the child does not get any relief within first day (24 hours) of treatment
  • stomach pain or upset gets worse or lasts
  • 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 right away.

Other Information:    Infants', Children's and Junior Strength MOTRIN products:

  • Store at 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.

Children's MOTRIN Suspension Liquid:

  • do not use if plastic carton wrap or bottle wrap imprinted "Safety Seal" is broken or missing

Children's MOTRIN Chewable Tablets:

  • Phenylketonurics: Contains phenylalanine 1.4 mg per tablet
  • do not use if neck wrap or foil inner seal imprinted "Safety Seal" is broken or missing

Junior Strength MOTRIN Caplets and Chewable Tablets:

  • do not use if neck wrap or foil inner seal imprinted "Safety Seal" is broken or missing

Junior Strength MOTRIN Chewable Tablets:

  • phenylketonurics: contains phenylalanine 2.8 mg per tablet (tablet only)

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, glycerin, natural and artificial flavors, 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, glycerin, natural and artificial flavors, 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, natural and artificial flavors, 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, hydroxymethyl 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, hydroxymethyl 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.

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.

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.
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