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Children's Motrin Cold Non-Staining Dye-Free Oral Suspension, Childrens Motrin Cold Oral Suspension (McNeil Consumer)

  • Description
  • Indications and Usage
  • Dosage and Administration
  • Warnings
  • Overdosage
  • How Supplied

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    Children's MOTRIN® Cold Oral Suspension is an alcohol-free berry, dye-free berry, or grape-flavored suspension. Each 5 mL (teaspoonful) contains the pain reliever/fever reducer ibuprofen 100 mg and the nasal decongestant pseudoephedrine HCl 15 mg.


    temporarily relieves these cold, sinus and flu symptoms:

    ·nasal and sinus congestion

    ·stuffy nose ·headache ·sore throat

    ·minor body aches and pains ·fever


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


    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 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
    • take 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 and/or nasal decongestant
    • right before or after heart surgery
    • in a child who is taking a prescription monoamine oxidase inhibitor [MAOI] (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

    Ask a doctor before use if the child has

    • problems or serious side effects from taking pain relievers, fever reducers or nasal decongestants
    • 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
    • thyroid disease
    • diabetes
    • taken a diuretic

    Ask a doctor before use if the child is

    • taking any other drug containing an NSAID (prescription or nonprescription) and/or nasal decongestant
    • 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

    • do not exceed recommended dosage
    • 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, pain or nasal congestion gets worse, or lasts for more than 3 days
    • redness or swelling is present in the painful area
    • any new symptoms appear
    • the child gets nervous, dizzy, sleepless or sleepy

    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 plastic carton wrap or bottle wrap imprinted "Safety Seal®" is broken or missing.
    • Store between 20-25°C (68-77°F)
    • see bottom of box for lot number and expiration date


    For overdosage information, please refer to pgs. ___-___.

    Inactive Ingredients:

    Berry Flavor: 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 Flavor: acesulfame potassium, citric acid, corn starch, flavors, glycerin, polysorbate 80, purified water, sodium benzoate, sucrose, xanthan gum. Grape Flavor: 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.


    Berry-flavored, pink-colored; Grape-flavored, purple-colored, and Dye-Free Berry-flavored, white-colored liquid in child resistant tamper-evident bottles of 1 fl. oz. and 4 fl. oz.

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    This page was last modified 30-JUN-07
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