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

Uses: Children's MOTRIN® Cold Oral Suspension: temporarily relieves these cold, sinus and flu symptoms: ·nasal and sinus congestion ·stuffy nose ·headache ·sore throat ·minor body aches and pains ·fever

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 a 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
in a child who is taking a prescription monoamine oxidase inhibitor [MAOI] (certain drugs for depression, psychiatric or emotional conditions, or Parkinson' 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:

not been drinking fluids
lost a lot of fluid due to continued vomiting or diarrhea
problems or serious side effects from taking pain relievers, fever reducers or nasal decongestants
stomach pain
heart disease
high blood pressure
thyroid disease
diabetes

Ask a doctor or pharmacist before use if the child is:

under a doctor' care for any continuing medical condition
taking any other drug
taking any other product that contains ibuprofen or pseudoephedrine
taking any other pain reliever/fever reducer and/or nasal decongestant

When using this product:

do not exceed recommended dosage
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.
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
stomach pain or upset gets worse or lasts
symptoms continue or get worse
redness or swelling is present in the painful area
the child gets nervous, dizzy, sleepless or sleepy
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:

do not use if plastic carton wrap or bottle wrap imprinted "Safety Seal®" is broken or missing.
Store at 20-25°C (68-77°F)

Professional Information:

Overdosage Information

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

Inactive Ingredients: Children's MOTRIN® Cold Oral Suspension: 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.

Children's MOTRIN® Cold Oral Suspension: 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.

How Supplied: Berry-flavored, orange-colored and grape-flavored, purple-colored liquid in tamper evident bottles of 4 fl. oz.

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.