DESCRIPTION

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.

USES

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, 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

PROFESSIONAL INFORMATION :
OVERDOSAGE INFORMATION

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.

HOW SUPPLIED

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.