DESCRIPTION

Children's MOTRIN®Cold Oral Suspensionis 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.

PRODUCT PHOTO(S):