Children’s Advil Cold(ibuprofen and pseudoephedrine HCl)

CHILDRENS ADVIL COLD - ibuprofen and pseudoephedrine hydrochloride suspension 
Wyeth Consumer Healthcare

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Children’s Advil Cold
(ibuprofen and pseudoephedrine HCl)

DRUG FACTS

ACTIVE INGREDIENTS (IN EACH 5 ML TEASPOON)

Ibuprofen 100 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Pseudoephedrine HCl 15 mg

PURPOSES

Fever reducer / Pain reliever

Nasal decongestant

USES

temporarily relieves these cold, sinus and flu symptoms:

WARNINGS

Allergy alert:

Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

If an 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:

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 a doctor.

Do not use

Ask a doctor before use if the child has

Ask a doctor or pharmacist before use if the child is

When using this product

Stop use and ask a doctor if

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS

Weight (lb)Age (yrs)Dose (teaspoons)
under 24under 2 yrsdo not use
24-472-5 yrs1 teaspoon
48-956-11 yrs2 teaspoons

OTHER INFORMATION

INACTIVE INGREDIENTS

artificial flavor, carboxymethylcellulose sodium, citric acid monohydrate, edetate disodium, FD&C blue no. 1, FD&C red no. 40, glycerin, microcrystalline cellulose, polysorbate 80, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum

QUESTIONS OR COMMENTS?

Call weekdays from 9 AM to 5 PM EST at 1-800-88-ADVIL or ask your pharmacist, doctor or health care professional.

PRODUCT PACKAGING

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

Children’s Advil Cold

Ibuprofen 100 mg Fever Reducer/Pain Reliever (NSAID) per 5 mL

Pseudoephedrine HCI 15 mg Nasal Decongestant per 5 mL

Cold

IBUPROFEN

Pain Relief

Fever

Sore Throat

PSEUDOEPHEDRINE HCl

Stuffy Nose

Liquid Oral Suspension

Alcohol-Free

Grape Flavor

for ages 2-11 years

4 FL OZ (120 mL)

Important: Read all product information before using. Keep this box for important information. This product is intended for use in children ages 2 years – 11 years.

Wyeth

Wyeth Consumer Healthcare, Madison, NJ 07940

©2009 Wyeth

For most recent product information, visit www.advil.com

Packaged with Tamper-Evident bottle cap. Do Not Use if breakable ring is separated or missing.

Children's Advil Cold packaging

CHILDRENS ADVIL COLD 
ibuprofen, pseudoephedrine hcl   suspension
Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)0573-0187
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ibuprofen (ibuprofen) ibuprofen100 mg  in 5 mL
pseudoephedrine hydrochloride (pseudoephedrine ) pseudoephedrine hydrochloride15 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found
Product Characteristics
ColorPURPLE (translucent purple suspension) Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
10573-0187-201 BOTTLE In 1 CARTONcontains a BOTTLE
1120 mL In 1 BOTTLEThis package is contained within the CARTON (0573-0187-20)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02137304/18/2002

Labeler - Wyeth Consumer Healthcare (828831730)
Establishment
NameAddressID/FEIOperations
Richmond Division of Wyeth829390827MANUFACTURE, ANALYSIS
Revised: 02/2010Wyeth Consumer Healthcare