INFANTS ADVIL CONCENTRATED DROPS - ibuprofen  suspension/ drops 
Wyeth Consumer Healthcare

----------

INFANT’S ADVIL CONCENTRATED DROPS
INFANT’S ADVIL CONCENTRATED DROPS (Dye-Free)
(Ibuprofen)

DRUG FACTS

ACTIVE INGREDIENT (IN EACH 1.25 ML)

Ibuprofen 50 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

PURPOSE

Fever reducer/Pain reliever

USES

temporarily:

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:

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

Dosing Chart

Weight (lb)Age (mos)Dose (mL)
under 6 mosask a doctor
12-17 lb 6-11 mos1.25 mL
18-23 lb 12-23 mos1.875 mL

OTHER INFORMATION

INACTIVE INGREDIENTS

Infant’s Advil Concentrated Drops White Grape (dye-free)

acetic acid, artificial flavor, butylated hydroxytoluene, carboxymethylcellulose sodium, citric acid monohydrate, edetate disodium, glycerin, microcrystalline cellulose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum

Infants Advil Concentrated Drops Grape

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

QUESTIONS OR COMMENTS?

Call toll-free 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.

Infants’ Advil Concentrated Drops

Ibuprofen, 50 mg >> Fever Reducer/Pain Reliever (NSAID)

per 1.25 mL

Fever

Aches & Pains

Lasts up to 8 Hours

Dye-Free

White Grape Flavored Drops for ages 6-23 months

1/2 FL OZ (15 mL)

Alcohol Free

Important: Read all product information before using. Keep this box for important information. This product is intended for use in children ages 6 months - 23 months.

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

Rinse the oral syringe with tap water only

Wyeth Consumer Healthcare Madison, NJ 07940 USA © 2008 Wyeth

Do Not Use if breakable ring on bottle cap is separated or missing.

Child-Resistant Safety Cap

Infants Advil White Grape Concentrated Drops Packaging

INFANTS ADVIL CONCENTRATED DROPS 
ibuprofen   suspension/ drops
Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)0573-0193
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ibuprofen (ibuprofen) ibuprofen50 mg  in 1.25 mL
Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found
Product Characteristics
ColorPURPLE (translucent purple) Score    
ShapeSize
FlavorGRAPE (grape flavor with grape odor) Imprint Code
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
10573-0193-201 BOTTLE In 1 CARTONcontains a BOTTLE, DROPPER
115 mL In 1 BOTTLE, DROPPERThis package is contained within the CARTON (0573-0193-20)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02081206/19/1998

INFANTS ADVIL CONCENTRATED DROPS 
ibuprofen   suspension/ drops
Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)0573-0191
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ibuprofen (ibuprofen) ibuprofen50 mg  in 1.25 mL
Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found
Product Characteristics
ColorWHITE (Translucent off-white) Score    
ShapeSize
FlavorGRAPE (White grape) Imprint Code
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
10573-0191-201 BOTTLE In 1 CARTONcontains a BOTTLE, DROPPER
115 mL In 1 BOTTLE, DROPPERThis package is contained within the CARTON (0573-0191-20)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02081201/30/1998

Labeler - Wyeth Consumer Healthcare (828831730)
Revised: 06/2009Wyeth Consumer Healthcare