CHILDRENS ADVIL- ibuprofen suspension 
Pfizer Consumer Healthcare

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DRUG FACTS

ACTIVE INGREDIENT (IN EACH 5 ML)

Ibuprofen 100 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

PURPOSE

Fever reducer/Pain reliever

USES

temporarily:

  • reduces fever
  • relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches

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 an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning:

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if the child

  • has had stomach ulcers or bleeding problems
  • takes a blood thinning (anticoagulant) or steroid drug
  • takes other drugs containing prescription or nonprescription NSAIDs [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
  • right before or after heart surgery

Ask a doctor before use if

  • stomach bleeding warning applies to the child
  • child has problems or serious side effects from taking pain relievers or fever reducers
  • child has a history of stomach problems, such as heartburn
  • child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma
  • child has not been drinking fluids
  • child has lost a lot of fluid due to vomiting or diarrhea
  • child is taking a diuretic

Ask a doctor or pharmacist before use if the child is

  • under a doctor's care for any serious condition
  • taking any other drug

When using this product

  • take with food or milk if stomach upset occurs
  • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

Stop use and ask a doctor if

  • child experiences any of the following signs of stomach bleeding:
    • feels faint
    • vomits blood
    • has bloody or black stools
    • has stomach pain that does not get better
  • the child does not get any relief within first day (24 hours) of treatment
  • fever or pain gets worse or lasts more than 3 days
  • redness or swelling is present in the painful area
  • 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.

DIRECTIONS

  • this product does not contain directions or complete warnings for adult use
  • do not give more than directed
  • shake well before using
  • find right dose on chart below. If possible, use weight to dose; otherwise use age.
  • repeat dose every 6-8 hours, if needed
  • do not use more than 4 times a day
  • measure only with the dosing cup provided. Dosing cup to be used with Children's Advil Suspension only. Do not use with other products. Dose lines account for product remaining in cup due to thickness of suspension.

Dosing Chart

Weight (lb)Age (yr)Dose (tsp)
under 24 lbunder 2 yrask a doctor
24-35 lb 2-3 yr1 tsp
36-47 lb 4-5 yr1½ tsp
48-59 lb 6-8 yr 2 tsp
60-71 lb9-10 yr2½ tsp
72-95 lb11 yr3 tsp

OTHER INFORMATION

Children's Advil Suspension Fruit Flavor; Children's Advil Suspension Grape Flavor; Children's Advil Suspension White Grape Flavor; Children's Advil Bubblegum

  • each teaspoon contains: sodium 3 mg
  • one dose lasts 6-8 hours
  • store at 20-25°C (68-77°F)
  • see bottom of box for lot number and expiration date

Children's Advil Suspension Blue Raspberry Flavor

  • each teaspoon contains: sodium 10 mg
  • one dose lasts 6-8 hours
  • store at 20-25°C (68-77°F)
  • see bottom of box for lot number and expiration date

INACTIVE INGREDIENTS

Children's Advil Suspension Fruit Flavor

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

Children's Advil Suspension Grape Flavor

acetic acid, artificial flavor, 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

Children's Advil Suspension Blue Raspberry Flavor

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

Children's Advil Suspension White Grape Flavor

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

Children's Advil Suspension Bubblegum Flavor

carboxymethylcellulose sodium, citric acid monohydrate, edetate disodium, FD&C red no. 40, glycerin, microcrystalline cellulose, natural and artificial flavor, 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

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton - Blue Raspberry-Flavored

Children's
Advil
®
Suspension

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

FEVER

Aches & Pains
Lasts Up To
8
Hours

BLUE
RASPBERRY!

Blue Raspberry–Flavored Liquid
for ages 2–11 years

4 FL OZ (120 mL)
Alcohol-Free

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton - Blue Raspberry-Flavored

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton - Grape-Flavored

Children's
Advil
®
Suspension

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

FEVER

Aches & Pains
Lasts Up To
8
Hours

Grape–Flavored Liquid
for ages 2–11 years

4 FL OZ (120 mL)
Alcohol-Free

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton - Grape-Flavored

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton - Fruit-Flavored

Children's
Advil
®
Suspension

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

FEVER

Aches & Pains
Lasts Up To
8
Hours

Fruit–Flavored Liquid
for ages 2–11 years

4 FL OZ (120 mL)

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton - Fruit-Flavored

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton - White Grape-Flavored

Children's
Advil
®
Suspension

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

FEVER

Aches & Pains
Lasts Up To
8
Hours

Dye-Free
WHITE GRAPE

White Grape–Flavored Liquid
for ages 2–11 years

4 FL OZ (120 mL)
Alcohol-Free

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton - White Grape-Flavored

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton - Bubble Gum-Flavored

NEW Flavor!

Children's
Advil
®
Suspension

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

FEVER

Aches & Pains
Lasts Up To
8
Hours

Bubble
Gum

Bubble Gum–Flavored Liquid
for ages 2–11 years

4 FL OZ (120 mL)
Alcohol-Free

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton - Bubble Gum-Flavored
CHILDRENS ADVIL 
ibuprofen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-0174
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE SODIUM 
CITRIC ACID MONOHYDRATE 
EDETATE DISODIUM 
FD&C BLUE NO. 1 
GLYCERIN 
CELLULOSE, MICROCRYSTALLINE 
POLYSORBATE 80 
SODIUM BENZOATE 
SODIUM CITRATE 
SORBITOL 
SUCROSE 
XANTHAN GUM 
WATER 
PROPYLENE GLYCOL, (R)- 
Product Characteristics
ColorBLUE (Translucent, medium dark blue) Score    
ShapeSize
FlavorRASPBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0573-0174-301 in 1 CARTON
1120 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02058906/27/1996
CHILDRENS ADVIL 
ibuprofen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-0171
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ACETIC ACID 
BUTYLATED HYDROXYTOLUENE 
CARBOXYMETHYLCELLULOSE SODIUM 
CITRIC ACID MONOHYDRATE 
EDETATE DISODIUM 
FD&C BLUE NO. 1 
GLYCERIN 
CELLULOSE, MICROCRYSTALLINE 
POLYSORBATE 80 
FD&C RED NO. 40 
WATER 
SODIUM BENZOATE 
SORBITOL 
SUCROSE 
XANTHAN GUM 
PROPYLENE GLYCOL, (R)- 
Product Characteristics
ColorPURPLE (Translucent purple) Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0573-0171-301 in 1 CARTON
1120 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02058906/27/1996
CHILDRENS ADVIL 
ibuprofen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-0170
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE SODIUM 
CITRIC ACID MONOHYDRATE 
EDETATE DISODIUM 
FD&C RED NO. 40 
GLYCERIN 
CELLULOSE, MICROCRYSTALLINE 
POLYSORBATE 80 
WATER 
SODIUM BENZOATE 
SORBITOL 
SUCROSE 
XANTHAN GUM 
Product Characteristics
ColorRED (Translucent red) Score    
ShapeSize
FlavorFRUITImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0573-0170-301 in 1 CARTON
1120 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02058906/27/1996
CHILDRENS ADVIL 
ibuprofen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-0290
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYTOLUENE 
CARBOXYMETHYLCELLULOSE SODIUM 
CITRIC ACID MONOHYDRATE 
EDETATE DISODIUM 
GLYCERIN 
CELLULOSE, MICROCRYSTALLINE 
POLYSORBATE 80 
PROPYLENE GLYCOL, (R)- 
WATER 
SODIUM BENZOATE 
SORBITOL 
SUCROSE 
XANTHAN GUM 
ACETIC ACID 
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0573-0290-301 in 1 CARTON
1120 mL in 1 BOTTLE
2NDC:0573-0290-011 in 1 CARTON
230 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02058906/28/2010
CHILDRENS ADVIL 
ibuprofen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-0207
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE SODIUM 
CITRIC ACID MONOHYDRATE 
EDETATE DISODIUM 
FD&C RED NO. 40 
GLYCERIN 
CELLULOSE, MICROCRYSTALLINE 
POLYSORBATE 80 
PROPYLENE GLYCOL, (R)- 
WATER 
SODIUM BENZOATE 
SORBITOL 
SUCROSE 
XANTHAN GUM 
Product Characteristics
ColorPINKScore    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0573-0207-301 in 1 CARTON
1120 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02058911/01/2012
Labeler - Pfizer Consumer Healthcare (828831730)
Establishment
NameAddressID/FEIBusiness Operations
Fareva Richmond, Inc.969523245ANALYSIS(0573-0207, 0573-0290, 0573-0170, 0573-0171, 0573-0174), LABEL(0573-0207, 0573-0290, 0573-0170, 0573-0171, 0573-0174), MANUFACTURE(0573-0207, 0573-0290, 0573-0170, 0573-0171, 0573-0174), PACK(0573-0207, 0573-0290, 0573-0170, 0573-0171, 0573-0174), RELABEL(0573-0207, 0573-0290, 0573-0170, 0573-0171, 0573-0174), REPACK(0573-0207, 0573-0290, 0573-0170, 0573-0171, 0573-0174)

Revised: 05/2013
 
Pfizer Consumer Healthcare