CHILDRENS ADVIL  - ibuprofen suspension 
Physicians Total Care, Inc.

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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:

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 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
  • takes 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
  • right before or after heart surgery

Ask a doctor before use if the child has

  • problems or serious side effects from taking pain relievers or fever reducers
  • 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
  • asthma
  • taken a diuretic

Ask a doctor or pharmacist before use if the child is

  • taking any other drug containing an NSAID (prescription or nonprescription)
  • 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

  • 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

  • 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 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

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

  • 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

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.

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

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.

Long Lasting: Up to 8 hours of fever relief.

Great Convenience: Long duration means fewer doses needed per day.

Wyeth

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

Wyeth Consumer Healthcare

Madison, NJ 07940 USA ©2009 Wyeth

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

image of No Labeling available

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CHILDRENS ADVIL 
ibuprofen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-1552(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 
Product Characteristics
ColorRED (Translucent red) Score    
ShapeSize
FlavorFRUITImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:54868-1552-11 BOTTLE ( BOTTLE) in 1 CARTONcontains a BOTTLE
1120 mL in 1 BOTTLEThis package is contained within the CARTON (54868-1552-1)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02058911/22/199403/13/2012

Labeler - Physicians Total Care, Inc. (194123980)
Establishment
NameAddressID/FEIOperations
Physicians Total Care, Inc.194123980relabel

Revised: 03/2012 Physicians Total Care, Inc.