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Advil Childrens

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Generic Name: ibuprofen
Dosage Form: suspension
CHILDREN’S ADVIL SUSPENSION (ibuprofen)

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 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

  • this product does not contain directions or complete warnings for adult use
  • do not give more than directed
  • do not give longer than 10 days, unless directed by a doctor (see WARNINGS)
  • 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 blue dosing cup provided. Blue 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 lb under 2 yr ask a doctor
24-35 lb 2-3 yr 1 tsp
36-47 lb 4-5 yr 1½ tsp
48-59 lb 6-8 yr 2 tsp
60-71 lb 9-10 yr 2½ tsp
72-95 lb 11 yr 3 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.


CHILDRENS ADVIL 
ibuprofen  suspension
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 0573-0174
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ibuprofen (ibuprofen) ibuprofen 100 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
No Inactive Ingredients Found
Product Characteristics
Color BLUE (Translucent, medium dark blue) Score     
Shape Size
Flavor RASPBERRY Imprint Code
Contains Sodium 10mg (Sodium 10mg)
Packaging
# NDC Package Description Multilevel Packaging
1 0573-0174-30 1 BOTTLE In 1 CARTON contains a BOTTLE
1 120 mL In 1 BOTTLE This package is contained within the CARTON (0573-0174-30)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020589 06/27/1996

CHILDRENS ADVIL 
ibuprofen  suspension
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 0573-0171
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ibuprofen (ibuprofen) ibuprofen 100 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
No Inactive Ingredients Found
Product Characteristics
Color PURPLE (Translucent purple) Score     
Shape Size
Flavor GRAPE Imprint Code
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 0573-0171-30 1 BOTTLE In 1 CARTON contains a BOTTLE
1 120 mL In 1 BOTTLE This package is contained within the CARTON (0573-0171-30)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020589 06/27/1996

CHILDRENS ADVIL 
ibuprofen  suspension
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 0573-0170
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ibuprofen (ibuprofen) ibuprofen 100 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
No Inactive Ingredients Found
Product Characteristics
Color RED (Translucent red) Score     
Shape Size
Flavor FRUIT Imprint Code
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 0573-0170-30 1 BOTTLE In 1 CARTON contains a BOTTLE
1 120 mL In 1 BOTTLE This package is contained within the CARTON (0573-0170-30)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020589 06/27/1996

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



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