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Advil Childrens

Package insert / prescribing information
Generic name: ibuprofen
Dosage form: suspension
Drug class: Nonsteroidal anti-inflammatory drugs

Medically reviewed by Drugs.com. Last updated on Jul 1, 2021.

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

Heart attack and stroke warning

NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer 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, or had a stroke
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

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
child has symptoms of heart problems or stroke:
chest pain
trouble breathing
weakness in one part or side of body
slurred speech
leg swelling
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
mL = milliliter
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 (mL)

under 24 lb

under 2 yr

ask a doctor

24-35 lb

2-3 yr

5 mL

36-47 lb

4-5 yr

7.5 mL

48-59 lb

6-8 yr

10 mL

60-71 lb

9-10 yr

12.5 mL

72-95 lb

11 yr

15 mL

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 5 mL 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; Children's Advil Suspension Sugar-Free Dye-Free Berry Flavor

each 5 mL 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 flavor, 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

Children's Advil Suspension Sugar-Free Dye-Free Berry

artificial flavor, +orbate 80, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, xanthan gum

QUESTIONS OR COMMENTS?

call toll-free 1-800-88-ADVIL or ask your pharmacist, doctor or health care professional

PRINCIPAL DISPLAY PANEL

NDC 0573-0174-30

Children's
Advil®
Suspension

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

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

NDC 0573-0171-30

Children's
Advil®
Suspension

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

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

NDC 0573-0170-30

Children's
Advil®
Suspension

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

Fever

Aches & Pains

Lasts Up To
8
Hours

Fruit-Flavored Liquid
for ages
2-11 years

4 FL OZ (120 mL)
Alcohol-Free

PRINCIPAL DISPLAY PANEL

NDC0573-0290-30

Children's
Advil®
Suspension

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

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

NDC 0573-0207-30

Children's
Advil®
Suspension

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

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

NDC 0573-0232-30

SUGAR-FREE

Children's
Advil®
Suspension

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

Fever

Aches & Pains
Lasts Up To
8
Hours

Dye-Free
BERRY

Berry-Flavored Liquid
for ages 2-11 years

4 FL OZ (120 mL)
Alcohol-Free

CHILDRENS ADVIL
ibuprofen suspension
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC: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
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
CITRIC ACID MONOHYDRATE
EDETATE DISODIUM
FD&C BLUE NO. 1
GLYCERIN
MICROCRYSTALLINE CELLULOSE
POLYSORBATE 80
PROPYLENE GLYCOL
WATER
SODIUM BENZOATE
SODIUM CITRATE, UNSPECIFIED FORM
SORBITOL
SUCROSE
XANTHAN GUM
Product Characteristics
Color BLUE (Translucent, medium dark blue) Score
Shape Size
Flavor RASPBERRY Imprint Code
Contains
Packaging
# Item Code Package Description
1 NDC:0573-0174-30 1 BOTTLE in 1 CARTON
1 120 mL in 1 BOTTLE
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 Item Code (Source) NDC: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
ACETIC ACID
BUTYLATED HYDROXYTOLUENE
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
CITRIC ACID MONOHYDRATE
EDETATE DISODIUM
FD&C BLUE NO. 1
GLYCERIN
MICROCRYSTALLINE CELLULOSE
POLYSORBATE 80
PROPYLENE GLYCOL
FD&C RED NO. 40
WATER
SODIUM BENZOATE
SORBITOL
SUCROSE
XANTHAN GUM
Product Characteristics
Color PURPLE (Translucent purple) Score
Shape Size
Flavor GRAPE Imprint Code
Contains
Packaging
# Item Code Package Description
1 NDC:0573-0171-30 1 BOTTLE in 1 CARTON
1 120 mL in 1 BOTTLE
2 NDC:0573-0171-03 1 BOTTLE in 1 CARTON
2 30 mL in 1 BOTTLE
3 NDC:0573-0171-32 2 CARTON in 1 PACKAGE
3 1 BOTTLE in 1 CARTON
3 120 mL in 1 BOTTLE
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 Item Code (Source) NDC: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
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
CITRIC ACID MONOHYDRATE
EDETATE DISODIUM
FD&C RED NO. 40
GLYCERIN
MICROCRYSTALLINE CELLULOSE
POLYSORBATE 80
WATER
SODIUM BENZOATE
SORBITOL
SUCROSE
XANTHAN GUM
Product Characteristics
Color RED (Translucent red) Score
Shape Size
Flavor FRUIT Imprint Code
Contains
Packaging
# Item Code Package Description
1 NDC:0573-0170-30 1 BOTTLE in 1 CARTON
1 120 mL in 1 BOTTLE
2 NDC:0573-0170-01 1 BOTTLE in 1 CARTON
2 30 mL in 1 BOTTLE
3 NDC:0573-0170-32 1 BOTTLE in 1 CARTON
3 120 mL in 1 BOTTLE
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 Item Code (Source) NDC:0573-0290
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
ACETIC ACID
BUTYLATED HYDROXYTOLUENE
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
CITRIC ACID MONOHYDRATE
EDETATE DISODIUM
GLYCERIN
MICROCRYSTALLINE CELLULOSE
POLYSORBATE 80
PROPYLENE GLYCOL
WATER
SODIUM BENZOATE
SORBITOL
SUCROSE
XANTHAN GUM
Product Characteristics
Color Score
Shape Size
Flavor GRAPE Imprint Code
Contains
Packaging
# Item Code Package Description
1 NDC:0573-0290-30 1 BOTTLE in 1 CARTON
1 120 mL in 1 BOTTLE
2 NDC:0573-0290-01 1 BOTTLE in 1 CARTON
2 30 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020589 12/01/2010
CHILDRENS ADVIL
ibuprofen suspension
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0207
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
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
CITRIC ACID MONOHYDRATE
EDETATE DISODIUM
FD&C RED NO. 40
GLYCERIN
MICROCRYSTALLINE CELLULOSE
POLYSORBATE 80
PROPYLENE GLYCOL
WATER
SODIUM BENZOATE
SORBITOL
SUCROSE
XANTHAN GUM
Product Characteristics
Color PINK Score
Shape Size
Flavor BUBBLE GUM Imprint Code
Contains
Packaging
# Item Code Package Description
1 NDC:0573-0207-30 1 BOTTLE in 1 CARTON
1 120 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020589 09/04/2012
CHILDRENS ADVIL
ibuprofen suspension
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0232
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
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
CITRIC ACID MONOHYDRATE
EDETATE DISODIUM
GLYCERIN
MICROCRYSTALLINE CELLULOSE
POLYSORBATE 80
PROPYLENE GLYCOL
WATER
SODIUM BENZOATE
SODIUM CITRATE, UNSPECIFIED FORM
SORBITOL
SUCRALOSE
XANTHAN GUM
Product Characteristics
Color Score
Shape Size
Flavor BERRY Imprint Code
Contains
Packaging
# Item Code Package Description
1 NDC:0573-0232-30 1 BOTTLE in 1 CARTON
1 120 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020589 12/20/2013
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

Frequently asked questions