CHILDRENS ADVIL

Pfizer Consumer Healthcare

CHILDREN'S ADVIL SUSPENSION (ibuprofen)

FULL PRESCRIBING INFORMATION: CONTENTS*

• DRUG FACTS
• ACTIVE INGREDIENT (IN EACH 5 ML)
• PURPOSE
• USES
• WARNINGS
  • Allergy alert:
  • Stomach bleeding warning:
  • Sore throat warning:
  • Do not use
  • Ask a doctor before use if
  • 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.
• DIRECTIONS
• OTHER INFORMATION
• INACTIVE INGREDIENTS
  • Children's Advil Suspension White Grape Flavor
  • Children's Advil Suspension Bubblegum Flavor
  • Children's Advil Suspension Sugar-Free Dye-Free Berry
• QUESTIONS OR COMMENTS?
• PRINCIPAL DISPLAY PANEL - 120 mL Bottle Label - Blue Raspberry-Flavored
• PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton - Blue Raspberry-Flavored
• PRINCIPAL DISPLAY PANEL - 120 mL Bottle Label - Grape-Flavored
• PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton - Grape-Flavored
• PRINCIPAL DISPLAY PANEL - 120 mL Bottle Label - Fruit-Flavored
• PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton - Fruit-Flavored
• PRINCIPAL DISPLAY PANEL - 120 mL Bottle Label - White Grape-Flavored
• PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton - White Grape-Flavored
• PRINCIPAL DISPLAY PANEL - 120 mL Bottle Label - Bubble Gum-Flavored
• PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton - Bubble Gum-Flavored
• PRINCIPAL DISPLAY PANEL - 120 mL Bottle Label - Berry-Flavored
• PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton - Berry-Flavored

FULL PRESCRIBING INFORMATION

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 directe d
• 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

OTHER INFORMATION

• 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

• 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

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

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

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, carboxymethylcellulose sodium, citric acid monohydrate, edetate disodium, glycerin, microcrystalline cellulose, polysorbate 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 - 120 mL Bottle Label - Blue Raspberry-Flavored

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

Children's
Advil ^®
Suspension

Fever Reducer / Pain Reliever (NSAID)

Active ingredient (in each 5 mL) ..........................Ibuprofen 100 mg

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

Blue Raspberry-Flavored Liquid
4 FL OZ (120 mL)

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 Label - Grape-Flavored

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

Children's
Advil ^®
Suspension

Fever Reducer / Pain Reliever (NSAID)

Active ingredient (in each 5 mL) .............Ibuprofen 100 mg

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

Grape-Flavored Liquid
4 FL OZ (120 mL)

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 Label - Fruit-Flavored

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

Children's
Advil ^®
Suspension

Fever Reducer/Pain Reliever (NSAID)

Fruit-Flavored Liquid
4 FL OZ (120 mL)

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)
Alcohol-Free

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

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

Children's
Advil ^®
Suspension

Fever Reducer / Pain Reliever (NSAID)

Active ingredient (in each 5 mL)................................. Ibuprofen 100 mg

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

White Grape-Flavored Liquid
4 FL OZ (120 mL)

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 Label - Bubble Gum-Flavored

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

Children's
Advil ^®
Suspension

Fever Reducer / Pain Reliever (NSAID)

Active ingredient (in each 5 mL).............Ibuprofen 100 mg

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

Bubble Gum-Flavored Liquid
4 FL OZ (120 mL)

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

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 Label - Berry-Flavored

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

Children's
Advil ^®
Suspension

Fever Reducer / Pain Reliever (NSAID)

Active ingredient (in each 5 mL).............Ibuprofen 100 mg

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

Sugar-Free Dye-Free
Berry-Flavored Liquid

4 FL OZ (120 mL)

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

SUGAR - FREE

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
BERRY

Berry-Flavored Liquid
for ages 2-11 years

4 FL OZ (120 mL)
Alcohol-Free