INFANTS ADVIL- ibuprofen suspension/ drops

INFANTS ADVIL by

Drug Labeling and Warnings

INFANTS ADVIL by is a Otc medication manufactured, distributed, or labeled by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC, Pfizer Inc, PF Consumer Healthcare Canada ULC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 1.25 mL)

Ibuprofen 50 mg (NSAID)1

1 nonsteroidal anti-inflammatory drug

Purpose

Fever reducer/Pain reliever

Uses

temporarily:

• reduces fever
• relieves minor aches and pains due to the common cold, flu, 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.

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, 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 the body
  • slurred speech
  • leg swelling
• 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 with the dosing device provided. Do not use with any other device.

Dosing Chart

Weight (lb)	Age (mos)	Dose (mL)
under 6 mos		ask a doctor
12-17 lb	6-11 mos	1.25 mL
18-23 lb	12-23 mos	1.875 mL

Other Information

• 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

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

Questions or comments?

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

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

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Label

Infants'
Advil®
Concentrated Drops

Ibuprofen Oral Suspension
50 mg per 1.25 mL
Pain Reliever/Fever Reducer (NSAID)

White Grape-Flavored Drops

1/2 FL OZ (15 mL)

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

Infants'
Advil®
Concentrated Drops

Ibuprofen Oral Suspension
50 mg per 1.25 mL
Pain Reliever/Fever Reducer (NSAID)

Fever

Aches & Pains

Lasts Up To
8
Hours

Dye-Free

White Grape Flavored Drops
for ages 6–23 months

1/2 FL OZ (15 mL)
Alcohol-Free

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label

Infants'
Advil®
Concentrated Drops

Ibuprofen Oral Suspension
50 mg per 1.25 mL
Pain Reliever/Fever Reducer (NSAID)

White Grape-Flavored Drops

1 FL OZ (30 mL)

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

VALUE Size

Infants'
Advil®
Concentrated Drops

Ibuprofen Oral Suspension
50 mg per 1.25 mL
Pain Reliever/Fever Reducer (NSAID)

Fever

Aches & Pains

Lasts Up To
8
Hours

Dye-Free

White Grape Flavored Drops
for ages 6–23 months

1 FL OZ (30 mL)
Alcohol-Free

PRINCIPAL DISPLAY PANEL - 22.5 mL Bottle Label

Infants'
Advil®
Concentrated Drops

Ibuprofen Oral Suspension
50 mg per 1.25 mL
Pain Reliever/Fever Reducer (NSAID)

White Grape-Flavored Drops

3/4 FL OZ (22.5 mL)

PRINCIPAL DISPLAY PANEL - 22.5 mL Bottle Carton

50% MORE FREE

Infants'
Advil®
Concentrated Drops

Ibuprofen Oral Suspension
50 mg per 1.25 mL
Pain Reliever/Fever Reducer (NSAID)

Fever

Aches & Pains

Lasts Up To
8
Hours

Dye-Free

Alcohol-Free

White Grape Flavored Drops
for ages 6–23 months

1/2 FL OZ +
1/4 FL OZ
FREE
= 3/4 FL OZ (22.5 mL)

INGREDIENTS AND APPEARANCE

INFANTS ADVIL 
ibuprofen suspension/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0573-0191
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	50 mg  in 1.25 mL

Inactive Ingredients
Ingredient Name	Strength
ACETIC ACID (UNII: Q40Q9N063P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
SUCROSE (UNII: C151H8M554)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	WHITE (Translucent off-white)	Score
Shape		Size
Flavor	GRAPE (White grape)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0573-0191-20	1 in 1 CARTON	01/30/1998
1		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2	NDC: 0573-0191-50	1 in 1 CARTON	01/30/1998
2		30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
3	NDC: 0573-0191-22	1 in 1 CARTON	01/30/2014
3		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
4	NDC: 0573-0191-75	1 in 1 CARTON	01/30/1998
4		22.5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020812	01/30/1998

Labeler - Wyeth Consumer Healthcare LLC (828831730)

Registrant - Pfizer Inc (113480771)

Establishment
Name	Address	ID/FEI	Business Operations
PF Consumer Healthcare Canada ULC		203812479	ANALYSIS(0573-0191) , LABEL(0573-0191) , MANUFACTURE(0573-0191) , PACK(0573-0191)