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Advil Infants Concentrated Drops

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

Medically reviewed by Drugs.com. Last updated on Nov 1, 2020.

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

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

INFANTS ADVIL
ibuprofen suspension/ drops
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0191
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (IBUPROFEN) IBUPROFEN 50 mg in 1.25 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 WHITE (Translucent off-white) Score
Shape Size
Flavor GRAPE (White grape) Imprint Code
Contains
Packaging
# Item Code Package Description
1 NDC:0573-0191-20 1 BOTTLE, DROPPER in 1 CARTON
1 15 mL in 1 BOTTLE, DROPPER
2 NDC:0573-0191-50 1 BOTTLE, DROPPER in 1 CARTON
2 30 mL in 1 BOTTLE, DROPPER
3 NDC:0573-0191-22 1 BOTTLE, DROPPER in 1 CARTON
3 15 mL in 1 BOTTLE, DROPPER
4 NDC:0573-0191-75 1 BOTTLE, DROPPER in 1 CARTON
4 22.5 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020812 01/30/1998
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
Registrant - Pfizer Inc (113480771)
Establishment
Name Address ID/FEI Operations
PF Consumer Healthcare Canada ULC 203812479 ANALYSIS(0573-0191), LABEL(0573-0191), MANUFACTURE(0573-0191), PACK(0573-0191)
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

Frequently asked questions