CHILDRENS ADVIL- ibuprofen suspension 
Haleon US Holdings LLC

----------

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

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, 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

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

artificial and natural flavors, carboxymethylcellulose sodium, citric acid monohydrate, edetate disodium, 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

Additional Information

Long Lasting: Up to 8 hours of fever reduction

Great Convenience: Long duration means fewer doses needed per day.

Alcohol-Free

For most recent production information,

Visit www.Advil.com

Pfizer, Madison, NJ 07940 USA © 2019 Pfizer Inc.

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.

Packaged with Tamper-Evident bottle cap.

Do Not Use if breakable ring is separated or missing.

PRINCIPAL DISPLAY PANEL

NDC0573-1174-12

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

Same Great Flavor!
Now Dye-Free

Dye-Free

BLUE RASPBERRY

Blue Raspberry-Flavored Liquid
for ages 2-11 years

4 FL OZ (120 mL)
Alcohol-Free

PAA105480 Front Carton

Children's Advil Suspension BR Dye-Free 4 FL oz (120 mL)
CHILDRENS ADVIL 
ibuprofen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-1174
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (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)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SORBITOL (UNII: 506T60A25R)  
SUCROSE (UNII: C151H8M554)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorWHITE (Translucent) Score    
ShapeSize
FlavorRASPBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0573-1174-121 in 1 CARTON09/30/2019
1120 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02058906/27/1996
Labeler - Haleon US Holdings LLC (079944263)

Revised: 2/2024
Document Id: e78c4482-deac-46a8-8774-856e1fe5054c
Set id: 4eba2795-e826-480d-afdc-d62004e95f36
Version: 5
Effective Time: 20240208
 
Haleon US Holdings LLC