Active Ingredient (In Each 5 Ml)
Ibuprofen 100 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
The following Structured Product Label (SPL) was submitted to the FDA by Haleon Us Holdings Llc for the product Childrens Advil (NDC 0573-1174). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each 5 ml), purpose, uses, allergy alert:, stomach bleeding warning:, heart attack and stroke warning:, sore throat warning:, do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Ibuprofen 100 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Fever reducer/Pain reliever
temporarily:
Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
If an allergic reaction occurs, stop use and seek medical help right away.
This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if the child
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.
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.
In case of overdose, get medical help or contact a Poison Control Center right away.
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 |
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
call toll-free 1-800-88-ADVIL or ask your pharmacist, doctor or health care professional
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.
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
* Please review the disclaimer below.