Active Ingredient (In Each Tablet)
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 Junior Strength Advil (NDC 0573-0175). 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 tablet), 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.
| Weight (lb) | Age (yr) | Dose (tablets) |
|---|---|---|
| under 48 lb | under 6 yr | ask a doctor |
| 48-71 lb | 6-10 yr | 2 tablets |
| 72-95 lb | 11 yr | 3 tablets |
acetylated monoglycerides, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, methylparaben, microcrystalline cellulose, pharmaceutical glaze, pharmaceutical ink, povidone, pregelatinized starch, propylparaben, sodium benzoate, stearic acid, sucrose, synthetic iron oxides, titanium dioxide
call toll free 1-800-88-ADVIL or ask your pharmacist, doctor or health care professional
Ages 6-11
Junior Strength
Advil®
Ibuprofen Tablets, 100 mg
Pain Reliever/Fever Reducer (NSAID)
24 Coated Tablets
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WARNINGS AND INFORMATION
* Please review the disclaimer below.