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Drug Facts
The following Structured Product Label (SPL) was submitted to the FDA by Haleon Us Holdings Llc for the product Advil Menstrual Pain (NDC 0573-0230). 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 other, active ingredient (in each tablet), purpose, uses, allergy alert, stomach bleeding warning, heart attack and stroke warning, do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Ibuprofen 200 mg (provided as ibuprofen sodium 256 mg) (NSAID)
nonsteroidal anti-inflammatory drug
Pain reliever/Fever reducer
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 you:
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.
If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
acesulfame potassium, caramel color, carnauba wax, colloidal silicon dioxide, copovidone, ferric oxide, hypromellose, mannitol, medium-chain triglycerides, microcrystalline cellulose, natural and artificial flavor, pharmaceutical ink, polyethylene glycol, propylene glycol, sodium lauryl sulfate, sucralose, titanium dioxide
Call weekdays 9 AM to 5 PM EST at 1-800-88-ADVIL
For most recent product information, visit www.Advil.com
Advil®
menstrual
PAIN
Ibuprofen Tablets, 200 mg
(Provided as Ibuprofen Sodium 256 mg)
Pain Reliever / Fever Reducer (NSAID)
READ AND KEEP CARTON
FOR COMPLETE WARNINGS
AND INFORMATION
40
Tablets
FILM-COATED
IBUPROFEN
SODIUM
Advil®
menstrual
PAIN
Ibuprofen Tablets, 200 mg
(Provided as Ibuprofen Sodium 256 mg)
Pain Reliever / Fever Reducer (NSAID)
Tablets
40 Tablets
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