Active Ingredient (In Each Brown Oval Capsule)
Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*
(present as the free acid and potassium salt)
*nonsteroidal anti-inflammatory drug
The following Structured Product Label (SPL) was submitted to the FDA by Haleon Us Holdings Llc for the product Advil Migraine (NDC 0573-0168). 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 brown oval capsule), purpose, use, allergy alert:, stomach bleeding warning:, heart attack and stroke warning:, medication overuse headache warning:, do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*
(present as the free acid and potassium salt)
*nonsteroidal anti-inflammatory drug
Pain reliever
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.
Headaches may worsen if this product is used for 10 or more days per month.
ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
In case of overdose, get medical help or contact a Poison Control Center right away.
D&C yellow no. 10, FD&C green no. 3, FD&C red no. 40, gelatin, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitol sorbitan solution
Call toll-free 1-800-88-ADVIL
READ AND KEEP CARTON FOR COMPLETEWARNINGS AND INFORMATION
Do Not Use if seal under bottle cap imprinted with “SEALED for YOUR PROTECTION” is broken or missing.
Advil
MIGRAINE
Solubilized Ibuprofen Capsules, 200 mg
Pain Reliever
(NSAID)
Actual Size
20
Liquid Filled
Capsules
* Please review the disclaimer below.