Other
Drug Facts
The following Structured Product Label (SPL) was submitted to the FDA by Kenvue Brands Llc for the product Motrin Ib Migraine (NDC 50580-120). 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 capsule), purpose, use, allergy alert, stomach bleeding warning, heart attack and stroke warning, medication overuse headache warning, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)
nonsteroidal anti-inflammatory drug
(present as the free acid and potassium salt)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.
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. (1-800-222-1222)
| adults |
|
| under 18 years of age |
|
gelatin, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitan and sorbitol
call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)
* Please review the disclaimer below.