Active Ingredient (In Each Tablet)
Ibuprofen 200 mg (NSAID)*
The following Structured Product Label (SPL) was submitted to the FDA by Cvs for the product Ibuprofen (NDC 51316-365). 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), purposes, uses, warnings, stomach bleeding warning:, heart attack and stroke warning:, do not use, ask a doctor before use if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Ibuprofen 200 mg (NSAID)*
Pain reliever/ fever reducer
Allergy alert: 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 chances 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
take with food or milk if stomach upset occurs
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. (1-800-222-1222)
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