Active Ingredient (In Each 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 Chain Drug Consortium, Llc for the product Ibuprofen (NDC 68016-813). 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 capsule), purpose, uses, warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if you are, when using this product, 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/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.
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
Heart attack and stroke warning: 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.
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 (1-800-222-1222) right away.
FD&C green #3, gelatin, medium-chain triglycerides, polyethylene glycol, potassium hydroxide, purified water, sorbitol sorbitan solution, white ink
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
†COMPARE TO THE ACTIVE INGREDIENT IN ADVIL® LIQUI-GELS®
Ibuprofen capsules 200 mg
Solubilized Ibuprofen Capsules, 200 mg
PAIN RELIEVER/FEVER REDUCER (NSAID)*
SOFTGELS**
(**LIQUID-FILLED CAPSULES)
TAMPER-EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
†This product is not manufactured or distributed by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC, distributor of Advil® Liqui-Gels®.
Distributed by: Pharmacy Value Alliance, LLC
407 East Lancaster Avenue,
Wayne, PA 19087
* Please review the disclaimer below.