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 Marketing Association Inc. for the product Ibuprofen (NDC 83324-210). 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:
■ hives
■ facial swelling
■ asthma (wheezing)
■ shock
■ skin reddening
■ rash
■ blisters.
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
■ are age 60 or older
■ have had stomach ulcers or bleeding problems
■ take a blood thinning (anticoagulant) or steroid drug
■ take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
■ have 3 or more alcoholic drinks every day while using this product
■ take more or for a longer time than directed
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 delivery problems in the unborn child or complications during delivery.
In case of overdose, get medical help or contact a Poison Control Center right away.
FD&C Blue #1, gelatin, polyethylene glycol,potassium hydroxide, purified water, sorbitan and sorbitol
call toll-free 1-888-235-2466
READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION
DO NOT USE IF TAMPER-EVIDENT SEAL UNDER BOTTLE CAP IMPRINTED WITH “ SEALED for YOUR PROTECTION” IS BROKEN OR MISSING.
†This product is not manufactured or distributed by the owners of Advil® LIQUI-GELS®.
Distributed by CDMA, Inc.
Novi, MI 48375
www.qualitychoice.com
Questions: 800-935-2362
R0325
L0001023
MADE IN INDIA
Code: TN/DRUGS/TN/25/00074
P3500/00/25
* Please review the disclaimer below.