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 Top Care (topco Associates Llc) for the product Ibuprofen (NDC 36800-749). 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 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.
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
gelatin, medium-chain triglycerides, polyethylene glycol, potassium hydroxide, purified water, sorbitan solution, sorbitol, white ink
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COMPARE TO MOTRIN® IB LIQUID GELS ACTIVE INGREDIENT†
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 AN DPRODUCT INFORMATION.
†This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Motrin®IB Liquid Gels.
DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007
©TOPCO PLVA0318
* Please review the disclaimer below.