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 Topco Associates Llc for the product Topcare Ibuprofen (NDC 36800-705). 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).
ammonium hydroxide, caprylic and capric acid triglycerides, FD&C green No. 3, gelatin, isopropyl alcohol, lecithin, macrogol/PEG 400, polyethylene glycol, polyvinyl acetate phthalate, potassium hydroxide, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide
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COMPARE TO ADVIL® LIQUI-GELS® minis ACTIVE INGREDIENT
Ibuprofen Liquid Gels†, 200 mg
SOLUBILIZED IBUPROFEN CAPSULES, 200 mg
PAIN RELIEVER • FEVER REDUCER (NSAID)
actual size
• Smaller capsule
• Same strength
160 mini LIQUID GELS†
minis
†LIQUID FILLED CAPSULES
* Please review the disclaimer below.