Active Ingridient
(in each capsule)
Solubulised 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 Big Lots Stores, Inc. for the product Ibuprofen (NDC 50594-146). 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 ingridient, purpose, uses, allergy alert, 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.
(in each capsule)
Solubulised Ibuprofen equal to 200 mg Ibuprofen (NSAID)*
(present as the free acid and potassium salt)
*nonsteroidal anti-inflammatory drug
Pain reliever/fever reducer
temporarily relieves minor aches and pains due to:
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 chance 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.
you experience any of the following signs of stomach bleeding:
you have symptoms of heart problems or stroke:
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.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away
adult and children 12 years and over:
chlidren under 12 years:
FD&C blue no. 1, FD&C yellow no. 6, gelatin, lecithin (soybean), medium-chain triglycerides, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitol sorbitan.
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* Please review the disclaimer below.