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Drug Facts
The following Structured Product Label (SPL) was submitted to the FDA by Humanwell Puracap Pharmaceuticals (wuhan) Co., Ltd for the product Ibuprofen (NDC 53345-059). 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 other, active ingredient (in each capsule), purpose, uses, warnings, allergy alert, stomach bleeding warning, heart attack and stroke warning, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Solubilized 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:
♦ temporarily reduces fever
Warnings
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.
When using this product
♦ you experience any of the following signs of stomach bleeding:
♦ you have symptoms of heart problems or stroke:
♦ pain gets worse or lasts more than 10 days
♦ fever gets worse or lasts more than 3 days
♦ redness or swelling is present in the painful area
♦ any new symptoms appear
If pregnant or breast-feeding, 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.
FD&C green #3, gelatin, polyethylene glycol, potassium hydroxide, purified water, sorbitol sorbitan solution, and white ink
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