Active Ingredient(S)
Ibuprofen USP, 200mg (NSAID)*
*nonsteroidal anti-inflammatory drug
The following Structured Product Label (SPL) was submitted to the FDA by Allegiant Health for the product Ibuprofen 200mg (NDC 69168-467). 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(s), purpose, use(s), warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Ibuprofen USP, 200mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Pain Reliever/Fever reducer
temporarily relieves minor aches and
pains due to:
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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chances are 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. Contains FD&C Yellow No. 5 (tartrazine) as a color additive.
you experience any of the following signs of stomach bleeding:
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 (1-800-222-1222) right away.
Colloidal Silicon Dioxide, Croscarmellose Sodium, FD&C
Blue #2, FD&C Yellow #5, FD&C Yellow #6, Iron Oxide Red, Lecithin, Magnesium
Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol,
Pregelatinized Starch, Talc, Titanium Dioxide.
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* Please review the disclaimer below.