Active Ingredient (In Each Tablet)
Ibuprofen 200 mg (NSAID)*
*nonsteroidal anti- inflammatory drug
The following Structured Product Label (SPL) was submitted to the FDA by Sda Laboratories, Inc. for the product Ibuprofen (NDC 66424-396). 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 tablet), purpose, uses, warnings, allergy alert:, stomach bleeding 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.
Ibuprofen 200 mg (NSAID)*
*nonsteroidal anti- inflammatory drug
Pain Reliever/ Fever Reducer
temporarily relieves minor aches and pain 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
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). This Package for Households Without Young Children.
| adults and children 12 years and older |
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| children under 12 years |
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colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, red iron oxide, talc & titanium dioxide
*This product is not manufactured or distributed by Pfizer Consumer Products, owner of the registered trademark ADVIL®.
* Please review the disclaimer below.