Active Ingredient (In Each Caplet)
Ibuprofen USP, 200 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
The following Structured Product Label (SPL) was submitted to the FDA by Western Family Foods, Inc. for the product Ibuprofen (NDC 55312-216). 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 caplet), 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.
Ibuprofen USP, 200 mg (NSAID)*
*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 an 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:
ask a health professional before use. It is especially important not to use ibuprofen druing the last 3 months of pegnancy unless defintely 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)
| Adults and children 12 years and older |
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| children under 12 years |
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colloidal silicon dioxide, corn starch, dextrose monohydrate, hypromellose, iron oxide red, lactose monohydrate, lecithin, maltodextrin, povidone (K-30), pregelatinized starch, sodium carboxymethylcellulose, sodium starch glycolate, stearic acid, titanium dioxide, and triacetin
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Compare to the active ingredient in ADVIL®†
Ibuprofen Caplets
Pain Reliever/ Fever Reducer (NSAID)*
Proudly distributed by Western family foods, Inc.
PO Box 4057, Portland, OR 97208 USA
Manufactured by:
Granules India Limited
Madhapur, Hyderabad- 500 081, India.
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* Please review the disclaimer below.