Drug Facts
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 Aurohealth Llc for the product Ibuprofen (NDC 58602-801). 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 drug facts, 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.
Active ingredient (in each caplet)
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 and 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:
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.
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)
| adults and children 12 years and older |
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| children under 12 years |
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colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, stearic acid, titanium dioxide
Questions or comments?
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Distributed by:
AUROHEALTH LLC
2572 Brunswick Pike
Lawrenceville, NJ 08648
Code No.: TS/DRUGS/22/2009
Made in India
* Please review the disclaimer below.