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 Dr. Reddy's Laboratories Inc. for the product Ibuprofen (NDC 75907-428). 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), purposes, 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 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 at 20 weeks or later in 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, iron oxide red, maize starch, polyethylene glycol, povidone k-30, pregelatinized starch, sodium starch glycolate, stearic acid, talc, titanium dioxide
call 1-888-375-3784 weekdays (8 AM to 8 PM EST)
Distributed by:
Dr. Reddy’s Laboratories Inc.,
Princeton, NJ 08540
MADE IN INDIA
Rev: 06/26
**This product is not manufactured or distributed by Haleon US Holdings LLC, owner of the registered trademark Advil®.
NDC 75907-428-05
Ibuprofen Tablets USP, 200 mg
Pain Reliever / Fever Reducer (NSAID)*
Contains no ingredient made from a
gluten-containing grain (wheat, barley, or rye)
500 Coated Tablets
IMPORTANT: READ THE DIRECTIONS AND WARNINGS BEFORE USE
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
* Please review the disclaimer below.