Active Ingredient (In Each Tablet/Caplet)
Ibuprofen 200 mg (NSAID) *
* nonsteroidal anti-inflammatory drug
The following Structured Product Label (SPL) was submitted to the FDA by Granules India Limited for the product Ibuprofen (NDC 62207-365). 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/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 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:
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 |
|
| Children under 12 years |
|
colloidal silicon dioxide, corn starch, hypromellose, iron oxide red, lactose monohydrate, povidone k30, sodium starch glycolate, stearic acid, titanium dioxide, triacetin
Call
1-877-770-3183:
weekdays 9:00 AM to 4:30 PM EST
Do not use if the foil inner seal is broken or missing
NDC# 62207-365-43
See New Warnings Information
IBUPROFEN TABLETS USP, 200 mg
Pain Reliever/Fever Reducer (NSAID)
100 Tablets**
Important: Read all product information before using.
Do not use if the foil inner seal is broken or missing
NDC# 62207-366-43
See New Warnings Information
IBUPROFEN TABLETS USP, 200 mg
Pain Reliever/Fever Reducer (NSAID)
100 Coated Caplets**
**Capsule-Shaped Tablets
Important: Read all product information before using.
* Please review the disclaimer below.