Ibuprofen by Granules India Limited
Dosage form: tablet
Ingredients: IBUPROFEN 200mg
Labeler: Granules India Limited
NDC Code: 62207-357
Ibuprofen 200mg (NSAID*)
*nonsteroidal anti-inflammatory drug
Pain reliever / fever reducer
• temporarily relieves minor aches and pains due to:
◾minor pain of arthritis
◾the common cold
• temporarily reduces fever
Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin.
Symptoms may include:
- facial swelling
- skin reddening
If an allergic reaction occurs, stop use and seek medical help right away.
Stomach bleeding warning:This product contains an NSAID, which may cause stomach
bleeding. The chances is higher if you:
- are age 60 or older
- have had stomach ulcers or bleeding problems
- take a blood thinning(anticoagulant) or steroid drug
- take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
- have 3 or more alcoholic drinks every day while using this product
- take more or for a longer time than directed
- if you have ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer
- right before or after heart surgery
- you have problems or serious side effects from taking pain relievers or fever reducers
- the stomach bleeding warning applies to you
- you have a history of stomach problems, such as heartburn
- you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
- you have asthma
- you are taking a diuretic
• taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
• under a doctor's care for any serious condition
• taking any other drug
- take with food or milk if stomach upset occurs
- the risk of heart attack or stroke may increase if you use more than directed for longer than directed
- you experience any of the following signs of stomach bleeding:
- feel faint
- vomit blood
- have bloody or black stools
- have stomach pain that does not get better
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present in the painful area
- any new symptoms appear
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)
• do not take more than directed
• the smallest effective dose should be used
|adults and children
12 years and older
|• take 1 tablet/caplet every 4 to 6 hours while symptoms persist.
• if pain or fever does not respond to 1 tablet/caplet, 2 tablets/caplets may be
• do not exceed 6 tablets/caplets in 24 hours, unless directed by a doctor.
|children under 12 years
||• ask a doctor
• store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].
• do not use if foil inner seal is broken or missing.
• see end panel for lot number and expiration date
colloidal silicon dioxide, FD&C Yellow #6, hypromellose, maize starch, polydextrose, polyethylene glycol,
povidone k30, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide.
Questions or comments?
Mon-Fri 9:00 AM to 4:30 PM EST
Granules India Limited
Hyderabad – 500 081, INDIA
MADE IN INDIA
Granules USA, Inc.
Parsippany, NJ 07054
|Labeler - Granules India Limited (915000087)|
|Registrant - Granules India Limited (915000087)|
|Granules India Ltd||918609236||manufacture(62207-357, 62207-358)|
Medically reviewed on Oct 10, 2018