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Ibuprofen by Granules India Limited

Medically reviewed on October 14, 2016

Dosage form: tablet
Ingredients: IBUPROFEN 200mg
Labeler: Granules India Limited
NDC Code: 62207-357

Ibuprofen Tablets, 200 mg

ACTIVE INGREDIENT(S)

Ibuprofen 200mg (NSAID*)

*nonsteroidal anti-inflammatory drug

PURPOSE

Pain reliever / fever reducer

USE(S)

• temporarily relieves minor aches and pains due to:

◾headache

◾muscular aches

◾minor pain of arthritis

◾toothache

◾backache

◾the common cold

◾menstrual cramps

• temporarily reduces fever

WARNINGS

Allergy Alert:

Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin.

Symptoms may include:

  • hives
  • facial swelling
  • asthma(wheezing)
  • shock
  • skin reddening
  • rash
  • blisters

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

DO NOT USE
  • if you have ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer
  • right before or after heart surgery

ASK A DOCTOR BEFORE USE IF
  • 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

ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE

• 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

WHEN USING THIS PRODUCT
  • 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

STOP USE AND ASK DOCTOR IF
  • 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

IF PREGNANT OR BREAST-FEEDING

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.

KEEP OUT OF REACH OF CHILDREN

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

DIRECTIONS

• 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
  used.
• do not exceed 6 tablets/caplets in 24 hours, unless directed by a doctor.
children under 12 years
• ask a doctor

STORAGE

• 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

INACTIVE INGREDIENTS

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?

Contact 1-877-770-3183

Mon-Fri 9:00 AM to 4:30 PM EST

Manufactured By:

Granules India Limited

Hyderabad – 500 081, INDIA

MADE IN INDIA

Distributed By:

Granules USA, Inc.

Parsippany, NJ 07054

Toll-free: 1-877-770-3183

PRINCIPAL DISPLAY PANEL

IBUPROFEN 
ibuprofen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62207-357
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
FD&C YELLOW NO. 6 
HYPROMELLOSES 
STARCH, CORN 
POLYDEXTROSE 
POLYETHYLENE GLYCOL 
POVIDONE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize10mm
FlavorImprint CodeG;3
Contains    
Packaging
#Item CodePackage Description
1NDC:62207-357-4124 TABLET in 1 BOTTLE
2NDC:62207-357-4250 TABLET in 1 BOTTLE
3NDC:62207-357-43100 TABLET in 1 BOTTLE
4NDC:62207-357-46250 TABLET in 1 BOTTLE
5NDC:62207-357-47500 TABLET in 1 BOTTLE
6NDC:62207-357-48750 TABLET in 1 BOTTLE
7NDC:62207-357-491000 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20231211/17/2016
IBUPROFEN 
ibuprofen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62207-358
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
FD&C YELLOW NO. 6 
HYPROMELLOSES 
STARCH, CORN 
POLYDEXTROSE 
POLYETHYLENE GLYCOL 
POVIDONE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColororangeScoreno score
ShapeOVALSize14mm
FlavorImprint CodeG;3
Contains    
Packaging
#Item CodePackage Description
1NDC:62207-358-4124 TABLET in 1 BOTTLE
2NDC:62207-358-4250 TABLET in 1 BOTTLE
3NDC:62207-358-43100 TABLET in 1 BOTTLE
4NDC:62207-358-46250 TABLET in 1 BOTTLE
5NDC:62207-358-47500 TABLET in 1 BOTTLE
6NDC:62207-358-48750 TABLET in 1 BOTTLE
7NDC:62207-358-491000 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20231211/17/2016
Labeler - Granules India Limited (915000087)
Registrant - Granules India Limited (915000087)
Establishment
NameAddressID/FEIOperations
Granules India Ltd918609236manufacture(62207-357, 62207-358)

 
Granules India Limited

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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