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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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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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