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Ibuprofen by Granules India Limited

Medically reviewed on May 1, 2018

Dosage form: tablet
Ingredients: IBUPROFEN 200mg
Labeler: Granules India Limited
NDC Code: 62207-365

Ibuprofen Tablets, USP 200 mg

Drug Facts

ACTIVE INGREDIENT (in each tablet/caplet)

Ibuprofen 200 mg (NSAID) *

* nonsteroidal anti-inflammatory drug

PURPOSE

Pain reliever/ fever reducer

USES
  • 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 severe stomach bleeding.
The chance 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 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 or for longer than directed

STOP USE AND ASK A 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 caplet every 4 to 6 hours while symptoms persist
    • if pain or fever does not respond to 1 caplet, 2 caplets may be used
    • do not exceed 6 caplets in 24 hours, unless directed by a doctor
    Children under 12 years
    • ask a doctor

Other Information

  • Store at 20° – 25°C (68 – 77°F). [See USP Controlled Room Temperature]
  • Avoid excessive heat above 40°C (104°F)

INACTIVE INGREDIENTS

colloidal silicon dioxide, corn starch, hypromellose, iron oxide red, lactose monohydrate, povidone k30, sodium starch glycolate, stearic acid, titanium dioxide, triacetin

QUESTIONS OR COMMENTS?

Call 1-877-770-3183:
weekdays 9:00 AM to 4:30 PM EST

MADE IN INDIA

M.L.No: 37/RR/AP/2003/F/R

Manufactured By
Granules India Limited
2nd Floor 3rd Block, My Home hub, Madhapur, Hyderabad – 500 081, INDIA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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.

IBUPROFEN 
ibuprofen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62207-365
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
POVIDONE K30 
STEARIC ACID 
SILICON DIOXIDE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
HYPROMELLOSE 2208 (100 MPA.S) 
TRIACETIN 
LACTOSE MONOHYDRATE 
TITANIUM DIOXIDE 
FERRIC OXIDE RED 
DEXTROSE MONOHYDRATE 
LECITHIN, SOYBEAN 
MALTODEXTRIN 
CARBOXYMETHYLCELLULOSE SODIUM 
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize10mm
FlavorImprint CodeG;2
Contains    
Packaging
#Item CodePackage Description
1NDC:62207-365-5110 TABLET in 1 BOTTLE
2NDC:62207-365-4124 TABLET in 1 BOTTLE
3NDC:62207-365-4250 TABLET in 1 BOTTLE
4NDC:62207-365-43100 TABLET in 1 BOTTLE
5NDC:62207-365-46250 TABLET in 1 BOTTLE
6NDC:62207-365-47500 TABLET in 1 BOTTLE
7NDC:62207-365-48750 TABLET in 1 BOTTLE
8NDC:62207-365-491000 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07917401/01/2011
IBUPROFEN 
ibuprofen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62207-366
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
POVIDONE K30 
STEARIC ACID 
SILICON DIOXIDE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
HYPROMELLOSE 2208 (100 MPA.S) 
TRIACETIN 
LACTOSE MONOHYDRATE 
TITANIUM DIOXIDE 
FERRIC OXIDE RED 
DEXTROSE MONOHYDRATE 
LECITHIN, SOYBEAN 
MALTODEXTRIN 
CARBOXYMETHYLCELLULOSE SODIUM 
Product Characteristics
ColorREDScoreno score
ShapeOVAL (caplet) Size14mm
FlavorImprint CodeG;2
Contains    
Packaging
#Item CodePackage Description
1NDC:62207-366-5110 TABLET in 1 BOTTLE
2NDC:62207-366-4124 TABLET in 1 BOTTLE
3NDC:62207-366-4250 TABLET in 1 BOTTLE
4NDC:62207-366-43100 TABLET in 1 BOTTLE
5NDC:62207-366-46250 TABLET in 1 BOTTLE
6NDC:62207-366-47500 TABLET in 1 BOTTLE
7NDC:62207-366-48750 TABLET in 1 BOTTLE
8NDC:62207-366-491000 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07917401/01/2011
Labeler - Granules India Limited (915000087)
Registrant - Granules India Limited (915000087)
Establishment
NameAddressID/FEIOperations
Granules India Limited918609236MANUFACTURE(62207-365, 62207-366)

 
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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