IBUPROFEN- ibuprofen tablet 
Granules India Limited

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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:

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:

Heart attack and stroke warning: NSAIDs, except aspirin increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed

DO NOT USE

ASK A DOCTOR BEFORE USE IF

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

STOP USE AND ASK DOCTOR IF

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

OTHER INFORMATION

INACTIVE INGREDIENTS

colloidal silicon dioxide, FD&C Yellow #6, maize starch, polyethylene glycol, polyvinyl alcohol

povidone k30, pregelatinized starch, sodium starch glycolate, stearic acid, talc, titanium dioxide

QUESTIONS OR COMMENTS?

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

PRINCIPAL DISPLAY PANEL

ibu-orange-tab-50-jpgibu-orange-tab-1000-jpgibu-orange-cap-bulk-jpgibu-orange-cap-1000-jpgibu-orange-cap-50-jpg

ibu-orange-tab-bulk-jpg

IBUPROFEN 
ibuprofen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62207-357
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
TALC (UNII: 7SEV7J4R1U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
STARCH, CORN (UNII: O8232NY3SJ)  
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
POVIDONE K30 (UNII: U725QWY32X)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize10mm
FlavorImprint Code G;3
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62207-357-4124 in 1 BOTTLE; Type 0: Not a Combination Product11/17/2016
2NDC:62207-357-4250 in 1 BOTTLE; Type 0: Not a Combination Product11/17/2016
3NDC:62207-357-43100 in 1 BOTTLE; Type 0: Not a Combination Product11/17/2016
4NDC:62207-357-46250 in 1 BOTTLE; Type 0: Not a Combination Product11/17/2016
5NDC:62207-357-47500 in 1 BOTTLE; Type 0: Not a Combination Product11/17/2016
6NDC:62207-357-48750 in 1 BOTTLE; Type 0: Not a Combination Product11/17/2016
7NDC:62207-357-491000 in 1 BOTTLE; Type 0: Not a Combination Product11/17/2016
8NDC:62207-357-91160000 in 1 DRUM10/08/2018
81 in 1 BAG; Type 0: Not a Combination Product
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 AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
TALC (UNII: 7SEV7J4R1U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
STARCH, CORN (UNII: O8232NY3SJ)  
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
POVIDONE K30 (UNII: U725QWY32X)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColororangeScoreno score
ShapeOVALSize14mm
FlavorImprint Code G;3
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62207-358-4124 in 1 BOTTLE; Type 0: Not a Combination Product11/17/2016
2NDC:62207-358-4250 in 1 BOTTLE; Type 0: Not a Combination Product11/17/2016
3NDC:62207-358-43100 in 1 BOTTLE; Type 0: Not a Combination Product11/17/2016
4NDC:62207-358-46250 in 1 BOTTLE; Type 0: Not a Combination Product11/17/2016
5NDC:62207-358-47500 in 1 BOTTLE; Type 0: Not a Combination Product11/17/2016
6NDC:62207-358-48750 in 1 BOTTLE; Type 0: Not a Combination Product11/17/2016
7NDC:62207-358-491000 in 1 BOTTLE; Type 0: Not a Combination Product11/17/2016
8NDC:62207-358-91160000 in 1 DRUM11/17/2016
81 in 1 BAG; Type 0: Not a Combination Product
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/FEIBusiness Operations
Granules India Ltd918609236manufacture(62207-357, 62207-358) , label(62207-357, 62207-358)

Revised: 2/2021
Document Id: ba67be92-0460-58ae-e053-2995a90af488
Set id: b36c24b3-7bba-4698-a71c-ca617ea1060e
Version: 10
Effective Time: 20210202
 
Granules India Limited