IBUPROFEN- ibuprofen tablet 
Granules India Limited

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Ibuprofen Tablets, USP 200 mg

ACTIVE INGREDIENT(S)

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

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

■ 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, kidney disease, asthma or had a  stroke

■ you are taking a diuretic

ASK A DOCTOR OR PHARMACIST BEFORE USE IF

■ 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

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

■ you have symptoms of heart problems or stroke:

•chest pain

•trouble breathing

•weakness in one part or side of body

•slurred speech

•leg swelling

■ 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 at 20 weeks or later in 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/tablet every 4 to 6 hours while symptoms persist
  • if pain or fever does not respond to 1 caplet/tablet, 2 caplets/tablets may be used
  • do not exceed 6 caplets/tablets in 24 hours, unless directed by a doctor
  children under 12 years
  • ask a doctor

Other Information

• store between 20° – 25°C (68 – 77°F).
• do not use if neck wrap or foil inner seal is broken or missing

Inactive Ingredients

colloidal silicon dioxide, FD&C Yellow #6, maize starch, Povidone k30, polyethylene glycol, polyvinyl alcohol,  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

62207-320-46-250s-bottle-label-round62207-321-46-250s-carton62207-320-46-250s-carton-round62207-320-46-250s-bottle-label-round62207-321-91-bulk-label-jpg62207-320-91-bulk-label-jpg

IBUPROFEN 
ibuprofen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62207-320
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
STARCH, CORN (UNII: O8232NY3SJ)  
POVIDONE K30 (UNII: U725QWY32X)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize10mm
FlavorImprint Code G2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62207-320-4124 in 1 BOTTLE; Type 0: Not a Combination Product11/14/2019
2NDC:62207-320-4250 in 1 BOTTLE; Type 0: Not a Combination Product11/14/2019
3NDC:62207-320-43100 in 1 BOTTLE; Type 0: Not a Combination Product11/14/2019
4NDC:62207-320-46250 in 1 BOTTLE; Type 0: Not a Combination Product11/14/2019
5NDC:62207-320-47500 in 1 BOTTLE; Type 0: Not a Combination Product11/14/2019
6NDC:62207-320-48750 in 1 BOTTLE; Type 0: Not a Combination Product11/14/2019
7NDC:62207-320-491000 in 1 BOTTLE; Type 0: Not a Combination Product11/14/2019
8NDC:62207-320-91160000 in 1 DRUM; Type 0: Not a Combination Product11/14/2019
9NDC:62207-320-8910 in 1 BOTTLE; Type 0: Not a Combination Product12/03/2020
10NDC:62207-320-901700 in 1 BOTTLE; Type 0: Not a Combination Product12/03/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20231211/14/2019
IBUPROFEN 
ibuprofen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62207-321
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
STARCH, CORN (UNII: O8232NY3SJ)  
POVIDONE K30 (UNII: U725QWY32X)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColororangeScoreno score
ShapeOVALSize14mm
FlavorImprint Code G2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62207-321-4124 in 1 BOTTLE; Type 0: Not a Combination Product11/14/2019
2NDC:62207-321-4250 in 1 BOTTLE; Type 0: Not a Combination Product11/14/2019
3NDC:62207-321-43100 in 1 BOTTLE; Type 0: Not a Combination Product11/14/2019
4NDC:62207-321-46250 in 1 BOTTLE; Type 0: Not a Combination Product11/14/2019
5NDC:62207-321-47500 in 1 BOTTLE; Type 0: Not a Combination Product11/14/2019
6NDC:62207-321-48750 in 1 BOTTLE; Type 0: Not a Combination Product11/14/2019
7NDC:62207-321-491000 in 1 BOTTLE; Type 0: Not a Combination Product11/14/2019
8NDC:62207-321-91160000 in 1 DRUM; Type 0: Not a Combination Product11/14/2019
9NDC:62207-321-8910 in 1 BOTTLE; Type 0: Not a Combination Product12/03/2020
10NDC:62207-321-901700 in 1 BOTTLE; Type 0: Not a Combination Product12/03/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20231211/14/2019
Labeler - Granules India Limited (915000087)
Establishment
NameAddressID/FEIBusiness Operations
Granules India Ltd918609236analysis(62207-320, 62207-321) , label(62207-320, 62207-321) , manufacture(62207-320, 62207-321) , pack(62207-320, 62207-321)

Revised: 1/2023
Document Id: f37bc244-5479-3bfe-e053-2a95a90acf61
Set id: 97516b9f-219a-429d-850d-1fe9fd66646b
Version: 5
Effective Time: 20230130
 
Granules India Limited