IBUPROFEN- ibuprofen tablet 
Granules India Limited

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Ibuprofen Tablets USP 200 mg (Brown)

Drug Facts

ACTIVE INGREDIENT

(in each tablet)

Ibuprofen 200 mg (NSAID)*

PURPOSE

Pain reliever/fever reducer*nonsteroidal anti-inflammatory drug

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 id 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 a caplet every 4 to 6 hours while symptoms persist
■ if pain or fever dose not respond to 1 tablet, 2 tablets may be used
■ do not exceed 6 tablets in 24 hours , unless directed by a doctor
childer under 12 years■ ask a doctor

OTHER INFORMATION

■ store between 20-25ºC (68-77ºF)

■ 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, dextrose monohydrate, hypromellose, iron oxide red, lactose monohydrate, lecithin, maize starch, maltodextrin, pregelatinized starch, povidone k30, sodium starch glycolate, stearicacid, sodium carboxymellose, triacetin, titanium dioxide

QUESTIONS OR COMMENTS?

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

M.L. 37/RR/AR/2003/F/R
Manufactured By:
Granules India Limited
2nd Floor 3rd Black, My Home hub
Madhapur, Hyderabad – 500 081, India

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ibu-200mg-round-80kg.jpgibu-roundibu-caplet

365-68365-68-shipper366-68366-68-shipper

IBUPROFEN 
ibuprofen tablet
Product Information
Product TypeBULK INGREDIENTItem Code (Source)NDC:62207-365
Route of AdministrationNOT APPLICABLE
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
POVIDONE K30 (UNII: U725QWY32X)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
TRIACETIN (UNII: XHX3C3X673)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
Product Characteristics
ColorredScoreno score
ShapeROUNDSize10mm
FlavorImprint Code G;2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62207-365-2448000 in 1 BOX01/01/2011
2NDC:62207-365-2571000 in 1 BOX01/01/2011
3NDC:62207-365-2680000 in 1 BOX01/01/2011
4NDC:62207-365-2797000 in 1 BOX01/01/2011
5NDC:62207-365-66258000 in 1 DRUM01/01/2011
6NDC:62207-365-67190476 in 1 DRUM01/01/2011
7NDC:62207-365-80258000 in 1 DRUM01/01/2011
8NDC:62207-365-68175000 in 1 BOX01/01/2011
9NDC:62207-365-16258899 in 1 DRUM11/10/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export only01/01/2011
IBUPROFEN 
ibuprofen tablet
Product Information
Product TypeBULK INGREDIENTItem Code (Source)NDC:62207-366
Route of AdministrationNOT APPLICABLE
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
POVIDONE K30 (UNII: U725QWY32X)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
TRIACETIN (UNII: XHX3C3X673)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
Product Characteristics
ColorredScoreno score
ShapeOVAL (caplet) Size14mm
FlavorImprint Code G;2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62207-366-2448000 in 1 BOX01/01/2011
2NDC:62207-366-2571000 in 1 BOX01/01/2011
3NDC:62207-366-2680000 in 1 BOX01/01/2011
4NDC:62207-366-2797000 in 1 BOX01/01/2011
5NDC:62207-366-66258000 in 1 DRUM01/01/2011
6NDC:62207-366-67190476 in 1 DRUM01/01/2011
7NDC:62207-366-80258000 in 1 DRUM01/01/2011
8NDC:62207-366-68175000 in 1 BOX01/01/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export only01/01/2011
Labeler - Granules India Limited (915000087)
Registrant - Granules India Limited (915000087)
Establishment
NameAddressID/FEIBusiness Operations
Granules India Limited918609236manufacture(62207-365, 62207-366)

Revised: 12/2023
Document Id: 0c7560d7-60fa-371c-e063-6294a90a71c6
Set id: 282dcd2b-4845-43e3-bbae-873fdfc44ca7
Version: 9
Effective Time: 20231214
 
Granules India Limited