IBUPROFEN  - ibuprofen tablet 
Granules India Limited

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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 oldertake 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 yearsask 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

45437a24-figure-0145437a24-figure-02


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 
STARCH, CORN 
HYPROMELLOSE 2208 (100 MPA.S) 
TRIACETIN 
LACTOSE MONOHYDRATE 
TITANIUM DIOXIDE 
FERRIC OXIDE RED 
DEXTROSE MONOHYDRATE 
LECITHIN, SOYBEAN 
MALTODEXTRIN 
CARBOXYMETHYLCELLULOSE SODIUM 
Product Characteristics
ColorREDScore no score
ShapeROUNDSize10mm
FlavorImprint Code G;2
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:62207-365-4250 TABLET ( TABLET) in 1 BOTTLENone
2NDC:62207-365-43100 TABLET ( TABLET) in 1 BOTTLENone
3NDC:62207-365-4124 TABLET ( TABLET) in 1 BOTTLENone
4NDC:62207-365-46250 TABLET ( TABLET) in 1 BOTTLENone
5NDC:62207-365-47500 TABLET ( TABLET) in 1 BOTTLENone
6NDC:62207-365-48750 TABLET ( TABLET) in 1 BOTTLENone
7NDC:62207-365-491000 TABLET ( TABLET) in 1 BOTTLENone

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 
STARCH, CORN 
HYPROMELLOSE 2208 (100 MPA.S) 
TRIACETIN 
LACTOSE MONOHYDRATE 
TITANIUM DIOXIDE 
FERRIC OXIDE RED 
DEXTROSE MONOHYDRATE 
LECITHIN, SOYBEAN 
MALTODEXTRIN 
CARBOXYMETHYLCELLULOSE SODIUM 
Product Characteristics
ColorREDScore no score
ShapeOVAL (caplet) Size14mm
FlavorImprint Code G;2
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:62207-366-4250 TABLET ( TABLET) in 1 BOTTLENone
2NDC:62207-366-43100 TABLET ( TABLET) in 1 BOTTLENone
3NDC:62207-366-4124 TABLET ( TABLET) in 1 BOTTLENone
4NDC:62207-366-46250 TABLET ( TABLET) in 1 BOTTLENone
5NDC:62207-366-47500 TABLET ( TABLET) in 1 BOTTLENone
6NDC:62207-366-48750 TABLET ( TABLET) in 1 BOTTLENone
7NDC:62207-366-491000 TABLET ( TABLET) in 1 BOTTLENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07917401/01/2011

Labeler - Granules India Limited (915000087)
Establishment
NameAddressID/FEIOperations
Granules India Limited918609236MANUFACTURE

Revised: 07/2011 Granules India Limited