Ibuprofen by Granules India Limited / Granules India Ltd IBUPROFEN tablet

Ibuprofen by

Drug Labeling and Warnings

Ibuprofen by is a Otc medication manufactured, distributed, or labeled by Granules India Limited, Granules India Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

• 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 stomach

bleeding. The chances 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, or kidney disease, asthma or had a stroke
• 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

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 than10 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 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

• store between 20° to 25°C (68° to 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, 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

INGREDIENTS AND APPEARANCE

IBUPROFEN 
ibuprofen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62207-357
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	200 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	orange	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	G;3
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62207-357-41	24 in 1 BOTTLE; Type 0: Not a Combination Product	11/17/2016
2	NDC: 62207-357-42	50 in 1 BOTTLE; Type 0: Not a Combination Product	11/17/2016
3	NDC: 62207-357-43	100 in 1 BOTTLE; Type 0: Not a Combination Product	11/17/2016
4	NDC: 62207-357-46	250 in 1 BOTTLE; Type 0: Not a Combination Product	11/17/2016
5	NDC: 62207-357-47	500 in 1 BOTTLE; Type 0: Not a Combination Product	11/17/2016
6	NDC: 62207-357-48	750 in 1 BOTTLE; Type 0: Not a Combination Product	11/17/2016
7	NDC: 62207-357-49	1000 in 1 BOTTLE; Type 0: Not a Combination Product	11/17/2016
8	NDC: 62207-357-91	160000 in 1 DRUM	10/08/2018
8		1 in 1 BAG; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA202312	11/17/2016

IBUPROFEN 
ibuprofen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62207-358
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	200 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	orange	Score	no score
Shape	OVAL	Size	14mm
Flavor		Imprint Code	G;3
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62207-358-41	24 in 1 BOTTLE; Type 0: Not a Combination Product	11/17/2016
2	NDC: 62207-358-42	50 in 1 BOTTLE; Type 0: Not a Combination Product	11/17/2016
3	NDC: 62207-358-43	100 in 1 BOTTLE; Type 0: Not a Combination Product	11/17/2016
4	NDC: 62207-358-46	250 in 1 BOTTLE; Type 0: Not a Combination Product	11/17/2016
5	NDC: 62207-358-47	500 in 1 BOTTLE; Type 0: Not a Combination Product	11/17/2016
6	NDC: 62207-358-48	750 in 1 BOTTLE; Type 0: Not a Combination Product	11/17/2016
7	NDC: 62207-358-49	1000 in 1 BOTTLE; Type 0: Not a Combination Product	11/17/2016
8	NDC: 62207-358-91	160000 in 1 DRUM	11/17/2016
8		1 in 1 BAG; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA202312	11/17/2016

Labeler - Granules India Limited (915000087)

Registrant - Granules India Limited (915000087)

Establishment
Name	Address	ID/FEI	Business Operations
Granules India Ltd		918609236	manufacture(62207-357, 62207-358) , label(62207-357, 62207-358)