Ibuprofen by Granules India Limited IBUPROFEN tablet

Ibuprofen by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug Facts

ACTIVE INGREDIENT (in each tablet/caplet)

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

SPL UNCLASSIFIED SECTION

Other Information

• store at 20-25°C (68-77°F)[See USP Controlled Room Temperature]
• avoid high humidity and excessive heat above 40°C (104°F)

INACTIVE INGREDIENTS

colloidal silicon dioxide, iron oxide red, maize starch, poly ethylene glycol, povidone k-30, 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

MADE IN INDIA

M.L.No: 37/RR/AP/2003/F/R

Manufactured By
Granules India Limited
2nd Floor 3rd Block, My Home hub, Madhapur, Hyderabad – 500 081, INDIA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Do not use if the foil inner seal is broken or missing

NDC# 62207-365-41

See New Warnings Information

IBUPROFEN TABLETS USP, 200 mg

Pain Reliever/Fever Reducer (NSAID)

24 Tablets**

Important: Read all product information before using.

Do not use if the foil inner seal is broken or missing

NDC# 62207-365-49

See New Warnings Information

IBUPROFEN TABLETS USP, 200 mg

Pain Reliever/Fever Reducer (NSAID)

1000 Tablets**

Important: Read all product information before using.

Do not use if the foil inner seal is broken or missing

NDC# 62207-366-41

See New Warnings Information

IBUPROFEN TABLETS USP, 200 mg

Pain Reliever/Fever Reducer (NSAID)

24 Coated Caplets**

**Capsule-Shaped Tablets

Important: Read all product information before using.

Do not use if the foil inner seal is broken or missing

NDC# 62207-366-49

See New Warnings Information

IBUPROFEN TABLETS USP, 200 mg

Pain Reliever/Fever Reducer (NSAID)

1000 Coated Caplets**

**Capsule-Shaped Tablets

Important: Read all product information before using.

Do not use if the foil inner seal is broken or missing

NDC# 62207-395-41

See New Warnings Information

IBUPROFEN TABLETS USP, 200 mg

Pain Reliever/Fever Reducer (NSAID)

24 Tablets**

Important: Read all product information before using.

Do not use if the foil inner seal is broken or missing

NDC# 62207-395-49

See New Warnings Information

IBUPROFEN TABLETS USP, 200 mg

Pain Reliever/Fever Reducer (NSAID)

1000 Tablets**

Important: Read all product information before using.

Do not use if the foil inner seal is broken or missing

NDC# 62207-396-41

See New Warnings Information

IBUPROFEN TABLETS USP, 200 mg

Pain Reliever/Fever Reducer (NSAID)

24 Coated Caplets**

**Capsule-Shaped Tablets

Important: Read all product information before using.

Do not use if the foil inner seal is broken or missing

NDC# 62207-396-49

See New Warnings Information

IBUPROFEN TABLETS USP, 200 mg

Pain Reliever/Fever Reducer (NSAID)

1000 Coated Caplets**

**Capsule-Shaped Tablets

Important: Read all product information before using.

INGREDIENTS AND APPEARANCE

IBUPROFEN 
ibuprofen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62207-365
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
STARCH, CORN (UNII: O8232NY3SJ)
POVIDONE K30 (UNII: U725QWY32X)
STEARIC ACID (UNII: 4ELV7Z65AP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TALC (UNII: 7SEV7J4R1U)
POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)

Product Characteristics
Color	red (Reddish Brown)	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	G;2
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62207-365-51	10 in 1 BOTTLE; Type 0: Not a Combination Product	08/13/2019
2	NDC: 62207-365-41	24 in 1 BOTTLE; Type 0: Not a Combination Product	08/13/2019
3	NDC: 62207-365-42	50 in 1 BOTTLE; Type 0: Not a Combination Product	08/13/2019
4	NDC: 62207-365-43	100 in 1 BOTTLE; Type 0: Not a Combination Product	08/13/2019
5	NDC: 62207-365-46	250 in 1 BOTTLE; Type 0: Not a Combination Product	08/13/2019
6	NDC: 62207-365-47	500 in 1 BOTTLE; Type 0: Not a Combination Product	08/13/2019
7	NDC: 62207-365-48	750 in 1 BOTTLE; Type 0: Not a Combination Product	08/13/2019
8	NDC: 62207-365-49	1000 in 1 BOTTLE; Type 0: Not a Combination Product	08/13/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA079174	01/01/2011

IBUPROFEN 
ibuprofen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62207-366
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
POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)
STARCH, CORN (UNII: O8232NY3SJ)
POVIDONE K30 (UNII: U725QWY32X)
STEARIC ACID (UNII: 4ELV7Z65AP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	red (Reddish Brown)	Score	no score
Shape	OVAL ((Capsule shaped tablet))	Size	14mm
Flavor		Imprint Code	G;2
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62207-366-51	10 in 1 BOTTLE; Type 0: Not a Combination Product	08/13/2019
2	NDC: 62207-366-41	24 in 1 BOTTLE; Type 0: Not a Combination Product	08/13/2019
3	NDC: 62207-366-42	50 in 1 BOTTLE; Type 0: Not a Combination Product	08/13/2019
4	NDC: 62207-366-43	100 in 1 BOTTLE; Type 0: Not a Combination Product	08/13/2019
5	NDC: 62207-366-46	250 in 1 BOTTLE; Type 0: Not a Combination Product	08/13/2019
6	NDC: 62207-366-47	500 in 1 BOTTLE; Type 0: Not a Combination Product	08/13/2019
7	NDC: 62207-366-48	750 in 1 BOTTLE; Type 0: Not a Combination Product	08/13/2019
8	NDC: 62207-366-49	1000 in 1 BOTTLE; Type 0: Not a Combination Product	08/13/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA079174	01/01/2011

IBUPROFEN 
ibuprofen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62207-396
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
STARCH, CORN (UNII: O8232NY3SJ)
POVIDONE K30 (UNII: U725QWY32X)
STEARIC ACID (UNII: 4ELV7Z65AP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	red (Reddish Brown)	Score	no score
Shape	OVAL ((Capsule shaped tablet))	Size	14mm
Flavor		Imprint Code	G;2
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62207-396-51	10 in 1 BOTTLE; Type 0: Not a Combination Product	08/13/2019
2	NDC: 62207-396-41	24 in 1 BOTTLE; Type 0: Not a Combination Product	08/13/2019
3	NDC: 62207-396-42	50 in 1 BOTTLE; Type 0: Not a Combination Product	08/13/2019
4	NDC: 62207-396-43	100 in 1 BOTTLE; Type 0: Not a Combination Product	08/13/2019
5	NDC: 62207-396-46	250 in 1 BOTTLE; Type 0: Not a Combination Product	08/13/2019
6	NDC: 62207-396-47	500 in 1 BOTTLE; Type 0: Not a Combination Product	08/13/2019
7	NDC: 62207-396-48	750 in 1 BOTTLE; Type 0: Not a Combination Product	08/13/2019
8	NDC: 62207-396-49	1000 in 1 BOTTLE; Type 0: Not a Combination Product	08/13/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA079174	08/13/2019

IBUPROFEN 
ibuprofen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62207-395
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
STARCH, CORN (UNII: O8232NY3SJ)
POVIDONE K30 (UNII: U725QWY32X)
STEARIC ACID (UNII: 4ELV7Z65AP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TALC (UNII: 7SEV7J4R1U)
POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)

Product Characteristics
Color	red (Reddish Brown)	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	G;2
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62207-395-51	10 in 1 BOTTLE; Type 0: Not a Combination Product	08/13/2019
2	NDC: 62207-395-41	24 in 1 BOTTLE; Type 0: Not a Combination Product	08/13/2019
3	NDC: 62207-395-42	50 in 1 BOTTLE; Type 0: Not a Combination Product	08/13/2019
4	NDC: 62207-395-43	100 in 1 BOTTLE; Type 0: Not a Combination Product	08/13/2019
5	NDC: 62207-395-46	250 in 1 BOTTLE; Type 0: Not a Combination Product	08/13/2019
6	NDC: 62207-395-47	500 in 1 BOTTLE; Type 0: Not a Combination Product	08/13/2019
7	NDC: 62207-395-48	750 in 1 BOTTLE; Type 0: Not a Combination Product	08/13/2019
8	NDC: 62207-395-49	1000 in 1 BOTTLE; Type 0: Not a Combination Product	08/13/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA079174	08/13/2019

Labeler - Granules India Limited (915000087)

Registrant - Granules India Limited (915000087)

Establishment
Name	Address	ID/FEI	Business Operations
Granules India Limited		918609236	manufacture(62207-365, 62207-366, 62207-395, 62207-396)