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 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 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/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

INGREDIENTS AND APPEARANCE

IBUPROFEN 
ibuprofen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62207-320
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
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
Color	orange	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	G2
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62207-320-41	24 in 1 BOTTLE; Type 0: Not a Combination Product	11/14/2019
2	NDC: 62207-320-42	50 in 1 BOTTLE; Type 0: Not a Combination Product	11/14/2019
3	NDC: 62207-320-43	100 in 1 BOTTLE; Type 0: Not a Combination Product	11/14/2019
4	NDC: 62207-320-46	250 in 1 BOTTLE; Type 0: Not a Combination Product	11/14/2019
5	NDC: 62207-320-47	500 in 1 BOTTLE; Type 0: Not a Combination Product	11/14/2019
6	NDC: 62207-320-48	750 in 1 BOTTLE; Type 0: Not a Combination Product	11/14/2019
7	NDC: 62207-320-49	1000 in 1 BOTTLE; Type 0: Not a Combination Product	11/14/2019
8	NDC: 62207-320-91	160000 in 1 DRUM; Type 0: Not a Combination Product	11/14/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA202312	11/14/2019

IBUPROFEN 
ibuprofen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62207-321
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
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
Color	orange	Score	no score
Shape	OVAL	Size	14mm
Flavor		Imprint Code	G2
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62207-321-41	24 in 1 BOTTLE; Type 0: Not a Combination Product	11/14/2019
2	NDC: 62207-321-42	50 in 1 BOTTLE; Type 0: Not a Combination Product	11/14/2019
3	NDC: 62207-321-43	100 in 1 BOTTLE; Type 0: Not a Combination Product	11/14/2019
4	NDC: 62207-321-46	250 in 1 BOTTLE; Type 0: Not a Combination Product	11/14/2019
5	NDC: 62207-321-47	500 in 1 BOTTLE; Type 0: Not a Combination Product	11/14/2019
6	NDC: 62207-321-48	750 in 1 BOTTLE; Type 0: Not a Combination Product	11/14/2019
7	NDC: 62207-321-49	1000 in 1 BOTTLE; Type 0: Not a Combination Product	11/14/2019
8	NDC: 62207-321-91	160000 in 1 DRUM; Type 0: Not a Combination Product	11/14/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA202312	11/14/2019

Labeler - Granules India Limited (915000087)

Establishment
Name	Address	ID/FEI	Business Operations
Granules India Ltd		918609236	analysis(62207-320, 62207-321) , label(62207-320, 62207-321) , manufacture(62207-320, 62207-321) , pack(62207-320, 62207-321)