IBUPROFEN IMMEDIATE RELEASE- ibuprofen tablet, coated

IBUPROFEN by

Drug Labeling and Warnings

IBUPROFEN by is a Otc medication manufactured, distributed, or labeled by Strides Pharma Inc, Strides Shasun Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT(S)

(in each white tablet or caplet**)

Ibuprofen USP 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

**capsule-shaped tablets                                    

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 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 USP 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 tablet or caplet every 4 to 6 hours while symptoms persist
  • if pain or fever does not respond to 1 tablet or caplet, 2 tablets or caplets may be used
  • do not exceed 6 tablets or caplets 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 imprinted text "SEALED for YOUR PROTECTION" on the safety seal under cap is broken or missing
• see end panel for lot number and expiration date
• Very low sodium
• Each tablet contains 0.714 mg of Magnesium

INACTIVE INGREDIENT (S)

colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, talc, titanium dioxide and triacetin

QUESTIONS OR COMMENTS?

Call 1-855-742-7868

Manufactured by:

Strides Shasun Limited,

Puducherry - 605 014, India

PON/DRUGS/16134193

Distributed by:

Strides Pharma Inc

East Brunswick, NJ 08816

July 2017

PRINCIPAL DISPLAY PANEL

Package Label (Round Shaped Tablets) - Principal Display Panel - 24 - Count Bottle, 200 mg Tablets

NDC: 59556-811-41

Ibuprofen Tablets USP

200 mg

Pain Reliever/Fever Reducer (NSAID)*

24 Coated Tablets

*nonsteroidal anti-inflammatory drug

Package Label (Capsule Shaped Tablets) - Principal Display Panel - 24 - Count Bottle, 200 mg Tablets

NDC: 59556-812-41

Ibuprofen Tablets USP

200 mg

Pain Reliever/Fever Reducer (NSAID)*

24 Coated Caplets**

**capsule-shaped tablets

*nonsteroidal anti-inflammatory drug

INGREDIENTS AND APPEARANCE

IBUPROFEN  IMMEDIATE RELEASE
ibuprofen tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59556-812
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)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)
TALC (UNII: 7SEV7J4R1U)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	WHITE	Score	no score
Shape	CAPSULE (CAPLET SHAPED)	Size	14mm
Flavor		Imprint Code	IBU200
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59556-812-41	1 in 1 CARTON	06/29/2018
1		24 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 59556-812-25	1 in 1 CARTON	06/29/2018
2		50 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 59556-812-06	1 in 1 CARTON	06/29/2018
3		100 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 59556-812-44	1 in 1 CARTON	06/29/2018
4		165 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 59556-812-08	1 in 1 CARTON	06/29/2018
5		1000 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA206989	06/29/2018

IBUPROFEN  IMMEDIATE RELEASE
ibuprofen tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59556-811
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)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)
TALC (UNII: 7SEV7J4R1U)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND (ROUND SHAPED)	Size	10mm
Flavor		Imprint Code	IBU200
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59556-811-41	1 in 1 CARTON	06/29/2018
1		24 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 59556-811-25	1 in 1 CARTON	06/29/2018
2		50 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 59556-811-06	1 in 1 CARTON	06/29/2018
3		100 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 59556-811-44	1 in 1 CARTON	06/29/2018
4		165 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 59556-811-08	1 in 1 CARTON	06/29/2018
5		1000 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA206989	06/29/2018

Labeler - Strides Pharma Inc (078868278)

Registrant - Strides Pharma Global Pte. Ltd. (659220961)

Establishment
Name	Address	ID/FEI	Business Operations
Strides Pharma Science Limited		871402375	ANALYSIS(59556-811, 59556-812) , MANUFACTURE(59556-811, 59556-812) , PACK(59556-811, 59556-812)