NUPRIN IMMEDIATE RELEASE- ibuprofen tablet, coated

NUPRIN by

Drug Labeling and Warnings

NUPRIN by is a Otc medication manufactured, distributed, or labeled by Strides Arcolab Limited, Shasun Pharmaceuticals Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT(S)

(in each tablet)

Ibuprofen USP 200 mg (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
• rash
• blisters
• shock
• skin reddening
• asthma (wheezing)

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning

This product contains a nonsteroidal anti-inflammatory drug (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

• 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 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 3days
• 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 (1-800-222-1222) right away.

DIRECTIONS

do not take more than directed
the smallest effective dose should be used

• adults and children 12 years and older:
  • take 1 tablet every 4 to 6 hours while symptoms persist
  • if pain or fever does not respond to 1 tablet, 2 tablets may be used
  • do not exceed 6 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)
• tamper evident: do not use if imprinted safety seal under cap is broken or missing
• see end panel for lot number and expiration date

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?
Adverse drug event Call (877)-244-9825

MADE IN INDIA

Mfg.Lic.No. DRUGS/PY/05 13 1523

NUPRIN® is a registered trademark of SVADS Holdings SA

Manufactured for:

Strides Pharma Inc,

East Brunswick, NJ 08816
www.nuprin.com
December 2015

PRINCIPAL DISPLAY PANEL

Package Label (Round Shaped Tablets) - Principal Display Panel, 200 mg Tablets
NDC: 64380-788-31
400 Coated Tablets
N TMNuprin®
IBUPROFEN TABLETS,USP
200 mg
Pain Reliever/Fever Reducer (NSAID)*
*nonsteroidal anti-inflammatory drug.

INGREDIENTS AND APPEARANCE

NUPRIN  IMMEDIATE RELEASE
ibuprofen tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64380-788
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)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
HYPROMELLOSES (UNII: 3NXW29V3WO)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Product Characteristics
Color	BROWN	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: 64380-788-31	1 in 1 CARTON
1		400 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	ANDA079129	12/16/2015

Labeler - Strides Arcolab Limited (650738743)

Registrant - Shasun Pharmaceuticals Limited (915786829)

Establishment
Name	Address	ID/FEI	Business Operations
Shasun Pharmaceuticals Limited		915786829	MANUFACTURE(64380-788)