NUPRIN IMMEDIATE RELEASE- ibuprofen tablet, coated 
Strides Pharma Science Limited

----------

Nuprin
IbuprofenTablets, USP 200 mg
Drug Facts

OTC - ACTIVE INGREDIENT SECTION

(in each tablet)

Ibuprofen USP 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

OTC - PURPOSE SECTION

Pain reliever/fever reducer

INDICATIONS AND USAGE

  • 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

OTC - DO NOT USE

  • if you have ever had an allergic reaction to any other pain reliever / fever reducer
  • right before or after heart surgery

OTC - ASK DOCTOR

  • 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

OTC - ASK DOCTOR/PHARMACIST

  • 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

OTC - WHEN USING

  • 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

OTC - STOP USE

  • 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.

OTC - 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.

DOSAGE AND ADMINISTRATION

• 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

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.comDecember 2015

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

NDC 64380-788-31400 Coated Tablets

NTMNuprin®

IBUPROFEN TABLETS,USP

200 mg

Pain Reliever/Fever Reducer (NSAID)*

*nonsteroidal anti-inflammatory drug

400s-label
400s-carton
NUPRIN  IMMEDIATE RELEASE
ibuprofen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64380-788
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorBROWNScoreno score
ShapeROUND (ROUND SHAPED) Size10mm
FlavorImprint Code IBU200
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64380-788-311 in 1 CARTON12/16/201505/31/2023
1400 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07912912/16/201505/31/2023
Labeler - Strides Pharma Science Limited (650738743)
Registrant - Strides Pharma Global Pte. Ltd. (659220961)
Establishment
NameAddressID/FEIBusiness Operations
Strides Pharma Science Limited871402375ANALYSIS(64380-788) , MANUFACTURE(64380-788) , PACK(64380-788)

Revised: 5/2023
 
Strides Pharma Science Limited