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Ibuprofen Immediate Release by Strides Pharma Inc.

Medically reviewed on May 26, 2017

Dosage form: tablet, coated
Ingredients: IBUPROFEN 200mg
Labeler: Strides Pharma Inc.
NDC Code: 59556-856


Drugs Facts

ACTIVE INGREDIENT(S)

(ineach orange 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 USP 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 non prescription 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 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 ad 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 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
  • 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
  • you have symptoms of heart problems or stroke:
    • chest pain
    • trouble in 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 care professional before use. it is especially important not to use ibuprofen USP
 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 centre (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 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
  • Sodium free 
  • Each tablet contains 0.714 mg of Magnesium
  • see end panel for lot number and expiration date.


INACTIVE INGREDIENTS (S)

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

QUESTIONS OR COMMENTS?
Call 1-855-742-7868 (toll-free): weekdays 8.00 AM to 8.00 PM EST

Manufactured by:
Strides Shasun Limited,
Puducherry - 605 014, India.
PON/DRUGS/16134193

Distributed by:
Strides Pharma Inc.
East Brunswick, NJ 08816


May 2017



PRINCIPAL DISPLAY PANEL

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

See New Warnings

NDC 59556-856-41

Ibuprofen Tablets, USP

200 mg

Pain Reliever/Fever Reducer (NSAID)*

24 Coated Caplets**

**capsule-shaped tablets

*nonsteroidal anti-inflammatory drug


 






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


See New Warnings

NDC 59556-855-41

Ibuprofen Tablets, USP

200 mg

Pain Reliever/Fever Reducer (NSAID)*

24 Coated Tablets

*nonsteroidal anti-inflammatory drug













IBUPROFEN  IMMEDIATE RELEASE
ibuprofen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59556-856
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
STARCH, CORN 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
HYPROMELLOSES 
TITANIUM DIOXIDE 
TRIACETIN 
FD&C YELLOW NO. 6 
TALC 
Product Characteristics
ColorORANGEScoreno score
ShapeCAPSULE (CAPLET SHAPED) Size14mm
FlavorImprint CodeIBU200
Contains    
Packaging
#Item CodePackage Description
1NDC:59556-856-411 BOTTLE in 1 CARTON
124 TABLET, COATED in 1 BOTTLE
2NDC:59556-856-251 BOTTLE in 1 CARTON
250 TABLET, COATED in 1 BOTTLE
3NDC:59556-856-061 BOTTLE in 1 CARTON
3100 TABLET, COATED in 1 BOTTLE
4NDC:59556-856-441 BOTTLE in 1 CARTON
4165 TABLET, COATED in 1 BOTTLE
5NDC:59556-856-071 BOTTLE in 1 CARTON
5500 TABLET, COATED in 1 BOTTLE
6NDC:59556-856-081 BOTTLE in 1 CARTON
61000 TABLET, COATED in 1 BOTTLE
7NDC:59556-856-461000 TABLET, COATED in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09135504/04/2011
IBUPROFEN  IMMEDIATE RELEASE
ibuprofen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59556-855
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
STARCH, CORN 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
HYPROMELLOSES 
TITANIUM DIOXIDE 
TRIACETIN 
FD&C YELLOW NO. 6 
TALC 
Product Characteristics
ColorWHITEScoreno score
ShapeROUND (ROUND SHAPED) Size10mm
FlavorImprint CodeIBU200
Contains    
Packaging
#Item CodePackage Description
1NDC:59556-855-411 BOTTLE in 1 CARTON
124 TABLET, COATED in 1 BOTTLE
2NDC:59556-855-251 BOTTLE in 1 CARTON
250 TABLET, COATED in 1 BOTTLE
3NDC:59556-855-061 BOTTLE in 1 CARTON
3100 TABLET, COATED in 1 BOTTLE
4NDC:59556-855-441 BOTTLE in 1 CARTON
4165 TABLET, COATED in 1 BOTTLE
5NDC:59556-855-071 BOTTLE in 1 CARTON
5500 TABLET, COATED in 1 BOTTLE
6NDC:59556-855-081 BOTTLE in 1 CARTON
61000 TABLET, COATED in 1 BOTTLE
7NDC:59556-855-461000 TABLET, COATED in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09135504/04/2011
Labeler - Strides Pharma Inc. (078868278)
Establishment
NameAddressID/FEIOperations
Strides Shasun Limited871402375ANALYSIS(59556-855, 59556-856), MANUFACTURE(59556-855, 59556-856)

 
Strides Pharma Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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