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Ibuprofen by Polygen Pharmaceuticals LLC

Dosage form: tablet, coated
Ingredients: IBUPROFEN 200mg
Labeler: Polygen Pharmaceuticals LLC
NDC Code: 52605-114

Ibuprofen Tablets,  200 mg

Active ingredient(s)

Ibuprofen 200 mg (NSAID)*

 * nonsteroidal anti-inflammatory drug


Purpose

Pain reliever/Fever reducer


Use(s)

temporarily relieves minor aches and pain due to:

  • backache
  • headache
  • menstrual cramps
  • minor pain of arthritis
  • muscular aches
  • the common cold
  • toothache
  • temporarily reduces fever

Warnings

Allergy alert: Ibuprofen may cause a severe allergy reaction, especially in people allergic to aspirin.

Symptoms may include: 

  • asthma (wheezing)
  • blisters
  • facial swelling
  • hives
  • rash
  • shock
  • skin reddening

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


Stomach bleeding warning:
This product contains an NSAID, which may cause 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
  • the 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
  • you have a history of stomach problems such as heartburn
  • the stomach bleeding warning applies to you
  • you have high blood pressure, heart disease , kidney disease, liver cirrhosis  
  • you are taking  a diuretic
  • you have asthma

Ask a doctor or pharmacist before use if
  • under a doctor’s care for any serious condition
  • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
  • 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 3 days
  • redness or swelling is present in the painful area
  • any new symptoms occur

Side effects occur. You may report side effects to PolyGen at 1-888-291-7337 and/ or FDA at 1-800-FDA-1088

Pregnancy/Breastfeeding

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 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
  •  do not use if seal under cap is broken or missing
  • see end panel for lot number and expiration date


Inactive ingredient

colloidal silicon dioxide, croscarmellose sodium, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide

Storage
  • store between 20-25 °C (68-77 ° F).

Questions

1-888-291-7337


Principal Display Panel

CARTON LABEL PDP

 

NDC: 52605-114-01

 

Compare to the active ingredient in Advil®

 

IBUPROFEN TABLETS, USP 200 mg

PAIN RELIEVER/ FEVER REDUCER (NSAID)

 

100 COATED TABLETS

 

SEE NEW WARNINGS INFORMATION
 




BOTTLE LABEL PDP

NDC: 52605-114-01

 

IBUPROFEN TABLETS, USP 200 mg

PAIN RELIEVER/ FEVER REDUCER(NSAID)

 

100 COATED TABLETS

 

SEE NEW WARNINGS INFORMATION





CARTON LABEL PDP

 

NDC: 52605-117-01

 

Compare to the active ingredient in Advil®

 

IBUPROFEN TABLETS, USP 200 mg

PAIN RELIEVER/ FEVER REDUCER (NSAID)

 

100 COATED CAPLETS

 

SEE NEW WARNINGS INFORMATION









BOTTLE LABEL PDP

NDC: 52605-117-01

 

IBUPROFEN TABLETS, USP 200 mg

PAIN RELIEVER/ FEVER REDUCER(NSAID)

 

100 COATED CAPLETS

 

SEE NEW WARNINGS INFORMATION







IBUPROFEN  
ibuprofen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52605-114
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
COLLOIDAL SILICON DIOXIDE 
FERRIC OXIDE RED 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
TALC 
TITANIUM DIOXIDE 
STARCH, CORN 
POLYVINYL ALCOHOL 
Product Characteristics
ColorBROWNScoreno score
ShapeROUNDSize10mm
FlavorImprint Code114
Contains    
Packaging
#Item CodePackage Description
1NDC:52605-114-011 BOTTLE in 1 CARTON
1100 TABLET, COATED in 1 BOTTLE
2NDC:52605-114-101000 TABLET, COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09123906/05/2012
IBUPROFEN 
ibuprofen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52605-117
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
COLLOIDAL SILICON DIOXIDE 
FERRIC OXIDE RED 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
TALC 
TITANIUM DIOXIDE 
STARCH, CORN 
POLYVINYL ALCOHOL 
Product Characteristics
ColorBROWNScoreno score
ShapeCAPSULESize15mm
FlavorImprint Code117
Contains    
Packaging
#Item CodePackage Description
1NDC:52605-117-011 BOTTLE in 1 CARTON
1100 TABLET, COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09123906/05/2012
Labeler - Polygen Pharmaceuticals LLC (962415720)
Registrant - Polygen Pharmaceuticals LLC (962415720)
Establishment
NameAddressID/FEIOperations
Marksans Pharma Limited925822975MANUFACTURE(52605-117)

Revised: 06/2013
 
Polygen Pharmaceuticals LLC

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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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