NDC 52605-117 Ibuprofen

Product Information

Ibuprofen is product labeled by Polygen Pharmaceuticals Llc. The product's dosage form is and is administered via form.

Product Code52605-117
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Ibuprofen
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Polygen Pharmaceuticals Llc
Labeler Code52605
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
06-05-2012
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
12-31-2017
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
I
NDC Code Structure

What are the uses for Ibuprofen?


Product Characteristics

Color(s)BROWN (C48332)
ShapeROUND (C48348)
CAPSULE (C48336)
Size(s)10 MM
15 MM
Imprint(s)114
117
Score1

Product Packages

NDC 52605-117-01

Package Description: 1 BOTTLE in 1 CARTON > 100 TABLET, COATED in 1 BOTTLE

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Product Details

What are Ibuprofen Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • IBUPROFEN (UNII: WK2XYI10QM)
  • IBUPROFEN (UNII: WK2XYI10QM) (Active Moiety)

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Inactive Ingredient(s)

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • POLYVINYL ALCOHOL (UNII: 532B59J990)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • POLYVINYL ALCOHOL (UNII: 532B59J990)

* Please review the disclaimer below.

Patient Education

Ibuprofen

Ibuprofen is pronounced as (eye byoo' proe fen)

Why is ibuprofen medication prescribed?
Prescription ibuprofen is used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints)...
[Read More]

* Please review the disclaimer below.

Ibuprofen Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



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








* Please review the disclaimer below.