NDC 52605-120 Ibuprofen

Product Information

What is NDC 52605-120?

The NDC code 52605-120 is assigned by the FDA to the product Ibuprofen which is product labeled by Polygen Pharmaceuticals Llc. The product's dosage form is and is administered via form. The product is distributed in a single package with assigned NDC code 52605-120-01 1 bottle in 1 carton / 100 tablet in 1 bottle. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code52605-120
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.
07-02-2013
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.
12-31-2019
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)WHITE (C48325)
ShapeCAPSULE (C48336)
Size(s)15 MM
Imprint(s)120
Score1

Product Packages

NDC Code 52605-120-01

Package Description: 1 BOTTLE in 1 CARTON / 100 TABLET in 1 BOTTLE

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

Product Details

Ibuprofen Active Ingredients UNII Codes

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:

Ibuprofen Inactive Ingredients UNII Codes

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.

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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]

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Ibuprofen Product Label

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.

Product Label Table of Contents



Active Ingredient(S)



(each Caplet contains)

Ibuprofen 200 mg (NSAID)*

·        Non-steroidal 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 alerts: 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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if you:

    • are age 60 or older
    • have bad stomach ulcers or bleeding problems
    • take a blood thinning (anticoagulant) or steroid drug
    • take other drug containing prescription NSAID (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
  • stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain
  • ulcers
  • bleeding problems
  • high blood pressure
  • heart or kidney disease
  • taken a diuretics
  • reached age 60 or older

Ask A Doctor Or Pharmacist Before Use If



You are

  • taking any other drugs containing an NSAID (prescription or nonprescription)
  • taking a blood thinning (anticoagulant) or steroid drug
  • under a doctor’s care for any serious condition
  • taking aspirin for heart attacks 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
  • long term continuous use may increase the risk of heart attack or stroke

Stop Use And Ask Doctor If



  • You feel faint, vomit blood, or have bloody or black stools.
  •         These are signs of stomach bleeding.

    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days
    • stomach pain or upset gets worse or lasts
    • redness or swelling is present in painful area
    • any new symptoms appear

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 a 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 PoisonControlCenter right away.


Directions



  • do not take more than directed
  • the smallest effective dose should be used
  • do not take longer than 10 days, unless directed by a doctor
    (see Warnings)
  •          

    adults and children 12 years and older
    • take 1 caplet every 4 to 6 hours while symptoms persist
    • if pain or fever does not respond to 1 caplet, 2 caplets may be used
    • do not exceed 6 caplets in 24 hours, unless directed by a doctor.
    Children under 12 years
    • ask a doctor

Storage



  • Store between 20-250C (68-770F).
  • do not use if seal under bottle cap is broken or missing.

Inactive Ingredients



Microcrystalline Cellulose, Croscarmellose Sodium, Pregelatinized starch, talc, Colloidal silicon dioxide, Magnesium stearate,polyvinyl Alcohol, Polyethylene glycol,Titanium dioxide.


Principal Display Panel



Carton Label
Thrulife
NDC : 52605-120-01
IBUPROFEN TABLETS, 200 mg
PAIN RELIEVER/ FEVER REDUCER (NSAID)
100 COATED CAPLETS
CAPSULE SHAPED TABLETS






Bottle label PDP
Thrulife
NDC:52605-120-01
IBUPROFEN TABLETS USP, 200 mg
PAIN RELIEVER/ FEVER REDUCER (NSAID)
100 COATED CAPLETS
CAPSULE SHAPED TABLETS








* Please review the disclaimer below.