NDC 0132-0215 Phazyme

Product Information

Product Code0132-0215
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.
Phazyme
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
C.b. Fleet Company, Inc.
Labeler Code0132
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.
04-01-2014
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.
12-31-2020
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

Usage Information


Product Characteristics

Color(s)PURPLE (C48327)
ShapeCAPSULE (C48336)
Size(s)11 MM
Imprint(s)PZ;250
Score1

Product Packages

NDC 0132-0215-37

Package Description: 1 BLISTER PACK in 1 BOX > 36 CAPSULE, GELATIN COATED in 1 BLISTER PACK

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

Product Details

Phazyme is product labeled by C.b. Fleet Company, Inc.. The product's dosage form is and is administered via form.


What are Phazyme Active Ingredients?

The following is the list of active ingredients in this product. 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.

  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • DIMETHICONE (UNII: 92RU3N3Y1O) (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.

  • D&C RED NO. 33 (UNII: 9DBA0SBB0L)
  • WATER (UNII: 059QF0KO0R)
  • GELATIN (UNII: 2G86QN327L)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)


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Patient Education

Simethicone

Simethicone is pronounced as (sye meth' i kone)

Why is simethicone medication prescribed?
Simethicone is used to treat the symptoms of gas such as uncomfortable or painful pressure, fullness, and bloating.This medication is sometimes prescribed for other uses;...
[Read More]

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Phazyme 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



(in each softgel)

Simethicone 250mg


Purpose



Anti-gas


Use



relieves bloating, pressure or fullness commonly referred to as gas


Stop Use And Ask A Doctor If



Stop use and ask a doctor if condition persists


Directions



  • swallow one or two softgels after a meal
  • do not exceed two softgels per 24 hours except under the advice and supervision of a physician

Other Information



  • store at room temperature 59° - 86°F (15° - 30°C)

Inactive Ingredients



Red No. 33, FD&C Blue No. 1, Purified Water, Gelatin, Glycerin, Titanium Dioxide


Questions?



Call toll-free 1-855-727-4277


Package Label.Principal Display Panel




* Please review the disclaimer below.