NDC 0132-0507 Phazyme

Simethicone And Calcium Carbonate

NDC Product Code 0132-0507

NDC Product Information

Phazyme with NDC 0132-0507 is a a human over the counter drug product labeled by C.b. Fleet Company, Inc.. The generic name of Phazyme is simethicone and calcium carbonate. The product's dosage form is tablet, chewable and is administered via oral form.

Labeler Name: C.b. Fleet Company, Inc.

Dosage Form: Tablet, Chewable - A solid dosage form containing medicinal substances with or without suitable diluents that is intended to be chewed, producing a pleasant tasting residue in the oral cavity that is easily swallowed and does not leave a bitter or unpleasant after-taste.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Phazyme Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • CALCIUM CARBONATE 750 mg/241
  • DIMETHICONE 250 mg/241

Inactive Ingredient(s)

About the 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.

  • ACACIA (UNII: 5C5403N26O)
  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • CITRIC ACID ACETATE (UNII: DSO12WL7AU)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • CORN SYRUP (UNII: 9G5L16BK6N)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)
  • PHOSPHORIC ACID (UNII: E4GA8884NN)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SHELLAC (UNII: 46N107B71O)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SORBIC ACID (UNII: X045WJ989B)
  • SORBITOL (UNII: 506T60A25R)
  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
  • SUCROSE (UNII: C151H8M554)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: C.b. Fleet Company, Inc.
Labeler Code: 0132
FDA Application Number: part332 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 03-01-2016 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2019 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.

Exclude Flag: N 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Information for Patients

Calcium Carbonate

Calcium Carbonate is pronounced as (kal' see um) (kar' bon ate)

Why is calcium carbonate medication prescribed?
Calcium carbonate is a dietary supplement used when the amount of calcium taken in the diet is not enough. Calcium is needed by the body for healthy bones, muscles, nervo...
[Read More]
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]

* Please review the disclaimer below.

Phazyme Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients (In Each Chew)

Calcium carbonate 750mg............... AntacidSimethicone 250mg.................. Anti-gas

Uses For The Relief Of:

  • Pressure and bloating commonly referred to as gasacid indigestionheartburnsour stomachupset stomach associated with these symptoms

When Using This Product

  • Do not take more than 2 chews in a 24-hour perioddo not use the maximum dosage of this product for more than 2 weeks except under the advice and supervision of a doctor

If Pregnant Or Breast-Feeding

Ask a doctor before use.

Ask A Doctor Or Pharmacist Before Use If You Are

Now taking a prescription drug. Antacids may interact with certain prescription drugs.

Keep Out Of Reach Of Children

Keep out of reach of children.

Directions

Adults and children 12 years and older:Chew and swallow 1 to 2 chews as symptoms occur or as directed by a doctor.

Other Information

  • Each chew contains: calcium 300mgStore between 59-77F.Don't use if allergic to this product or its ingredients.

Inactive Ingredients

Acacia, beeswax, carnuba wax, citric acid, cornstarch, corn syrup, FD&C red #40 aluminum lake, flavor, modified starch, phosphoric acid, polyvinylpyrolidone, pregelatinized modified corn starch, propylene glycol, shellac, sodium benzoate, sorbic acid, sorbitol, soy lecithin, sucrose, titanium dioxide, vegetable oil, water

Questions?

1-855-727-4277 or www.phazyme.com

* Please review the disclaimer below.

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