NDC 51316-110 Cvs Pharmacy Extra Strength

Simethicone

NDC Product Code 51316-110

NDC 51316-110-18

Package Description: 2 BLISTER PACK in 1 CARTON > 9 TABLET, CHEWABLE in 1 BLISTER PACK

NDC Product Information

Cvs Pharmacy Extra Strength with NDC 51316-110 is a a human over the counter drug product labeled by Cvs. The generic name of Cvs Pharmacy Extra Strength is simethicone. The product's dosage form is tablet, chewable and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 314221.

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.

Cvs Pharmacy Extra Strength 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.


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.

  • D&C RED NO. 30 (UNII: 2S42T2808B)
  • DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)

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: Cvs
Labeler Code: 51316
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: 08-05-2021 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: 12-31-2022 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 - NO 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".

* Please review the disclaimer below.

Cvs Pharmacy Extra Strength Product Label Images

Cvs Pharmacy Extra Strength 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 Ingredient (In Each Tablet)

Simethicone 125 mg

Purpose

Anti-gas

Uses

  • For the relief of ▪pressure, bloating and fullness commonly referred to as gas

Directions

  • ▪adults: chew 1 to 2 tablets completely as needed after meals and at bedtime. Do not swallow tablets as whole.▪do not exceed 4 tablets in 24 hours except under the advice and supervision of a physician.

Other Information

  • ▪each tablets contains: calcium 45 mg▪store at room temperature▪protect from excessive heat and moistureDO NOT USE IF ANY INDVIDUAL BLISTER IS BROKEN OR OPEN

Inactive Ingredients

D&C Red No. 30, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, silicon dioxide, sucralose, tribasic calcium phosphate.

* Please review the disclaimer below.