NDC 0067-6274 Gas-x Ultra Strength Antigas Softgels
Simethicone Capsule, Liquid Filled Oral

Product Information

What is NDC 0067-6274?

The NDC code 0067-6274 is assigned by the FDA to the product Gas-x Ultra Strength Antigas Softgels which is a human over the counter drug product labeled by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The generic name of Gas-x Ultra Strength Antigas Softgels is simethicone. The product's dosage form is capsule, liquid filled and is administered via oral form. The product is distributed in 2 packages with assigned NDC codes 0067-6274-18 2 blister pack in 1 carton / 9 capsule, liquid filled in 1 blister pack, 0067-6274-50 5 blister pack in 1 carton / 10 capsule, liquid filled in 1 blister pack. 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 Code0067-6274
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.
Gas-x Ultra Strength Antigas Softgels
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Simethicone
Product Type 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.
Human Otc Drug
Dosage FormCapsule, Liquid Filled - A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle.
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.
Glaxosmithkline Consumer Healthcare Holdings (us) Llc
Labeler Code0067
FDA Application Number 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.
part332
Marketing Category 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.
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
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.
09-01-2007
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.
12-31-2023
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".
N
NDC Code Structure

What are the uses for Gas-x Ultra Strength Antigas Softgels?


Product Characteristics

Color(s)ORANGE (C48331 - OPAQUE SOFTGEL WITH WHITE PRINT LOGO)
ShapeROUND (C48348)
Size(s)11 MM
Imprint(s)G;X;U
Score1

Product Packages

NDC Code 0067-6274-18

Package Description: 2 BLISTER PACK in 1 CARTON / 9 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

Price per Unit: $0.26247 per EA

NDC Code 0067-6274-50

Package Description: 5 BLISTER PACK in 1 CARTON / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

Price per Unit: $0.26247 per EA

Product Details

What are Gas-x Ultra Strength Antigas Softgels 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.

Gas-x Ultra Strength Antigas Softgels 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:

Gas-x Ultra Strength Antigas Softgels 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.

Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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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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Gas-x Ultra Strength Antigas Softgels 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 (In Each Softgel)



Simethicone 180 mg


Purpose



Antigas


Use



for the relief of

  • •pressure and bloating commonly referred to as gas

Directions



  • •adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime
  • •do not exceed 2 softgels in 24 hours except under the advice and supervision of a physician

Other Information



  • •store at a controlled room temperature 20-25°C (68-77°F )
  • •protect from heat and moisture

Inactive Ingredients



FD&C yellow 6, gelatin, glycerin, hypromellose, light mineral oil, mannitol, peppermint oil, purified water, sorbitol, soy lecithin, titanium dioxide


Questions Or Comments?



Call 1-800-452-0051


Principal Display Panel



NDC 0067-6274-50

Gas-X®

SIMETHICONE 180 mg/ ANTIGAS

#1 DOCTOR RECOMMENDED BRAND

RELIEVES GAS FAST

PRESSURE • BLOATING • DISCOMFORT

ULTRA STRENGTH

50 SOFTGELS

Gas-X® Ultra Strength Softgels are concentrated to contain liquid gas-fighting medicine in a small softgel so they are easy to swallow, and there is no chalky taste.

TAMPER EVIDENT FEATURE:

Gas-X® Ultra Strength Softgels are sealed in blister packets. Use only if the individual seal is unbroken.

Gas-X®Ultra Strength Softgels offer fast, effective relief of pressure and bloating that antacids can’t provide. They are specially formulated with simethicone, the antigas medicine doctors recommend most for pressure, bloating or discomfort referred to as gas.

www.Gas-X.com

Distributed by

GSK Consumer Healthcare

  •  Warren, NJ 07059
  • Trademarks are owned by or licensed to the GSK group of companies.

    ©2016

    GSK group of companies or its licensor. All Rights reserved.

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* Please review the disclaimer below.