Gas-x Ultra Strength Antigas Softgels
Simethicone
Glaxosmithkline Consumer Healthcare Holdings (us) Llc
Human Otc Drug
NDC 0067-6274Gas-x Ultra Strength Antigas Softgels also known as Simethicone is a human otc drug labeled by 'Glaxosmithkline Consumer Healthcare Holdings (us) Llc'. National Drug Code (NDC) number for Gas-x Ultra Strength Antigas Softgels is 0067-6274. This drug is available in dosage form of Capsule, Liquid Filled. The names of the active, medicinal ingredients in Gas-x Ultra Strength Antigas Softgels drug includes Dimethicone - 180 mg/1 . The currest status of Gas-x Ultra Strength Antigas Softgels drug is Active.
Drug Information:
| Drug NDC: | 0067-6274 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Gas-x Ultra Strength Antigas Softgels |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Gas-x |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Ultra Strength AntiGas Softgels |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Simethicone |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Glaxosmithkline Consumer Healthcare Holdings (us) Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Capsule, Liquid Filled |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | DIMETHICONE - 180 mg/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 01 Sep, 2007 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 14 May, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part332 |
| 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. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 252294
860055
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| NUI: | N0000010282
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | 92RU3N3Y1O
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class PE: | Skin Barrier Activity [PE]
|
| Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`. |
| Pharmacologic Class: | Skin Barrier Activity [PE]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 0067-6274-18 | 2 BLISTER PACK in 1 CARTON (0067-6274-18) / 9 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 01 Sep, 2007 | N/A | No |
| 0067-6274-50 | 5 BLISTER PACK in 1 CARTON (0067-6274-50) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 01 Sep, 2007 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose antigas
Product Elements:
Gas-x ultra strength antigas softgels simethicone dimethicone dimethicone silicon dioxide fd&c yellow no. 6 gelatin, unspecified glycerin hypromellose, unspecified light mineral oil mannitol peppermint oil water sorbitol lecithin, soybean titanium dioxide opaque softgel with white print logo g;x;u
Indications and Usage:
Use for the relief of ⢠pressure and bloating commonly referred to as gas
Warnings:
Warnings keep out of reach of children
Dosage and Administration:
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
Package Label Principal Display Panel:
Principal display panel #1 doctor recommended brand ndc 0067-6274-50 gas-x ® simethicone 180 mg/ antigas 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 canât provide. they are specially formulated with simethicone, the antigas medicine doctors recommend most for pressure, bloating or discomfort referred to as gas. 1-800-452-0051 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. 46177347 gas-x ultra strength softgels 50 count carton
Further Questions:
Questions or comments? call 1-800-452-0051