Gaviscon
Aluminum Hydroxide And Magnesium Carbonate
Glaxosmithkline Consumer Healthcare Holdings (us) Llc
Human Otc Drug
NDC 0135-0095Gaviscon also known as Aluminum Hydroxide And Magnesium Carbonate is a human otc drug labeled by 'Glaxosmithkline Consumer Healthcare Holdings (us) Llc'. National Drug Code (NDC) number for Gaviscon is 0135-0095. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Gaviscon drug includes Aluminum Hydroxide - 254 mg/5mL Magnesium Carbonate - 237.5 mg/5mL . The currest status of Gaviscon drug is Active.
Drug Information:
| Drug NDC: | 0135-0095 |
| 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: | Gaviscon |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| 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: | Aluminum Hydroxide And Magnesium Carbonate |
| 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: | Liquid |
| 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: | ALUMINUM HYDROXIDE - 254 mg/5mL
MAGNESIUM CARBONATE - 237.5 mg/5mL
|
| 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: | 14 Jan, 2011 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 19 Dec, 2025 |
| 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: | part331 |
| 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: | 245001
252203
404472
1251365
|
| 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. |
| UNII: | 0E53J927NA
5QB0T2IUN0
|
| 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. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 0135-0095-41 | 355 mL in 1 BOTTLE (0135-0095-41) | 14 Jan, 2011 | 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 antacid
Product Elements:
Gaviscon aluminum hydroxide and magnesium carbonate aluminum hydroxide aluminum hydroxide magnesium carbonate carbonate ion benzyl alcohol d&c yellow no. 10 edetate disodium fd&c blue no. 1 glycerin saccharin sodium sodium alginate sorbitol water xanthan gum cool mint gaviscon aluminum hydroxide and magnesium carbonate aluminum hydroxide aluminum hydroxide magnesium carbonate carbonate ion benzyl alcohol edetate disodium glycerin saccharin sodium dimethicone silicon dioxide sodium alginate sorbitol water xanthan gum cool mint gaviscon aluminum hydroxide and magnesium carbonate aluminum hydroxide aluminum hydroxide magnesium carbonate carbonate ion benzyl alcohol edetate disodium glycerin saccharin sodium dimethicone silicon dioxide sodium alginate sorbitol water xanthan gum
Indications and Usage:
Uses relieves ⢠heartburn ⢠acid indigestion ⢠sour stomach ⢠upset stomach associated with these symptoms
Warnings:
Warnings do not use if you have kidney disease ask a doctor or pharmacist before use if you are ï· have kidney disease. ï· are on a sodium-restricted diet or a magnesium-restricted diet. ï· are taking a prescription drug. antacids may interact with certain prescription drugs. when using this product (regular strength) ⢠do not take more than 8 tablespoonfuls in 24 hours ⢠do not use the maximum dosage for more than 2 weeks ⢠laxative effect may occur when using this product (extra strength) ⢠do not take more than 16 teaspoonfuls in 24 hours ⢠do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor ⢠laxative effect may occur keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away.
Do Not Use:
Warnings do not use if you have kidney disease ask a doctor or pharmacist before use if you are ï· have kidney disease. ï· are on a sodium-restricted diet or a magnesium-restricted diet. ï· are taking a prescription drug. antacids may interact with certain prescription drugs. when using this product (regular strength) ⢠do not take more than 8 tablespoonfuls in 24 hours ⢠do not use the maximum dosage for more than 2 weeks ⢠laxative effect may occur when using this product (extra strength) ⢠do not take more than 16 teaspoonfuls in 24 hours ⢠do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor ⢠laxative effect may occur keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away.
When Using:
When using this product (regular strength) ⢠do not take more than 8 tablespoonfuls in 24 hours ⢠do not use the maximum dosage for more than 2 weeks ⢠laxative effect may occur
When using this product (extra strength) ⢠do not take more than 16 teaspoonfuls in 24 hours ⢠do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor ⢠laxative effect may occur
Dosage and Administration:
Directions (regular strength) ⢠shake well ⢠take 1-2 tablespoonfuls four times a day or as directed by a doctor ⢠take after meals and at bedtime ⢠dispense product only by spoon or other measuring device
Directions (extra strength) ⢠shake well ⢠take 2-4 teaspoonfuls four times a day or as directed by a doctor ⢠take after meals and at bedtime ⢠dispense product only by spoon or other measuring device
Package Label Principal Display Panel:
Principal display panel ndc 0135-0094-41 gaviscon ® regular strength liquid antacid ⢠fast-acting heartburn relief ⢠helps keep acid down for hours cool mint flavor 12 fl oz (355 ml) ©2010 glaxosmithkline front: 100631xb back: 100632xa gaviscon regular strength 12 fl oz label
Principal display panel ndc 0135-0095-41 gaviscon ® extra strength liquid antacid ⢠fast-acting heartburn relief ⢠helps keep acid down for hours cool mint flavor 12 fl oz (355 ml) ©2010 glaxosmithkline front: 100651xb back: 100652xa gaviscon extra strength 12 fl oz label
Principal display panel ndc 0135-0574-01 gaviscon ® extra strength liquid antacid ⢠fast-acting heartburn relief ⢠helps keep acid down for hours cherry flavor 12 fl oz (355 ml) ©2014 glaxosmithkline front: 103698xa back: 103699xa gavison extra strength cherry 12 fl oz (355ml) label
Further Questions:
Questions or comments? call toll-free (english/spanish) 1-888-367-6471 weekdays distributed by: glaxosmithkline consumer healthcare, l.p. moon twp, pa 15108, made in the u.s.a important: do not use if foil inner seal imprinted "sealed for your protection" is disturbed or missing.