Tums Ultra
Calcium Carbonate
Glaxosmithkline Consumer Healthcare Holdings (us) Llc
Human Otc Drug
NDC 0135-0612Tums Ultra also known as Calcium Carbonate is a human otc drug labeled by 'Glaxosmithkline Consumer Healthcare Holdings (us) Llc'. National Drug Code (NDC) number for Tums Ultra is 0135-0612. This drug is available in dosage form of Tablet, Chewable. The names of the active, medicinal ingredients in Tums Ultra drug includes Calcium Carbonate - 1000 mg/1 . The currest status of Tums Ultra drug is Active.
Drug Information:
| Drug NDC: | 0135-0612 |
| 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: | Tums Ultra |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Tums |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | ULTRA |
| 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: | Calcium 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: | Tablet, Chewable |
| 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: | CALCIUM CARBONATE - 1000 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, 2016 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 23 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: | 308892
1044524
|
| 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: | H0G9379FGK
|
| 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 |
|---|
| 0135-0612-01 | 72 TABLET, CHEWABLE in 1 BOTTLE (0135-0612-01) | 01 Sep, 2016 | N/A | No |
| 0135-0612-02 | 160 TABLET, CHEWABLE in 1 BOTTLE (0135-0612-02) | 01 Sep, 2016 | 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:
Tums ultra calcium carbonate calcium carbonate carbonate ion calcium cation powdered cellulose dextrose, unspecified form fd&c red no. 40 aluminum oxide fd&c yellow no. 5 fd&c yellow no. 6 maltodextrin mineral oil polyethylene glycol, unspecified talc red, yellow, orange, off white tums tropical fruit: tropical punch, banana, tropical orange, pineapple tums ultra calcium carbonate calcium carbonate carbonate ion calcium cation powdered cellulose dextrose, unspecified form maltodextrin mineral oil polyethylene glycol, unspecified talc tums
Indications and Usage:
Uses relieves ⢠heartburn ⢠acid indigestion ⢠sour stomach ⢠upset stomach associated with these symptoms
Warnings:
Warnings ask a doctor or pharmacist before use if you are presently taking a prescription drug. antacids may interact with certain prescription drugs. when using this product ⢠do not take more than 7 tablets in 24 hours ⢠if pregnant do not take more than 5 tablets in 24 hours ⢠do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor keep out of reach of children.
When Using:
When using this product ⢠do not take more than 7 tablets in 24 hours ⢠if pregnant do not take more than 5 tablets in 24 hours ⢠do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor
Dosage and Administration:
Directions ⢠adults and children 12 years of age and over: chew 2-3 tablets as symptoms occur, or as directed by a doctor ⢠do not take for symptoms that persist for more than 2 weeks unless advised by a doctor
Package Label Principal Display Panel:
Principal display panel ndc 0135-0610-01 tums ® calcium carbonate antacid goes to work in seconds! tropical fruit ultra strength 1000 72 chewable tablets ©2014 gsk pareve safety sealed- do not use if printed inner seal beneath cap is missing or broken. trademarks are owned by or licensed to the gsk group of companies. dist. by: gsk consumer healthcare warren, nj 07059 ©2014 gsk or its licensor 105439xa (front label) 105440xa (back label) tums ultra tropical fruit 72 count front label
Principal display panel ndc 0135-0612-01 tums ® calcium carbonate antacid goes to work in seconds! mint ultra strength 1000 72 chewable tablets pareve safety sealed- do not use if printed inner seal beneath cap is missing or broken. trademarks are owned by or licensed to the gsk group of companies. dist. by: gsk consumer healthcare warren, nj 07059 ©2014 gsk or its licensor 105430xa (front label) 105431xa (back label) tums ultra mint 72 count front label
Further Questions:
Questions? 1-800-897-7535