Tc Max
Calcium Carbonate
Romavision Investing Llc
Human Otc Drug
NDC 80733-007Tc Max also known as Calcium Carbonate is a human otc drug labeled by 'Romavision Investing Llc'. National Drug Code (NDC) number for Tc Max is 80733-007. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Tc Max drug includes . The currest status of Tc Max drug is Active.
Drug Information:
| Drug NDC: | 80733-007 |
| 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: | Tc Max |
| 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: | Calcium Carbonate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Romavision Investing Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Kit |
| 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: | |
| 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: | 18 Jul, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 10 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: | 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, 2024 |
| 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: | Romavision Investing LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| 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 |
|---|
| 80733-007-06 | 1 KIT in 1 BOX (80733-007-06) / 1 KIT in 1 KIT * 6 PACKET in 1 NOT APPLICABLE / 237 mL in 1 PACKET | 18 Jul, 2019 | 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:
Tc max calcium carbonate calcium carbonate calcium cation glycerin .alpha.-tocopherol acetate, dl- starch, tapioca maltodextrin tricalcium phosphate sunflower oil mono/diglycerides sunflower oil xanthan gum neotame sodium bicarbonate magnesium hydroxide acesulfame potassium thaumatin sucrose advantame acacia senegal whole tc max calcium carbonate tc max calcium carbonate calcium carbonate calcium cation glycerin .alpha.-tocopherol acetate, dl- starch, tapioca maltodextrin tricalcium phosphate sunflower oil mono/diglycerides sunflower oil xanthan gum neotame sodium bicarbonate magnesium hydroxide acesulfame potassium thaumatin sucrose advantame acacia senegal whole
Drug Interactions:
Drug interactions ask a doctor or pharmacist before use if you are presently taking a prescription drug. antacids may interact with certain prescriptions drugs.
Indications and Usage:
Indications for the relief of: heartburn acid indigestion sour stomach upset stomach associated with these symptoms
Warnings:
Warnings do not take more than 4 ounces in a 24 hour period do not use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a physician if pregnant or breast feeding check with your physician before using ask a doctor before use if you have kidney disease a magnesium restricted diet a calcium restricted diet keep this and all drugs out of the reach of children
Do Not Use:
Warnings do not take more than 4 ounces in a 24 hour period do not use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a physician if pregnant or breast feeding check with your physician before using ask a doctor before use if you have kidney disease a magnesium restricted diet a calcium restricted diet keep this and all drugs out of the reach of children
Dosage and Administration:
Directions for use add the entire contents of one packet to 8 ounces of cold water and mix well. take 4 ounces once per day or as directed by a physician.
Drug Interactions:
Drug interactions ask a doctor or pharmacist before use if you are presently taking a prescription drug. antacids may interact with certain prescriptions drugs.
Package Label Principal Display Panel:
Principal display panel - 68 gram packet label vanilla ice cream flavor tc max buffered suspension 68 grams corn free soy free protein free dairy free non gmo principal display panel - 68 gram packet label
Principal display panel - 68 gram packet label vanilla ice cream flavor tc max starter kit buffered suspension corn free soy free protein free dairy free non gmo principal display panel - 68 gram packet label