NDC 62106-1062 Calcarea Carbonica 6x

Impure Calcium Carbonate Tablet Sublingual - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
62106-1062
Proprietary Name:
Calcarea Carbonica 6x
Non-Proprietary Name: [1]
Impure Calcium Carbonate
Substance Name: [2]
Oyster Shell Calcium Carbonate, Crude
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route(s): [4]
  • Sublingual - Administration beneath the tongue.
  • Labeler Name: [5]
    Seroyal Usa
    Labeler Code:
    62106
    Marketing Category: [8]
    UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
    Start Marketing Date: [9]
    01-20-2015
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    WHITE (C48325)
    Shape:
    ROUND (C48348)
    Size(s):
    7 MM
    Score:
    1

    Product Packages

    NDC Code 62106-1062-2

    Package Description: 1 BOTTLE, GLASS in 1 CARTON / 100 TABLET in 1 BOTTLE, GLASS

    Product Details

    What is NDC 62106-1062?

    The NDC code 62106-1062 is assigned by the FDA to the product Calcarea Carbonica 6x which is a human over the counter drug product labeled by Seroyal Usa. The generic name of Calcarea Carbonica 6x is impure calcium carbonate. The product's dosage form is tablet and is administered via sublingual form. The product is distributed in a single package with assigned NDC code 62106-1062-2 1 bottle, glass in 1 carton / 100 tablet in 1 bottle, glass. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Calcarea Carbonica 6x?

    Uses For the temporary relief of minor muscle cramps menstrual crampsDirectionsTip bottle slightly allowing for tablets to fall into the cap. Use cap to drop tablets into mouth and allow them to dissolve under the tongue. Adults and Adolescents (12 years and older): Take 1 to 4 tablets, one to four times daily, or as recommended by your healthcare practitioner. Children (under 12 years): Take under the direction of your healthcare practitioner. Uses Helps to promote general bone and joint health. Support general normal growth. DirectionsTip bottle slightly allowing for tablets to fall into the cap. Use cap to drop tablets into mouth and allow them to dissolve under the tongue. Adults and adolescents (12 years and older) Take 1 to 4 tablets, one to four times daily, or as recommended by your healthcare practitioner. Children (under 12 years) Take under the direction of your healthcare practitioner. IndicationsFor the temporary relief of symptoms associated withminor tooth painteethingDirectionsTip bottle slightly allowing for tablets to fall into the cap. Use cap to drop tablets into mouth and allow them to dissolve under the tongue. Adults and adolescents (12 years and older): Take 1 to 4 tablets, one to four times daily, or as recommended by your healthcare practitioner. Children (under 12 years): Take under the direction of your healthcare practitioner.

    What are Calcarea Carbonica 6x 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.

    Which are Calcarea Carbonica 6x UNII Codes?

    The UNII codes for the active ingredients in this product are:

    • MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q)
    • MAGNESIUM CATION (UNII: T6V3LHY838) (Active Moiety)
    • OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I)
    • OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (Active Moiety)

    Which are Calcarea Carbonica 6x 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. The UNII codes for the inactive ingredients in this product are:

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    Product Footnotes

    [1] 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.

    [2] What is the Substance Name? - 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.

    [3] 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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [8] 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.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] 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] 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".