NDC 76472-1136 Calcarea Carbonic 30c

Oyster Shell Calcium Carbonate, Crude

NDC Product Code 76472-1136

NDC CODE: 76472-1136

Proprietary Name: Calcarea Carbonic 30c What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Oyster Shell Calcium Carbonate, Crude 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.

Product Characteristics

Color(s):
WHITE (C48325)
Shape: ROUND (C48348)
Size(s):
4 MM

NDC Code Structure

  • 76472 - Sevene Usa

NDC 76472-1136-1

Package Description: 80 PELLET in 1 CYLINDER

NDC Product Information

Calcarea Carbonic 30c with NDC 76472-1136 is a a human over the counter drug product labeled by Sevene Usa. The generic name of Calcarea Carbonic 30c is oyster shell calcium carbonate, crude. The product's dosage form is pellet and is administered via sublingual form.

Dosage Form: Pellet - A small sterile solid mass consisting of a highly purified drug (with or without excipients) made by the formation of granules, or by compression and molding.

Product Type: Human Otc Drug 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.

Calcarea Carbonic 30c Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


Inactive Ingredient(s)

About the Inactive Ingredient(s)
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.

  • SUCROSE (UNII: C151H8M554)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Sublingual - Administration beneath the tongue.

Product Labeler Information

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

Labeler Name: Sevene Usa
Labeler Code: 76472
Marketing Category: UNAPPROVED HOMEOPATHIC - 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.

Start Marketing Date: 11-22-2011 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 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.

Exclude Flag: N - NO 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".

* Please review the disclaimer below.

Calcarea Carbonic 30c Product Label Images

Calcarea Carbonic 30c Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient

HOMEOPATHIC DILUTION OF HPUS CALCAREA CARBONICA 30C.

Traditionally Used For:

DELAYED TEETHING AND WALKING - CRADLE CAP - ECZEMA

Dosage & Administration

Directions: (adults/children) Dissolve 5 pellets under the tongue 3
times a day until symptoms are relieved or as directed by a physician.

Use

Condition listed above or as directed by a physician.

Warnings

Stop use and ask a physician if symptoms persist for more than 3 days or worsen.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Other Information

Store at room temperature.

Otc - Do Not Use

Do not use if pellet-dispenser seal is broken.

Inactive Ingredient

SUCROSE

Questions?

[email protected]  *  www.ollois.com  *  MADE IN CANADA. NOT REVIEWED BY THE FDA AND NOT GUARANTEED TO BE EFFECTIVE. THIS HOMEOPATHIC DILUTION MAY NOT BE SUSEPTIBLE TO SCIENTIFIC MEASUREMENT.

* Please review the disclaimer below.