NDC 53645-1021 Aurum Metallicum

Aurum Metallicum

NDC Product Code 53645-1021

NDC 53645-1021-2

Package Description: 23 g in 1 BOTTLE

NDC Product Information

Aurum Metallicum with NDC 53645-1021 is a a human over the counter drug product labeled by True Botanica, Llc. The generic name of Aurum Metallicum is aurum metallicum. The product's dosage form is globule and is administered via oral form.

Labeler Name: True Botanica, Llc

Dosage Form: Globule - Also called pellets or pilules, are made of pure sucrose, lactose, or other polysaccharides. They are formed into small globular masses of various sizes, and are medicated by placing them in a vial and adding the liquid drug attenuation in the proportion not less than one percent (v/w). After shaking, the medicated globules are dried at temperatures not to exceed 40 degrees Centigrade.

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.

Aurum Metallicum 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.

  • GOLD 30 [hp_X]/23g

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.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

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

Labeler Name: True Botanica, Llc
Labeler Code: 53645
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: 06-28-2013 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: 12-31-2021 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 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. Values = ‘Y’ or ‘N’.

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Aurum Metallicum Product Label Images

Aurum Metallicum 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

Otc - Active Ingredient

Aurum Metallicum 30X, HPUSThe letters HPUS indicate that these ingredients are officially included in the Homeopathic Pharmacopoeia of the United States.

Otc - Purpose

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Use:

For temporary relief of depressed mood. Supports the circulation. May also be used for standard homeopathic indications or as directed by your physician.

Warnings:

Consult your health care provider if symptoms persist more than 5 days or worsen.

Otc - Pregnancy Or Breast Feeding

If pregnant or breastfeeding ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of the reach of children.

Otc - Do Not Use

TAMPER EVIDENT: Do not use if safety seal is broken before first use.

Directions For Use:

Place globules under tongue for 30 seconds. Adults~3-5 globules 3 times a day. Children 2-12 years ~ 1-3 globules 3 times a day. Under 2 years, consult your doctor. Use until symptoms are relieved or as directed by your health care provider.

Other Ingredients:

Sucrose

Otc - Questions

Developed and Made byTrue Botanica, LLC1005 Richards Rd., Suite DHartland, WI 53029800-315-8783www.truebotanica.com

* Please review the disclaimer below.