NDC 68703-373 Nativeremedies Backache Ease

Arnica, Bryonia, Cimicifuga, Hypericum, Ignatia, Kali Carb, Nux Vom, Rhus Tox, Ruta

NDC Product Code 68703-373

NDC CODE: 68703-373

Proprietary Name: Nativeremedies Backache Ease 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: Arnica, Bryonia, Cimicifuga, Hypericum, Ignatia, Kali Carb, Nux Vom, Rhus Tox, Ruta 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):
3 MM
Imprint(s):
NONE

NDC Code Structure

  • 68703 - Silver Star Brands

NDC 68703-373-80

Package Description: 180 TABLET in 1 BOTTLE, GLASS

NDC Product Information

Nativeremedies Backache Ease with NDC 68703-373 is a a human over the counter drug product labeled by Silver Star Brands. The generic name of Nativeremedies Backache Ease is arnica, bryonia, cimicifuga, hypericum, ignatia, kali carb, nux vom, rhus tox, ruta. The product's dosage form is tablet and is administered via oral form.

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

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.

Nativeremedies Backache Ease 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)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)

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: Silver Star Brands
Labeler Code: 68703
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: 09-07-2021 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.

Nativeremedies Backache Ease 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

Hpus Active Ingredients

HPUS Active Ingredients: Equal volumes of each ingredient in a 12C potency: Arnica, Bryonia, Cimicifuga, Hypericum, Ignatia, Kali carb, nux vom, rhus tox, ruta.

Uses*:

Uses*: Homeopathic relief of symptoms of backache pain.*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Warnings

Warnings: If symptoms persist or worsen, consult a healthcare professional. If pregnant or breastfeeding, ask a healthcare professional before use. keep this and all medication out of reach of children. In case of overdose, get medical help or contacta Poison Control Center right away.

Directions:

Directions: chew or dissolve tablets in the mouth. For Adults and Children 12+: Take 2 tablets every 15-20 minutes up to 4 doses, then every 4 hours until symptoms subside.

Other Safety Information

Contains no artificial flavors or colorants. No gluten added. Lactose Free.Tamper resistsant for your protection. use only if saftey seal is intact.

Inactive Ingredients:

Inactive Ingredients: Magnesium Stearate, Maltodextrin, Sucrose.

Otc - Keep Out Of Reach Of Children

Keep this and all medication out of reach of children.

Otc - Pregnancy Or Breast Feeding

If pregnant or breastfeeding, ask a health professional before use.

Otc - Purpose

Temporarily relieves symptoms of backache pain.**claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

* Please review the disclaimer below.