NDC 10578-105 Homeopathic Gas/bloating

Milk Thistle, Greater Celandine, Goldenrod, Dandelion, Cinchona, Goldenseal, Poison Nut

NDC Product Code 10578-105

NDC Code: 10578-105

Proprietary Name: Homeopathic Gas/bloating 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: Milk Thistle, Greater Celandine, Goldenrod, Dandelion, Cinchona, Goldenseal, Poison Nut 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):
11 MM
Imprint(s):
H;372
Score: 1

NDC Code Structure

  • 10578 - Indiana Botanic Gardens
    • 10578-105 - Homeopathic Gas/bloating

NDC 10578-105-09

Package Description: 90 TABLET in 1 BOTTLE

NDC 10578-105-90

Package Description: 90 TABLET in 1 BOTTLE

NDC Product Information

Homeopathic Gas/bloating with NDC 10578-105 is a a human over the counter drug product labeled by Indiana Botanic Gardens. The generic name of Homeopathic Gas/bloating is milk thistle, greater celandine, goldenrod, dandelion, cinchona, goldenseal, poison nut. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Indiana Botanic Gardens

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.

Homeopathic Gas/bloating 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.

  • MILK THISTLE 3 [hp_X]/1
  • CHELIDONIUM MAJUS 3 [hp_X]/1
  • SOLIDAGO VIRGAUREA FLOWERING TOP 3 [hp_X]/1
  • TARAXACUM OFFICINALE 3 [hp_X]/1
  • CINCHONA OFFICINALIS BARK 3 [hp_C]/1
  • GOLDENSEAL 3 [hp_C]/1
  • STRYCHNOS NUX-VOMICA SEED 3 [hp_C]/1

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.

  • DEXTROSE (UNII: IY9XDZ35W2)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

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: Indiana Botanic Gardens
Labeler Code: 10578
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: 08-17-2015 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: 12-31-2019 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’.

* Please review the disclaimer below.

Homeopathic Gas/bloating Product Label Images

Homeopathic Gas/bloating 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

Ingredients:

Milk thistle ........................3X HPUSGreater celandine .............3X HPUSGoldenrod .........................3X HPUSDandelion ..........................3X HPUSCinchona ...........................3C HPUSGoldenseal ........................3C HPUSPoison nut .........................3C HPUS

Inactive Ingredients:

Dextrose, Magnesium Stearate, Silica.

Suggested Use:

Adults and children over 12 years, take 1 to 2 tablets, dissolve under tongue or chew 3 times a day or as directed by a health professional. Take 15 minutes before or after meals.

Warning:

If you are taking any medications or are pregnant or breast feeding do not use prior to consulting a physician.

Any Questions?

1-800-644-8327website: www.botanicchoice.com

* Please review the disclaimer below.

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