NDC 43406-0613 Gblv Hp

Atropa Belladonna, Berberis Vulgaris Root Bark, Milk Thistle, Chelidonium Majus, Citrullus Colocynthis Fruit Pulp, Dioscorea Villosa Tuber, Goldenseal, Lycopodium Clavatum Spore, Sodium Sulfate, Strychnos Nux-vomica Seed, Phosphorus, Anemone Pulsatilla, Veratrum Album Root

NDC Product Code 43406-0613

NDC Code: 43406-0613

Proprietary Name: Gblv Hp 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: Atropa Belladonna, Berberis Vulgaris Root Bark, Milk Thistle, Chelidonium Majus, Citrullus Colocynthis Fruit Pulp, Dioscorea Villosa Tuber, Goldenseal, Lycopodium Clavatum Spore, Sodium Sulfate, Strychnos Nux-vomica Seed, Phosphorus, Anemone Pulsatilla, Veratrum Album Root 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.

NDC Code Structure

  • 43406 - Natural Creations, Inc.
    • 43406-0613 - Gblv Hp

NDC 43406-0613-1

Package Description: 30 mL in 1 BOTTLE, DROPPER

NDC Product Information

Gblv Hp with NDC 43406-0613 is a a human over the counter drug product labeled by Natural Creations, Inc.. The generic name of Gblv Hp is atropa belladonna, berberis vulgaris root bark, milk thistle, chelidonium majus, citrullus colocynthis fruit pulp, dioscorea villosa tuber, goldenseal, lycopodium clavatum spore, sodium sulfate, strychnos nux-vomica seed, phosphorus, anemone pulsatilla, veratrum album root. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Natural Creations, Inc.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Gblv Hp 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.

  • ATROPA BELLADONNA 30 [hp_C]/mL
  • BERBERIS VULGARIS ROOT BARK 30 [hp_C]/mL
  • MILK THISTLE 30 [hp_C]/mL
  • CHELIDONIUM MAJUS 30 [hp_C]/mL
  • CITRULLUS COLOCYNTHIS FRUIT PULP 30 [hp_C]/mL
  • DIOSCOREA VILLOSA TUBER 30 [hp_C]/mL
  • GOLDENSEAL 30 [hp_C]/mL
  • LYCOPODIUM CLAVATUM SPORE 30 [hp_C]/mL
  • SODIUM SULFATE 30 [hp_C]/mL
  • STRYCHNOS NUX-VOMICA SEED 30 [hp_C]/mL
  • PHOSPHORUS 30 [hp_C]/mL
  • ANEMONE PULSATILLA 30 [hp_C]/mL
  • VERATRUM ALBUM ROOT 30 [hp_C]/mL

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.

  • WATER (UNII: 059QF0KO0R)
  • ALCOHOL (UNII: 3K9958V90M)

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: Natural Creations, Inc.
Labeler Code: 43406
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: 06-01-2016 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.

Gblv Hp Product Label Images

Gblv Hp 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

ACTIVE INGREDIENTS (HPUS*) - equal amounts of: Belladonna 30C, Berberis Vulg 30C, Carduus Mar 30C, Chelidonium Maj 30C, Colocynthis 30C, Dioscorea 30C, Hydrastis 30C, Lycopodium 30C, Nat Sulphuricum 30C, Nux Vom 30C, Phos 30C, Pulsatilla 30C, Veratrum Alb 30C.

Otc - Purpose

USES: Temporarily relieves flatulence, constipation, and belching.**

Indications & Usage

USES: Temporarily relieves flatulence, constipation, and belching.**

Dosage & Administration

DIRECTIONS: Adults & children above 12 years: 10 drops orally 3 times daily, or as directed by a health care professional.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.

Warnings

WARNINGS:* Consult a physician for use in children under 12 years of age.* IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use.* KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.* Do not use if TAMPER EVIDENT seal is broken or missing.

Inactive Ingredient

INACTIVE INGREDIENTS: Ethyl Alcohol USP, Purified Water.

Otc - Questions

QUESTIONS & COMMENTS?Natural Creations, Inc. / Woodbine, IA 51579 / 712-647-1600

References

* The letters "HPUS" indicate the components in the product are officially monographed in the Homeopathic Pharmacopeia of the United States.** These statements have not been reviewed by the FDA. They are based on traditional homeopathic practice.LOT:

* Please review the disclaimer below.

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