NDC 50845-0253 Stomach Distress

Bismuthum Subnitricum, Calcarea Sulphurica, Carbo Animalis, Carbo Vegetabilis, Cinchona Officinalis, Hydrastis Canadensis, Nux Vomica, Ornithogalum Umbellatum, Pyrogenium, Silicea,

NDC Product Code 50845-0253

NDC Code: 50845-0253

Proprietary Name: Stomach Distress 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: Bismuthum Subnitricum, Calcarea Sulphurica, Carbo Animalis, Carbo Vegetabilis, Cinchona Officinalis, Hydrastis Canadensis, Nux Vomica, Ornithogalum Umbellatum, Pyrogenium, Silicea, 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

  • 50845 - Liddell Laboratories, Inc.
    • 50845-0253 - Stomach Distress

NDC 50845-0253-1

Package Description: 30 mL in 1 BOTTLE, SPRAY

NDC Product Information

Stomach Distress with NDC 50845-0253 is a a human over the counter drug product labeled by Liddell Laboratories, Inc.. The generic name of Stomach Distress is bismuthum subnitricum, calcarea sulphurica, carbo animalis, carbo vegetabilis, cinchona officinalis, hydrastis canadensis, nux vomica, ornithogalum umbellatum, pyrogenium, silicea,. The product's dosage form is spray and is administered via oral form.

Labeler Name: Liddell Laboratories, Inc.

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

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.

Stomach Distress 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.

  • BISMUTH SUBNITRATE 200 [hp_C]/mL
  • CALCIUM SULFATE ANHYDROUS 200 [hp_C]/mL
  • CARBO ANIMALIS 12 [hp_X]/mL
  • ACTIVATED CHARCOAL 12 [hp_X]/mL
  • CINCHONA OFFICINALIS BARK 200 [hp_C]/mL
  • GOLDENSEAL 12 [hp_X]/mL
  • STRYCHNOS NUX-VOMICA SEED 200 [hp_C]/mL
  • ORNITHOGALUM UMBELLATUM 12 [hp_X]/mL
  • RANCID BEEF 200 [hp_C]/mL
  • SILICON DIOXIDE 12 [hp_X]/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: Liddell Laboratories, Inc.
Labeler Code: 50845
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: 04-12-2019 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: 12-31-2020 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.

Stomach Distress 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 Ingredients:

Bismuthum Subnitricum 200C, Calcarea sulphurica 200C, Carbo animalis 12X, Carbo vegetabilis 12X, Cinchona officinalis 200C, Hydrastis canadensis 12X, Nux vomica 200C, Ornithogalum umbellatum 12X, Pyrogenium 200C, Silicea 12X.

Uses:

May temporarily relieve these symptoms associated with stomach distress:• nausea• indigestion• stomach cramps• flatulence****Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Warnings:

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.Stop use and ask a doctor if symptoms persist, worsen or if new symptoms occur.Keep out of reach of children. In case of overdose, get medical help or call a Poison Control Center right away.If pregnant or breast feeding, ask a doctor before using product.Do not use if TAMPER EVIDENT seal around neck of bottle is missing or broken.OTHER INFORMATION: Store at room temperature.

Keep Out Of Reach Of Children:

Keep out of reach of children. In case of overdose, get medical help or call a Poison Control Center right away.

Directions:

Adults and children over 12: Spray twice under the tongue three times per day. For severe symptoms, dosage may be taken up to six times the first day.Children 12 and under: Consult a doctor prior to use.

Indications:

May temporarily relieve these symptoms associated with stomach distress:• nausea• indigestion• stomach cramps• flatulence****Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Inactive Ingredients:

Organic alcohol 20% v/v, Purified water.

Questions:

DIST. BY:LIDDELL LABORATORIES, INC.201 APPLE BLVD.WOODBINE, IA 51579WWW.LIDDELL.NET1-800-460-7733

Package Label Display:

ORAL SPRAYSLIDDELL LABORATORIESEST. 199410 SdStomachDistressMay relieve stomach distresssymptoms: Nausea, indigestion,stomach cramps +flatulence.HOMEOPATHICDOCTOR FORMULATEDReadily absorbed. Safe.No known side effects. Easy to use.1.0 FL OZ (30 ml)

* Please review the disclaimer below.

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