NDC 61096-1005 Digestivease

Arsenicum Alb, Calc Sulph, Carbo An, Carbo Veg, Cinchona, Hydrastis, Nox Vom, Ornithogalum, Pyrogenium, Silicea

NDC Product Code 61096-1005

NDC Code: 61096-1005

Proprietary Name: Digestivease 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: Arsenicum Alb, Calc Sulph, Carbo An, Carbo Veg, Cinchona, Hydrastis, Nox Vom, Ornithogalum, 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

  • 61096 - Eight And Company L.l.c
    • 61096-1005 - Digestivease

NDC 61096-1005-1

Package Description: 1 BOTTLE, SPRAY in 1 CARTON > 41 mL in 1 BOTTLE, SPRAY

NDC Product Information

Digestivease with NDC 61096-1005 is a a human over the counter drug product labeled by Eight And Company L.l.c. The generic name of Digestivease is arsenicum alb, calc sulph, carbo an, carbo veg, cinchona, hydrastis, nox vom, ornithogalum, pyrogenium, silicea. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Eight And Company L.l.c

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.

Digestivease 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.

  • ARSENIC TRIOXIDE 200 [hp_C]/41mL
  • CALCIUM SULFATE ANHYDROUS 200 [hp_C]/41mL
  • CARBO ANIMALIS 12 [hp_X]/41mL
  • ACTIVATED CHARCOAL 12 [hp_X]/41mL
  • CINCHONA OFFICINALIS BARK 200 [hp_C]/41mL
  • GOLDENSEAL 12 [hp_X]/41mL
  • STRYCHNOS NUX-VOMICA SEED 200 [hp_C]/41mL
  • ORNITHOGALUM UMBELLATUM 12 [hp_X]/41mL
  • RANCID BEEF 200 [hp_C]/41mL
  • SILICON DIOXIDE 12 [hp_X]/41mL

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.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • ALCOHOL (UNII: 3K9958V90M)
  • WATER (UNII: 059QF0KO0R)

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: Eight And Company L.l.c
Labeler Code: 61096
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: 04-24-2019 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.

Digestivease Product Label Images

Digestivease 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: Arsenicum alb 200C, Calc sulph 200C, Carbo an 12X, Carbo veg 12X, Cinchona 200C, Hydrastis 12X, Nox vomica 200C, Ornithogalum 12X, Pyrogenium 200, Silicea 12X

Warnings

Warnings: If symptoms persist or worsen, seek advice of physician. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. Contains alcohol, in case of overdose, get medical help or contact a Poison Control Center right away.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Dosage & Administration

  • Directions:Adults and children over 12: 2 sprays into the mouth each 30 minutes as needed for symptom relief the first day, 2 sprays 3 times a day thereafter.Under age 12: consult a health care professional.

Otc - Purpose

  • Temporarily relieves symptoms of gastric distress, including:nausea and food poisoningflatulenceindigestion and heartburnstomach cramps

Other Safety Information

Other Information: Do not use if the transparent seal around spray bottle is broken or missing.

Inactive Ingredient

Inactive Ingredients: Non-GMO glycerin v/v, norganic alcohol 20% v/v and purified water.

Indications & Usage

Temporarily relieves symptoms of gastric distress, including:° nausea and food poisoning° flatulence° indigestion and heartburn° stomach cramps° natural° gluten & lactose free° no artificial flavors or colors° no known negative side effects° no known negative drug interactions

* Please review the disclaimer below.

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