NDC 79394-000 Digestion-bloating-gas

Triplex

NDC Product Code 79394-000

NDC CODE: 79394-000

Proprietary Name: Digestion-bloating-gas 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: Triplex 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):
2 MM
Imprint(s):
TX
Score: 1
Flavor(s):
ANISE (C73361)

NDC Code Structure

  • 79394 - L'envol Pharma

NDC 79394-000-01

Package Description: 24000 mg in 1 DOSE PACK

NDC Product Information

Digestion-bloating-gas with NDC 79394-000 is a a human over the counter drug product labeled by L'envol Pharma. The generic name of Digestion-bloating-gas is triplex. The product's dosage form is pill and is administered via oral form.

Labeler Name: L'envol Pharma

Dosage Form: Pill - A small, round solid dosage form containing a medicinal agent intended for oral administration.

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.

Digestion-bloating-gas 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.

  • FENNEL 2 mg/100mg
  • ANISE OIL 2 mg/100mg

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.

  • STAR ANISE OIL (UNII: 6RXP35EIRE)
  • STEVIA LEAF (UNII: 6TC6NN0876)
  • MENTHOL (UNII: L7T10EIP3A)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • HYDROGENATED AVOCADO OIL (UNII: JA69U4B4XI)

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: L'envol Pharma
Labeler Code: 79394
Marketing Category: UNAPPROVED DRUG OTHER - 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: 03-30-2020 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: 12-31-2021 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.

Digestion-bloating-gas Product Label Images

Digestion-bloating-gas 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 Ingredient(S)

Anise Dry Extract 2%Dry Fennel Extract 2%

Purpose

Light and Ease of Digestion

Use

Take 1 tablet 3-4 times a day when having issues with digestion

Warnings

No more than 6 tablets in a day.Keep away from children

Do Not Use

  • In children less than 2 months of ageon open skin wounds

Otc - When Using

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.


Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.


Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Otc - Stop Use

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If any issues occur get medical help or contact a Poison Control Center right away.

Directions

  • Take 1 tablet 3-4 times a day.Children under 12 years of age should not use product

Other Information

  • Store between 15-30C (59-86F)Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients

Magnesium stearate, non-hydrogenated vegetable oil, Menthol, Star Asine essential oil,Stevia Powder

* Please review the disclaimer below.