NDC 68428-007 Flatulence

Ferula Assa-foetida Resin - Strychnos Ignatii Seed - Nutmeg

NDC Product Code 68428-007

NDC CODE: 68428-007

Proprietary Name: Flatulence 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: Ferula Assa-foetida Resin - Strychnos Ignatii Seed - Nutmeg 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 - WHITE)

NDC Code Structure

  • 68428 - Washington Homeopathic Products

NDC 68428-007-14

Package Description: 28 g in 1 BOTTLE, PLASTIC

NDC Product Information

Flatulence with NDC 68428-007 is a a human over the counter drug product labeled by Washington Homeopathic Products. The generic name of Flatulence is ferula assa-foetida resin - strychnos ignatii seed - nutmeg. The product's dosage form is pellet and is administered via oral form.

Labeler Name: Washington Homeopathic Products

Dosage Form: Pellet - A small sterile solid mass consisting of a highly purified drug (with or without excipients) made by the formation of granules, or by compression and molding.

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.

Flatulence 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.

  • FERULA ASSA-FOETIDA RESIN 6 [hp_C]/28g
  • STRYCHNOS IGNATII SEED 6 [hp_C]/28g
  • NUTMEG 6 [hp_C]/28g

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.

  • SUCROSE (UNII: C151H8M554)
  • LACTOSE (UNII: J2B2A4N98G)

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: Washington Homeopathic Products
Labeler Code: 68428
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: 07-13-2010 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Flatulence Product Label Images

Flatulence 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

ASAFOETIDA    6CIGNATIA    6CNUX MOSCH       6C

Uses

To relieve the symptoms of gas, sour stomach and heartburn. May include abdominal discomfort and bloating accompanied with frequent passing of gas.

Keep Out Of Reach Of Children

Keep this and all medicines out of reach of children.

Indications

Indications: ASAFOETIDA    FlatulenceIGNATIA    SadnessNUX MOSCH     Dry mouth

Stop Use And Ask Doctor

If symptoms persist/worsen or if pregnant/nursing, stop use and consult your practitioner.

Directions

Adults 2 pellets every 3 hours for 2 days. Then 2 pellets morning and night for 2 weeks. Children: 1 pellet. Repeat as necessary.

Inactive Ingredients

Sucrose/Lactose

* Please review the disclaimer below.