NDC 54973-2917 Ipecacuanha

Ipecac

NDC Product Code 54973-2917

NDC CODE: 54973-2917

Proprietary Name: Ipecacuanha 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: Ipecac 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):
BROWN (C48332)
Shape: ROUND (C48348)
Size(s):
9 MM
Score: 1

NDC Code Structure

NDC 54973-2917-4

Package Description: 250 TABLET in 1 BOTTLE, PLASTIC

NDC Product Information

Ipecacuanha with NDC 54973-2917 is a a human over the counter drug product labeled by Hyland's. The generic name of Ipecacuanha is ipecac. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Hyland's

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

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.

Ipecacuanha 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.

  • IPECAC 30 [hp_X]/1

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.

  • ACACIA (UNII: 5C5403N26O)
  • 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: Hyland's
Labeler Code: 54973
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: 01-01-1955 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.

Ipecacuanha Product Label Images

Ipecacuanha 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

IPECACUANHA 30X

Otc - Purpose

NAUSEA,VOMITING OR COUGH

Indications & Usage

NAUSEA,VOMITING OR COUGH

Otc - Do Not Use

Do not use if cap band is missing or broken.

Otc - Pregnancy Or Breast Feeding

If you are pregnant or nursing, consult a licensed health care professional before using this product.

Otc - Ask Doctor/Pharmacist

If symptoms persist for 7 days or worsen, contact a licensed practitioner.

Otc - Keep Out Of Reach Of Children

Keep this and all medicines out of the reach of children.

Otc - When Using

To be used according to label indications and/or standard homeopathic indications.

Directions

Adults: Dissolve 4 tablets under tongue 4 times a day. Children: 2 tablets as above.

Inactive Ingredient

In a base of Acacia Gum and Lactose N.F.

Questions?

800-624-9659

* Please review the disclaimer below.