NDC 57556-015 Ipecacuanha


NDC Product Code 57556-015

NDC 57556-015-02

Package Description: 14 g in 1 BOTTLE, GLASS

NDC Product Information

Ipecacuanha with NDC 57556-015 is a a human over the counter drug product labeled by Historical Remedies. The generic name of Ipecacuanha is ipecac. The product's dosage form is pellet and is administered via oral form.

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.

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.

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)

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: Historical Remedies
Labeler Code: 57556
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: 07-06-2021 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: 12-31-2022 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

Indications & Usage Section

Formulated for cough and chest congestion.

Dosage & Administration Section

Directions: Adults 4 pellets;
Children (4-12 years) 2 pellets; Dissolve under the tongue. Take every half hour as needed, or 4 times a day.

Otc - Active Ingredient Section

1% Ipecacuanha 12x

Otc - Purpose Section

Formulated for cough and chest congestion.

Inactive Ingredient Section

Inactive Ingredients: Organic beet-derived sucrose; gluten-free, lactose-free, non-GMO

Questions Section

Distributed by Historical Remedies; 122 S Wabasha, Saint Paul, MN 55107; 800-676-6654www.historicalremedies.com

Warnings Section

Warning: Consult a doctor if symptoms persist more than 3 days or worsen.
If pregnant or nursing, ask a doctor before use.
Keep out of reach of children. Do not use if tamper-evident band is missing or broken.

Otc - Pregnancy Or Breast Feeding Section

pregnant or breast-feeding, ask a doctor before use.

Otc - Keep Out Of Reach Of Children Section

Keep out of reach of children.

* Please review the disclaimer below.