NDC 69008-2001 Aletris Cordial

Aletris Cordial

NDC Product Code 69008-2001

NDC Product Information

Aletris Cordial with NDC 69008-2001 is a a human over the counter drug product labeled by Warsan Homoeopathic. The generic name of Aletris Cordial is aletris cordial. The product's dosage form is solution/ drops and is administered via oral form.

Labeler Name: Warsan Homoeopathic

Dosage Form: Solution/ Drops - A solution which is usually administered in a drop-wise fashion.

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.

Aletris Cordial 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.

  • CAULOPHYLLUM THALICTROIDES ROOT 1 [hp_X]/mL
  • BLACK COHOSH 1 [hp_X]/mL
  • FRAXINUS AMERICANA BARK 1 [hp_X]/mL
  • CHAMAELIRIUM LUTEUM ROOT 1 [hp_X]/mL
  • ALETRIS FARINOSA ROOT 1 [hp_X]/mL
  • ANEMONE PULSATILLA 1 [hp_X]/mL
  • VIBURNUM OPULUS BARK 1 [hp_X]/mL
  • ZANTHOXYLUM AMERICANUM BARK 1 [hp_X]/mL
  • SEPIA OFFICINALIS JUICE 1 [hp_X]/mL
  • SARACA INDICA BARK 1 [hp_X]/mL
  • HYDRASTIS CANADENSIS WHOLE 1 [hp_X]/mL

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.

  • WATER (UNII: 059QF0KO0R)
  • SORBITOL (UNII: 506T60A25R)

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: Warsan Homoeopathic
Labeler Code: 69008
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: 07-02-2019 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.

Aletris Cordial Product Label Images

Aletris Cordial 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 - Keep Out Of Reach Of Children

Keep out of reach of children.

Warnings

Stop use and ask doctor if symptoms worsen or persist longer than 7 days.If pregnant or breast-feeding, ask health professional before use.Do not use if tamper evident seal is missing or broken.

Otc - Active Ingredient

Aletris Farinosa 1X

Jonesia Asoca 1X

Caulophyllum 1X

Cimifuga Racemosa 1X

Fraxnius Americana 1X

Helonia Dioica 1X

Hydrastis Candensis 1X

Pulsatilla 1X

Viburnum Opulus 1X

Xanothoxylum

Sepia 1X

Otc - Purpose

Temporary relief from irregular, painful periods and other disorders including scanty flow, premature periods, delayed periods, premenstrual pain, absence of menstruation, bearing down pain.

Inactive Ingredient

Purified WaterSorbitol

Dosage & Administration

Adults and adolecents 12 years and older: One tablespoon three times daily as needed.Children under the age of 12: Consult doctor prior to use.

Indications & Usage

Temporary relief from irregular, painful periods and other disorders including scanty flow, premature periods, delayed periods, premenstrual pain, absence of menstruation, bearing down pain.

* Please review the disclaimer below.

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