NDC 54973-9113 Menopause

Amyl Nitrite, Sanguinaria Canadensis Root, And Lachesis Muta Venom

NDC Product Code 54973-9113

NDC CODE: 54973-9113

Proprietary Name: Menopause 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: Amyl Nitrite, Sanguinaria Canadensis Root, And Lachesis Muta Venom 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 - OFF WHITE)
Shape: ROUND (C48348)
Size(s):
9 MM
Score: 1

NDC Code Structure

NDC 54973-9113-2

Package Description: 100 TABLET, SOLUBLE in 1 BOTTLE, PLASTIC

NDC Product Information

Menopause with NDC 54973-9113 is a a human over the counter drug product labeled by Hyland's. The generic name of Menopause is amyl nitrite, sanguinaria canadensis root, and lachesis muta venom. The product's dosage form is tablet, soluble and is administered via oral form.

Labeler Name: Hyland's

Dosage Form: Tablet, Soluble - A solid dosage form that contains medicinal substances with or without suitable diluents and possesses the ability to dissolve in fluids.

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.

Menopause 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.

  • AMYL NITRITE 6 [hp_X]/1
  • SANGUINARIA CANADENSIS ROOT 3 [hp_X]/1
  • LACHESIS MUTA VENOM 12 [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.

  • 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: 03-01-1995 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.

Menopause Product Label Images

Menopause 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 - Purpose

Formerly Hyland's #13, Hyland's Menopause is a traditional homeopathic formula for the relief of symptoms of hot flashes, moodiness and irritability from the onset of menopause. Working without contraindications or side effects, Hyland's Menopause stimulates your body's natural healing response to relieve symptoms. Hyland's Menopause can be used in conjunction with other medications.

Otc - Do Not Use

Do not use if imprinted cap band is broken or missing. If symptoms persist for more than seven days or worsen, contact a licensed health care professional.

Otc - Pregnancy Or Breast Feeding

As with any drug, if your are pregnant or nursing a baby, seek the advice of a licensed health care professional before using this product.

Otc - Keep Out Of Reach Of Children

Keep this and all medications out of the reach of children. In case of accidental overdose, contact a poison control center immediately.

Indications

Relief of symptoms of hot flashes, moodiness and irritability due to onset of menopause.

Adults

Dissolve 2-3 tablets under tongue every 4 hours or as needed.

Formula

AMYL NITROSUM 6X, HPUS; SANGUINARIA CANADENSIS 3X, HPUS; LACHESIS MUTUS 12X, HPUS

Inactive Ingredient

IN A BASE OF LACTOSE, USP.

Other

HYLAND'S INC.


LOS ANGELES, CA 90061

Questions?

CALL US: 800/624-9659

* Please review the disclaimer below.