NDC 54973-3358 Menopause Plus Moisture

Atropa Belladonna, Berberis Vulgaris Root Bark, Caulophyllum Thalictroides Root, Black Cohosh, Graphite, Lachesis Muta Venom, Anemone Pulsatilla, Sepia Officinalis Juice, Delphinium Staphisagria Seed And Sulfur

NDC Product Code 54973-3358

NDC CODE: 54973-3358

Proprietary Name: Menopause Plus Moisture 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: Atropa Belladonna, Berberis Vulgaris Root Bark, Caulophyllum Thalictroides Root, Black Cohosh, Graphite, Lachesis Muta Venom, Anemone Pulsatilla, Sepia Officinalis Juice, Delphinium Staphisagria Seed And Sulfur 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 TO OFF-WHITE)
Shape: ROUND (C48348)
Size(s):
9 MM
Score: 1

NDC Code Structure

  • 54973 - Hyland's

NDC 54973-3358-1

Package Description: 1 KIT in 1 CARTON * 60 TABLET in 1 BOTTLE, PLASTIC (54973-3357-1) * 4 TABLET in 1 PACKET (54973-3357-2)

NDC Product Information

Menopause Plus Moisture with NDC 54973-3358 is a a human over the counter drug product labeled by Hyland's. The generic name of Menopause Plus Moisture is atropa belladonna, berberis vulgaris root bark, caulophyllum thalictroides root, black cohosh, graphite, lachesis muta venom, anemone pulsatilla, sepia officinalis juice, delphinium staphisagria seed and sulfur. The product's dosage form is kit and is administered via sublingual form.

Dosage Form: Kit - A packaged collection of related material.

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.

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)
  • ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
  • ACACIA (UNII: 5C5403N26O)
  • ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Sublingual - Administration beneath the tongue.

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: 06-01-2018 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.

Menopause Plus Moisture Product Label Images

Menopause Plus Moisture 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

Active ingredientsPurposeBelladonna 12X HPUShot flashes, night sweatsBerberis Vulgaris 12X HPUSvaginal dryness, pain, burning, irritationCaulophyllum 12X HPUSirritabilityCimicifuga Racemosa 12X HPUShot flashesGraphites 12X HPUSvaginal drynessLachesis 30X HPUShot flashesPulsatilla 12X HPUShot flashes, night sweatsSepia Officinalis 12X HPUSirritability, hot flashes, night sweatsStaphysagria 6X HPUSvaginal sorenessSulphur 12X HPUShot flashes, night sweats“HPUS” indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.

Uses

Temporarily relieves the symptoms of vaginal dryness and soreness, irritation, pain, burning with accompanying irritability, hot flashes, and night sweats experienced during menopause.

Otc - Pregnancy Or Breast Feeding

As with any drug, ask a doctor before use if pregnant or breast-feeding.

Otc - Do Not Use

Do not use: • more than directed. • if you have a known allergy to any ingredient in this product.

Do not use if imprinted tamper-evident bottle sleeve is broken or missing.

Otc - Ask Doctor

Consult a physician if • symptoms persist for more than 7 days or worsen. • symptoms are accompanied by abnormal vaginal discharge.

Otc - Keep Out Of Reach Of Children

Keep this and all medications out of reach of children. In case of accidental overdose, contact a medical professional or Poison Control Center immediately.

In Case Of Emergency

In case of emergency, contact a medical professional or Poison Control Center immediately. Doctor Wise by Hyland’s may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.

Directions

Adults: Take two tablets at onset of symptoms and repeat every four hours as needed.

Inactive Ingredients

Acacia Gum, Lactose

* Please review the disclaimer below.