NDC 44911-0079 Pms Tone

Angelica Archangelica, Cimicifuga Racemosa, Fucus Vesiculosus, Cuprum Metallicum, Lac Caninum, Lachesis Mutus

NDC Product Code 44911-0079

NDC CODE: 44911-0079

Proprietary Name: Pms Tone 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: Angelica Archangelica, Cimicifuga Racemosa, Fucus Vesiculosus, Cuprum Metallicum, Lac Caninum, Lachesis Mutus 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • Drug uses not available
  • This product is used to treat dryness inside the nose (nasal passages). It helps add moisture inside the nose to dissolve and soften thick or crusty mucus. In babies and young children with stuffy noses who cannot blow their noses, using this product helps to make the mucus easier to remove with a nasal bulb syringe. This helps relieve stuffiness and makes breathing easier. This product contains a purified gentle salt solution (also called saline or sodium chloride solution). It does not contain any medication.

NDC Code Structure

  • 44911 - Energique, Inc.

NDC 44911-0079-1

Package Description: 30 mL in 1 BOTTLE, DROPPER

NDC Product Information

Pms Tone with NDC 44911-0079 is a a human over the counter drug product labeled by Energique, Inc.. The generic name of Pms Tone is angelica archangelica, cimicifuga racemosa, fucus vesiculosus, cuprum metallicum, lac caninum, lachesis mutus. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Energique, Inc.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Pms Tone 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.

  • ANGELICA ARCHANGELICA ROOT 3 [hp_X]/mL
  • BLACK COHOSH 3 [hp_X]/mL
  • FUCUS VESICULOSUS 3 [hp_X]/mL
  • COPPER 12 [hp_X]/mL
  • CANIS LUPUS FAMILIARIS MILK 12 [hp_X]/mL
  • LACHESIS MUTA VENOM 12 [hp_X]/mL
  • LYCOPODIUM CLAVATUM SPORE 12 [hp_X]/mL
  • SODIUM CHLORIDE 12 [hp_X]/mL
  • PULSATILLA VULGARIS 12 [hp_X]/mL
  • SEPIA OFFICINALIS JUICE 12 [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)
  • ALCOHOL (UNII: 3K9958V90M)

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.
  • 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: Energique, Inc.
Labeler Code: 44911
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: 05-01-2013 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.

Pms Tone Product Label Images

Pms Tone 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

Active Ingredients

Angelica Archangelica 3X, Cimicifuga Racemosa 3X, Fucus Vesiculosus 3X, Cuprum Metallicum 12X, Lac Caninum 12X, Lachesis Mutus 12X, Lycopodium Clavatum 12X, Natrum Muriaticum 12X, Pulsatilla 12X, Sepia 12X

Indications

For temporary relief of fatigue, feelings of anxiety before menstruation, tender breasts, flushes of heat and headache.  **These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

Warnings

If pregnant or breast-feeding, ask a health professional before use.Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.Do not use if tamper evident seal is broken or missing. Store in a cool, dry place.

Directions

Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist, consult your health care professional. Consult a physician for use in children under 12 years of age.

Inactive Ingredients

Demineralized water, 20% Ethanol.

Keep Out Of Reach Of Children

In case of overdose, get medical help or contact a Poison Control Center right away.

Indications And Usage

For temporary relief of fatigue, feelings of anxiety before menstruation, tender breasts, flushes of heat and headache. **These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

Questions

Dist. by Energique, Inc.201 Apple BlvdWoodbine, IA 51579800-869-8078

* Please review the disclaimer below.