NDC 57556-004 Homeopathic Stress Mints

Agrimonia Eupatoria 3x, Matricaria Chamomilla 12x, Arnica Montana 12x, Phosphoric Acid 12x, Avena Sativa Flowering Top 3x, Strychnos Ignatii Seed 12x, Anemone Pulsatilla 12x, Aconitum Napellus 12x, Strychnos Nux Vomica Seed 12x

NDC Product Code 57556-004

NDC CODE: 57556-004

Proprietary Name: Homeopathic Stress Mints 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: Agrimonia Eupatoria 3x, Matricaria Chamomilla 12x, Arnica Montana 12x, Phosphoric Acid 12x, Avena Sativa Flowering Top 3x, Strychnos Ignatii Seed 12x, Anemone Pulsatilla 12x, Aconitum Napellus 12x, Strychnos Nux Vomica Seed 12x 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.

NDC Code Structure

  • 57556 - Historical Remedies Llp

NDC 57556-004-01

Package Description: 30 LOZENGE in 1 BOX

NDC Product Information

Homeopathic Stress Mints with NDC 57556-004 is a a human over the counter drug product labeled by Historical Remedies Llp. The generic name of Homeopathic Stress Mints is agrimonia eupatoria 3x, matricaria chamomilla 12x, arnica montana 12x, phosphoric acid 12x, avena sativa flowering top 3x, strychnos ignatii seed 12x, anemone pulsatilla 12x, aconitum napellus 12x, strychnos nux vomica seed 12x. The product's dosage form is lozenge and is administered via oral form.

Labeler Name: Historical Remedies Llp

Dosage Form: Lozenge - A solid preparation containing one or more medicaments, usually in a flavored, sweetened base which is intended to dissolve or disintegrate slowly in the mouth. A lollipop is a lozenge on a stick.

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.

Homeopathic Stress Mints 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.

  • AGRIMONIA EUPATORIA 3 [hp_X]/1
  • MATRICARIA CHAMOMILLA WHOLE 12 [hp_X]/1
  • ARNICA MONTANA WHOLE 12 [hp_X]/1
  • PHOSPHORIC ACID 12 [hp_X]/1
  • AVENA SATIVA FLOWERING TOP 3 [hp_X]/1
  • STRYCHNOS IGNATII SEED 12 [hp_X]/1
  • PULSATILLA VULGARIS WHOLE 12 [hp_X]/1
  • ACONITUM NAPELLUS 12 [hp_X]/1
  • STRYCHNOS NUX-VOMICA SEED 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.

  • DEXTROSE MONOHYDRATE (UNII: LX22YL083G)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • LEMON OIL (UNII: I9GRO824LL)

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: Historical Remedies Llp
Labeler Code: 57556
Marketing Category: UNAPPROVED DRUG OTHER - 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: 05-01-2020 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.

Homeopathic Stress Mints Product Label Images

Homeopathic Stress Mints 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

Indication

For the temporary relief of occasional stress that affects energy, digestion, nerves and emotions. These uses are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

Directions

Adults and children over 8: Dissolve one Stress Mints lozenge in mouth. Repeat every half hour as needed.

Warnings

If symptoms persist more than 7 days or worsen, consult a physician. Keep out of children’s reach. In case of overdose, get medical help or contact a poison control center right away. If pregnant or breast-feeding, ask a doctor before use.Do not use if shrink wrap is broken or missing.

Active Ingredients (Hpus)

Aconitum nap 12X, Agrimonia eup 3X, Arnica 12X, Avena 3X, Chamomilla 12X, Chamomilla 30X, Ignatia 12X, Nux vom 12X, Nux vom 30C, Pulsatilla 12X, Pulsatilla, 30C.

Inactive Ingredients

Dextrose Monohydrate, Magnesium Stearate, Maltodextrin, Natural and Organic Peppermint Flavors.4 calories per lozenge. 1 gram sugar per lozenge.No gluten added. Vegan.

* Please review the disclaimer below.