NDC 17312-022 Migraine Headache Therapy

Atropa Belladonna - Bryonia Alba Root - Black Cohosh - Arabica Coffee Bean - Nitroglycerin - Iris Versicolor Root - Sodium Chloride -

NDC Product Code 17312-022

NDC Code: 17312-022

Proprietary Name: Migraine Headache Therapy 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 - Bryonia Alba Root - Black Cohosh - Arabica Coffee Bean - Nitroglycerin - Iris Versicolor Root - Sodium Chloride - 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

  • 17312 - Trp Company

NDC 17312-022-14

Package Description: 1 BOTTLE in 1 PACKAGE > 70 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE

NDC Product Information

Migraine Headache Therapy with NDC 17312-022 is a a human over the counter drug product labeled by Trp Company. The generic name of Migraine Headache Therapy is atropa belladonna - bryonia alba root - black cohosh - arabica coffee bean - nitroglycerin - iris versicolor root - sodium chloride -. The product's dosage form is tablet, orally disintegrating and is administered via oral form.

Labeler Name: Trp Company

Dosage Form: Tablet, Orally Disintegrating - A solid dosage form containing medicinal substances which disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue.

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.

Migraine Headache Therapy 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.

  • ATROPA BELLADONNA 6 [hp_X]/1
  • BRYONIA ALBA ROOT 6 [hp_X]/1
  • BLACK COHOSH 6 [hp_X]/1
  • ARABICA COFFEE BEAN 3 [hp_X]/1
  • NITROGLYCERIN 12 [hp_X]/1
  • IRIS VERSICOLOR ROOT 6 [hp_X]/1
  • SODIUM CHLORIDE 6 [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.

  • MANNITOL (UNII: 3OWL53L36A)
  • SORBITOL (UNII: 506T60A25R)
  • CROSPOVIDONE (UNII: 68401960MK)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • COPOVIDONE (UNII: D9C330MD8B)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • LACTOSE (UNII: J2B2A4N98G)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)

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: Trp Company
Labeler Code: 17312
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: 12-01-2011 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: 12-31-2019 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.

Migraine Headache Therapy Product Label Images

Migraine Headache Therapy 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 - Active Ingredient

Active IngredientsPurposeBelladonna HPUS6x, 12xPounding, Throbbing HeadacheBryonia HPUS6x, 12x, 18xPressure Headache, VertigoCimicifuga racemosa HPUS6x, 12x, 18xLightheadednessCoffea crudaHPUS 3xIntolerable Pain, SensitivityGlonoinum HPUS12x, 18xBursting Headache, VertigoIris versicolor HPUS6x, 12x, 18xSick Headache, NauseaNatrum muriaticum HPUS6x, 12x, 18xBlinding Headache, Blurred Vision"HPUS" indicates the active ingredients are in the Homeopathic Pharmacopoeia of the United States.

Indications & Usage

Uses:*
According to homeopathic indications, these ingredients provide temporary relief for symptoms such as:
• Pressure
• Throbbing
• Light and noise sensitivity
after diagnosis by a physician.

*These statements are based upon traditional homeopathic practice.
They have not been reviewed by the Food and Drug Administration.

Warnings

  • Warnings:
  • USE ONLY AFTER DIAGNOSIS BY A PHYSICIAN
  • AND UNDER THE SUPERVISION OF A PHYSICIAN.
  • This product is intended to complement, not replace, standard medical treatment.Initial worsening of symptoms may occur.A physician should always be consulted to rule out serious causes.

  • In case of overdose, get medical help or contact a Poison Control Center right away.Stop use and ask a doctor if:You experience worsening symptoms.If symptoms last longer than 7 days.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Directions

  • Suitable for adults and children 12 years and above.Dissolve entire tablet under tongue.Do not chew or swallow whole.Take 1 tablet 3 times a day or as directed by a physician.Use up to 6 times a day as needed.Take at least 10 minutes before or at least 10 minutes after eating or drinking.Children under the age of 12: consult a physician before use.May take up to 60 days to see results.Homeopathic remedies may not be effective for everyone.

Other Information

  • There are no known contraindications.Active ingredients are micro-diluted in accordance with the Homeopathic Pharmacopoeia of the United States and are therefore non-toxic with no known side effects.Store in a cool dark location.
  • Migraine Headache Therapy™ Homeopathic Fast Dissolving Tablet are homeopathic
  • Dilutions: see www.thereliefproducts.com for details.

Inactive Ingredients

Advantol® 300, Lactose, Magnesium Stearate, Mannitol, Microcrystalline Cellulose.

* Please review the disclaimer below.