NDC 17312-171 Fibromyalgia Relief

Bryonia Alba Root - Causticum - Loeselia Mexicana Whole - Magnesium Phosphate - Pulsatilla Vulgaris - Toxicodendron Pubescens Leaf - Valerian

NDC Product Code 17312-171

NDC CODE: 17312-171

Proprietary Name: Fibromyalgia Relief 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: Bryonia Alba Root - Causticum - Loeselia Mexicana Whole - Magnesium Phosphate - Pulsatilla Vulgaris - Toxicodendron Pubescens Leaf - Valerian 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)
Shape: DIAMOND (C48338)
Size(s):
10 MM
Imprint(s):
TRP
Score: 1

NDC Code Structure

  • 17312 - Trp Company

NDC 17312-171-14

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

NDC Product Information

Fibromyalgia Relief with NDC 17312-171 is a a human over the counter drug product labeled by Trp Company. The generic name of Fibromyalgia Relief is bryonia alba root - causticum - loeselia mexicana whole - magnesium phosphate - pulsatilla vulgaris - toxicodendron pubescens leaf - valerian. 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.

Fibromyalgia Relief 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.

  • LOESELIA MEXICANA WHOLE 6 [hp_C]/1
  • BRYONIA ALBA ROOT 6 [hp_C]/1
  • CAUSTICUM 6 [hp_C]/1
  • MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 6 [hp_C]/1
  • PULSATILLA VULGARIS 6 [hp_C]/1
  • TOXICODENDRON PUBESCENS LEAF 6 [hp_C]/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.
  • 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: 05-28-2020 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.

Fibromyalgia Relief 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

Bryonia HPUS 6C, 12C, 18C

Causticum HPUS 6C, 12C, 18C

Hoitzia HPUS 6C, 12C, 18C

Magnesia phosphorica HPUS 6C,12C,18C

Pulsatilla HPUS 6C,12C,18C

Rhus tox HPUS 6C,12C,18C

Valeriana officinalis HPUS 6C,12C,18C
HPUS indicates the active ingredients are in the Homeopathic Pharmacopoeia of the United States.

Otc - Purpose

Bryonia HPUS............................Difficulty moving, Stiff joints, acute soreness

Causticum HPUS.......................Muscle and nerve soreness

Hoitzia HPUS.............................Chronic discomfort, fatigue

Magnesia phosphorica HPUS ...Cramping, Fatigue

Pulsatilla HPUS .........................Migrating soreness

Rhus tox HPUS..........................Soft tissue discomfort

Valeriana officinalis HPUS..........Sleeplessness, Irritable bowels

Uses

• According to homeopathic indications these ingredients provide temporary relief from symptoms such as: • Muscle soreness • Fatigue • Nerve / soft tissue tenderness • Multiple tender points; after serious causes have been ruled out by a physician. * These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

Otc - Pregnancy Or Breast Feeding

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

Directions

  • Suitable for adults and children ages 2 and over. Children under the age of 2: Consult a physician before use.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. • Homeopathic remedies may not be effective for everyone. Individual results may vary. May take up to 60 days to see results.

Other Information

• Store at room temperature 15
o to 30
o C (59
o to 86
o F). • Keep bottle tightly closed. • 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 or contraindications. • Fibromyalgia Relief® Fast Dissolving TabletsTM are homeopathic dilutions, for details see www.thereliefproducts.com.

Inactive Ingredients

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

Do Not Use If Tamper Evident Seal Is Torn, Broken Or Missing.

Do not use if tamper evident seal is torn, broken or missing.

Stop Use

Stop use and ask a doctor if:Symptoms persist for more than 7 days or worsen.

Warnings

• A PHYSICIAN SHOULD ALWAYS BE CONSULTED TO RULE OUT SERIOUS CAUSES. • This product is intended to complement, not replace, standard medical treatment.• Initial worsening of symptoms may occur.

* Please review the disclaimer below.