Fibromyalgia Relief Tablet, Orally Disintegrating
FDA Label NDC 17312-171

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Trp Company for the product Fibromyalgia Relief (NDC 17312-171). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, uses, otc - pregnancy or breast feeding, directions, other information, inactive ingredients, do not use if tamper evident seal is torn, broken or missing., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Otc - Active Ingredient

→ Otc - Purpose

→ Uses

→ Otc - Pregnancy Or Breast Feeding

→ Directions

→ Other Information

→ Inactive Ingredients

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

→ Stop Use

→ Warnings

→ Questions Or Comments?

→ Package Label.principal Display Panel

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.