Label: FIBROMYALGIA RELIEF- bryonia alba root - causticum - loeselia mexicana whole - magnesium phosphate - pulsatilla vulgaris - toxicodendron pubescens leaf - valerian tablet, orally disintegrating
- NDC Code(s): 17312-171-14
- Packager: TRP Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated April 9, 2024
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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,18CHPUS indicates the active ingredients are in the Homeopathic Pharmacopoeia of the United States.
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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.
- Keep out of reach of children
- PREGNANCY OR BREAST FEEDING
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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.
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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
- Do not use if tamper evident seal is torn, broken or missing.
- Stop use
- Warnings
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INGREDIENTS AND APPEARANCE
FIBROMYALGIA RELIEF
bryonia alba root - causticum - loeselia mexicana whole - magnesium phosphate - pulsatilla vulgaris - toxicodendron pubescens leaf - valerian tablet, orally disintegratingProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:17312-171 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LOESELIA MEXICANA WHOLE (UNII: XA8YCV5M3E) (LOESELIA MEXICANA WHOLE - UNII:XA8YCV5M3E) LOESELIA MEXICANA WHOLE 6 [hp_C] BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 6 [hp_C] CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU) CAUSTICUM 6 [hp_C] MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 6 [hp_C] PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS 6 [hp_C] TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF 6 [hp_C] Inactive Ingredients Ingredient Name Strength 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) Product Characteristics Color white Score no score Shape DIAMOND Size 10mm Flavor Imprint Code TRP Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:17312-171-14 1 in 1 PACKAGE 05/28/2020 1 70 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 05/28/2020 Labeler - TRP Company (105185719)