Label: FIBROMYALGIA RELIEF- bryonia alba root - causticum - loeselia mexicana whole - magnesium phosphate - pulsatilla vulgaris - toxicodendron pubescens leaf - valerian tablet, orally disintegrating

  • 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 May 28, 2020

If you are a consumer or patient please visit this version.

  • 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.

  • 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

    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.

  • Questions or Comments?

    Questions or Comments? 888-969-6855 www.thereliefproducts.com

  • PRINCIPAL DISPLAY PANEL

    CartonLabel

  • INGREDIENTS AND APPEARANCE
    FIBROMYALGIA RELIEF 
    bryonia alba root - causticum - loeselia mexicana whole - magnesium phosphate - pulsatilla vulgaris - toxicodendron pubescens leaf - valerian tablet, orally disintegrating
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17312-171
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LOESELIA MEXICANA WHOLE (UNII: XA8YCV5M3E) (LOESELIA MEXICANA WHOLE - UNII:XA8YCV5M3E) LOESELIA MEXICANA WHOLE6 [hp_C]
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT6 [hp_C]
    CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU) CAUSTICUM6 [hp_C]
    MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE6 [hp_C]
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS6 [hp_C]
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF6 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorwhiteScoreno score
    ShapeDIAMONDSize10mm
    FlavorImprint Code TRP
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17312-171-141 in 1 PACKAGE05/28/2020
    170 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/28/2020
    Labeler - TRP Company (105185719)