Label: PMS RELIEF- aletris farinosa root, citrullus colocynthis fruit pulp, pulsatilla vulgaris, sanguinaria canadensis root, smilax ornata root, sepia officinalis juice, veratrum album root, liquid

  • 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 March 27, 2018

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  • Active Ingredients

    Aletris farinosa 9x, Colocynthis 6x, Pulsatilla 6x, Sanguinaria canad 6x, Sarsaparilla 9x, Sepia 6x, Veratrum album 6x

    Purpose

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  • Inactive ingredients:

    alcohol 20%, purified water.

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  • INDICATIONS & USAGE

    For temporary relief of pre-menstrual discomfort including cramps, tender breasts, irritability, hot flushes.

    These uses are based on traditional homeopathic practice. They have not been evauated by the FDA.

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  • Dosage:

    In general, 10 drops under the tongue 3 times daily. In acute conditions, 10 drops every 15 minutes. ´╗┐If nursing a baby or pregnant, seek the advice of a health professional before use.

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  • WARNINGS

    DO NOT USE

    IF BioE IMPRINTED SEAL ON NECK IS BROKEN

    If symptoms worsen or persist for more than 7 days, consult a physician.

    Keep out of the reach of children.

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  • Package Labeling:
  • INGREDIENTS AND APPEARANCE
    PMS RELIEF 
    aletris farinosa root, citrullus colocynthis fruit pulp, pulsatilla vulgaris, sanguinaria canadensis root, smilax ornata root, sepia officinalis juice, veratrum album root, liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:57293-4405
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ALETRIS FARINOSA ROOT (UNII: O021JGR97X) (ALETRIS FARINOSA ROOT - UNII:O021JGR97X) ALETRIS FARINOSA ROOT 9 [hp_X]  in 60 mL
    CITRULLUS COLOCYNTHIS FRUIT PULP (UNII: 23H32AOH17) (CITRULLUS COLOCYNTHIS FRUIT PULP - UNII:23H32AOH17) CITRULLUS COLOCYNTHIS FRUIT PULP 6 [hp_X]  in 60 mL
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) PULSATILLA VULGARIS 6 [hp_X]  in 60 mL
    SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508) SANGUINARIA CANADENSIS ROOT 6 [hp_X]  in 60 mL
    SMILAX ORNATA ROOT (UNII: 2H1576D5WG) (SARSAPARILLA - UNII:2H1576D5WG) SMILAX ORNATA ROOT 9 [hp_X]  in 60 mL
    SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE 6 [hp_X]  in 60 mL
    VERATRUM ALBUM ROOT (UNII: QNS6W5US1Z) (VERATRUM ALBUM ROOT - UNII:QNS6W5US1Z) VERATRUM ALBUM ROOT 6 [hp_X]  in 60 mL
    Inactive Ingredients
    Ingredient Name Strength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:57293-4405-2 60 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 04/13/1989
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 04/13/1989
    Labeler - BioEnergetics, Inc. (102847014)
    Registrant - BioEnergetics, Inc. (102847014)
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