Label: PMS- viburnum opulus bark, caulophyllum thalictroides root, anamirta cocculus seed, and gelsemium sempervirens root tablet, soluble

  • 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 February 26, 2014

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

  • PURPOSE

    Formerly Hyland's #24, Hyland's PMS is a traditional homeopathic formula for the relief of symptoms of painful menstruation, cramping and irritability associated with the menstrual period. Working without contraindications or side effects, Hyland's PMS stimulates your body's natural healing response to relieve symptoms. Hyland's PMS can be used in conjunction with other medications.

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  • Warnings

    Do not use if imprinted cap band is broken or missing.

    If symptoms persist for more than seven days or worsen, contact a licensed health care professional.

    As with any drug, if you are pregnant or nursing a baby, seek the advice of a licensed health care professional before using this product.

    Keep this and all medications out of the reach of children. In case of accidental overdose, contact a poison control center immediately.

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  • Indications

    Relief of symptoms of menstrual pain, cramping and irritability associated with the menstrual period.

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  • Directions

    Adults: Dissolve 2-3 tablets under tongue every 4 hours or as needed.

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  • FORMULA

    VIBURNUM OPULUS 2X, HPUS; CAULOPHYLLUM THALICTROIDES 3X, HPUS; COCCULUS INDICUS 3X, HPUS; GELSEMIUM SEMPERVIRENS 3X, HPUS IN A BASE OF LACTOSE, USP.

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  • QUESTIONS?

    CALL US: 800/624-9659

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  • PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Carton

    NDC 54973-2957-02

    Hyland's®

    HOMEOPATHIC

    PMS

    Natural Relief for Menstrual
    Cramps and Irritability.

    100
    TABLETS

    Principal Display Panel - 100 Tablet Bottle Carton
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  • INGREDIENTS AND APPEARANCE
    PMS 
    viburnum opulus bark, caulophyllum thalictroides root, anamirta cocculus seed, and gelsemium sempervirens root tablet, soluble
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-2957
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    VIBURNUM OPULUS BARK (UNII: T1UG6H6805) (VIBURNUM OPULUS BARK - UNII:T1UG6H6805) VIBURNUM OPULUS BARK 2 [hp_X]
    CAULOPHYLLUM THALICTROIDES ROOT (UNII: JTJ6HH6YEH) (CAULOPHYLLUM THALICTROIDES ROOT - UNII:JTJ6HH6YEH) CAULOPHYLLUM THALICTROIDES ROOT 3 [hp_X]
    ANAMIRTA COCCULUS SEED (UNII: 810258W28U) (ANAMIRTA COCCULUS SEED - UNII:810258W28U) ANAMIRTA COCCULUS SEED 3 [hp_X]
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT 3 [hp_X]
    Inactive Ingredients
    Ingredient Name Strength
    Lactose (UNII: J2B2A4N98G)  
    Product Characteristics
    Color WHITE Score no score
    Shape ROUND Size 5mm
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54973-2957-2 100 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED HOMEOPATHIC 09/26/1997
    Labeler - Hyland's (028570695)
    Establishment
    Name Address ID/FEI Business Operations
    Standard Homeopathic Company 008316655 MANUFACTURE(54973-2957)
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