Label: EPIPHYSINUM- pineal gland granule

  • 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 September 28, 2023

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  • ACTIVE INGREDIENT

    Active Ingredients

    EPIPHYSINUM 200K GR

    EPIPHYSINUM 30K GR

    EPIPHYSINUM 4CH GR

    EPIPHYSINUM 7CH GR

  • PURPOSE

    Indications

    Helps maintain a healthy sleep pattern

  • WARNINGS

    Warning:
    If pregnant or breastfeeding, ask a health professional before use.
    Keep out of reach of children.
    In case of overdose, get medical help or contact a Poison Control Center right away.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OVERDOSAGE

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • INACTIVE INGREDIENT

    Inactive Ingredients
    Lactose,
    sucrose.

  • DOSAGE & ADMINISTRATION

    Directions
    Adults: Take five granules three times daily or as recommended by your healthcare practitioner.
    Children: Take three granules and follow adult directions.

  • INDICATIONS & USAGE

    Indications

    Helps maintain a healthy sleep pattern

    Directions
    Adults: Take five granules three times daily or as recommended by your healthcare practitioner.
    Children: Take three granules and follow adult directions.

  • QUESTIONS

    QUESTIONS? 1-888-737-6925.

  • PRINCIPAL DISPLAY PANEL

    62106-6991

    UNDA
    Do not use if label perforation is broken
    Homeopathic Remedy
    NDC : 62106-6991-4
    EPIPHYSINUM
    Pineal gland
    140 granules
    Indications

    Helps maintain a healthy sleep pattern

  • INGREDIENTS AND APPEARANCE
    EPIPHYSINUM 
    pineal gland granule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62106-6991
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ORYCTOLAGUS CUNICULUS BONE (UNII: GD946P479L) (ORYCTOLAGUS CUNICULUS BONE - UNII:GD946P479L) ORYCTOLAGUS CUNICULUS BONE6 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE (UNII: J2B2A4N98G)  
    SUCROSE (UNII: C151H8M554)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62106-6991-410 in 1 CARTON08/12/201507/31/2024
    1140 in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/12/201507/31/2024
    Labeler - Seroyal USA (018361118)
    Establishment
    NameAddressID/FEIBusiness Operations
    SAN’UP401010287manufacture(62106-6991)
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