Label: DIENCEPHALINUM- diencephalon 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 27, 2023

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  • ACTIVE INGREDIENT

    Active Ingredient

    DIENCEPHALINUM 200K GR

    DIENCEPHALINUM 30K GR

    DIENCEPHALINUM 4CH GR

  • PURPOSE

    Indications

    Helps to support nighttime rest and maintain normal
    sleep cycle

  • 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.

  • QUESTIONS

    QUESTIONS? 1-888-737-6925.

  • INDICATIONS & USAGE

    Indications

    Helps to support nighttime rest and maintain normal
    sleep cycle

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

  • PRINCIPAL DISPLAY PANEL

    62106-6988

    UNDA
    Do not use if label perforation is broken
    Homeopathic Remedy
    NDC : 62106-6988-4
    DIENCEPHALINUM
    Diencephalon
    140 granules
    Indications

    Helps to support nighttime rest and maintain normal
    sleep cycle

  • INGREDIENTS AND APPEARANCE
    DIENCEPHALINUM 
    diencephalon granule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62106-6988
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ORYCTOLAGUS CUNICULUS HYPOTHALAMUS (UNII: QMH532G890) (ORYCTOLAGUS CUNICULUS HYPOTHALAMUS - UNII:QMH532G890) ORYCTOLAGUS CUNICULUS HYPOTHALAMUS6 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    LACTOSE (UNII: J2B2A4N98G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62106-6988-410 in 1 CARTON03/19/201507/31/2024
    1140 in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/19/201507/31/2024
    Labeler - Seroyal USA (018361118)
    Establishment
    NameAddressID/FEIBusiness Operations
    SAN’UP401010287manufacture(62106-6988)
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