Label: D-58- adonis vernalis, convallaria majalis, helleborus niger root, digitalis, crataegus laevigata fruit, and drimia maritima bulb solution

  • 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 June 2, 2022

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  • SPL UNCLASSIFIED SECTION

    NDC 58264-0058-1

  • INDICATIONS

    Muscular weakness of the heart, edema of the legs.

  • INGREDIENTS

    ACTIVE

    Adonis vernalis 2x, Convallaria majalis 2x, Helleborus niger 4x, Digitalis purpurea 4x, Crataegus oxyacantha 1x, Scilla maritima 4x

    INACTIVE

    20% alcohol in purified water.

  • Rx CAUTION

    Federal law prohibits dispensing without a prescription.

  • SUGGESTED DOSAGE

    One dropper under tongue two times daily. Acute symptoms ½ dropper under tongue every 30 minutes for two hours.

  • STORAGE AND HANDLING

    SHAKE WELL

  • Warnings

    • Use only if cap seal is unbroken.

    • If pregnant or breastfeeding, ask a healthcare professional before use.

    • Keep this and all medication out of the reach of children.
  • SPL UNCLASSIFIED SECTION

    To be used according to standard homeopathic indications.

  • PRINCIPAL DISPLAY PANEL - 1 FL. OZ. Bottle Label

    DYNAMIC
    NUTRITIONAL
    ASSOCIATES, INC.

    D 58

    HOMEOPATHIC
    STRESS FORMULA

    1 FL. OZ.

    PRINCIPAL DISPLAY PANEL - 1 FL. OZ. Bottle Label
  • INGREDIENTS AND APPEARANCE
    D-58 
    adonis vernalis, convallaria majalis, helleborus niger root, digitalis, crataegus laevigata fruit, and drimia maritima bulb solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58264-0058
    Route of AdministrationSUBLINGUAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ADONIS VERNALIS (UNII: DX3ZNI25WK) (ADONIS VERNALIS - UNII:DX3ZNI25WK) ADONIS VERNALIS2 [hp_X]  in 1 mL
    CONVALLARIA MAJALIS (UNII: QHH4HVF5QE) (CONVALLARIA MAJALIS - UNII:QHH4HVF5QE) CONVALLARIA MAJALIS2 [hp_X]  in 1 mL
    HELLEBORUS NIGER ROOT (UNII: 608DGJ6815) (HELLEBORUS NIGER ROOT - UNII:608DGJ6815) HELLEBORUS NIGER ROOT4 [hp_X]  in 1 mL
    DIGITALIS (UNII: F1T8QT9U8B) (DIGITALIS - UNII:F1T8QT9U8B) DIGITALIS4 [hp_X]  in 1 mL
    CRATAEGUS LAEVIGATA FRUIT (UNII: D5RZ7MF1YF) (CRATAEGUS LAEVIGATA FRUIT - UNII:D5RZ7MF1YF) CRATAEGUS LAEVIGATA FRUIT1 [hp_X]  in 1 mL
    DRIMIA MARITIMA BULB (UNII: 3629601H5D) (DRIMIA MARITIMA BULB - UNII:3629601H5D) DRIMIA MARITIMA BULB4 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58264-0058-129.57 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product01/01/1990
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/01/1990
    Labeler - DNA Labs, Inc. (031784339)
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