Label: D-16- black cohosh, iris versicolor root, sanguinaria canadensis root, gelsemium sempervirens root, and spigelia anthelmia solution/ drops

  • 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 58264-0016-1

  • INDICATIONS

    Migraine, nervous headaches.

  • INGREDIENTS

    ACTIVE

    Cimicifuga racemosa 4x, Iris versicolor 2x, Sanguinaria canadensis 2x, Gelsemium sempervirens 3x, Spigelia anthelmia 4x

    INACTIVE

    20% alcohol in purified water.

  • 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 16

    HOMEOPATHIC
    STRESS FORMULA

    1 FL. OZ.

    PRINCIPAL DISPLAY PANEL - 1 FL. OZ. Bottle Label
  • INGREDIENTS AND APPEARANCE
    D-16 
    black cohosh, iris versicolor root, sanguinaria canadensis root, gelsemium sempervirens root, and spigelia anthelmia solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58264-0016
    Route of AdministrationSUBLINGUAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9) BLACK COHOSH4 [hp_X]  in 1 mL
    IRIS VERSICOLOR ROOT (UNII: X43D4L3DQC) (IRIS VERSICOLOR ROOT - UNII:X43D4L3DQC) IRIS VERSICOLOR ROOT2 [hp_X]  in 1 mL
    SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508) SANGUINARIA CANADENSIS ROOT2 [hp_X]  in 1 mL
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT3 [hp_X]  in 1 mL
    SPIGELIA ANTHELMIA (UNII: WYT05213GE) (SPIGELIA ANTHELMIA - UNII:WYT05213GE) SPIGELIA ANTHELMIA4 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58264-0016-129.57 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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