Label: AM-5- helleborus niger whole, magnesium phosphate, dibasic trihydrate, and bos taurus bile 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 1, 2022

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  • SPL UNCLASSIFIED SECTION

    NDC 58264-0344-1

  • INDICATIONS

    Regulates energy flow in the large intestine meridian.

  • INGREDIENTS

    Helleborus niger 8x, Magnesia phosphorica 8x, Fel tauri 12x, aa partes, 20% alcohol in purified water.

  • SUGGESTED DOSAGE

    5 to 10 drops twice a day, meridian energy excess 1 to 5 drops t.i.d, meridian lacking in energy 10 to 20 drops t.i.d.

  • STORAGE AND HANDLING

    SHAKE WELL

  • Warnings

    • Use only if cap seal is unbroken.

    • As with drugs if you are pregnant or nursing a baby seek professional advice before using this product.

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

    To be used according to standard homeopathic indications.

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

    DYNAMIC
    NUTRITIONAL
    ASSOCIATES, INC.

    AM-5

    LARGE INTESTINE

    ACUPUNCTURE MERIDIAN

    1 FL. OZ.

    Principal Display Panel - 1 FL. OZ. Bottle Label
  • INGREDIENTS AND APPEARANCE
    AM-5 
    helleborus niger whole, magnesium phosphate, dibasic trihydrate, and bos taurus bile solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58264-0344
    Route of AdministrationSUBLINGUAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HELLEBORUS NIGER WHOLE (UNII: H0NO2VNJ61) (HELLEBORUS NIGER WHOLE - UNII:H0NO2VNJ61) HELLEBORUS NIGER WHOLE8 [hp_X]  in 1 mL
    MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE8 [hp_X]  in 1 mL
    BOS TAURUS BILE (UNII: ET3651ZLOU) (BOS TAURUS BILE - UNII:ET3651ZLOU) BOS TAURUS BILE12 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58264-0344-129.57 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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