Label: CARDIOTONE (adenosinum triphosphoricum dinatrum, cactus grandiflorus, convallaria majalis, heart (suis), magnesium gluconate, potassium gluconate, thyroidinum- suis, ubidecarenonum, germanium sesquioxide, strophanthus hispidus, adonis vernalis, digitalis purpurea liquid

  • 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 April 2, 2019

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  • ACTIVE INGREDIENTS:

    Adenosinum Triphosphoricum Dinatrum 6X, Cactus Grandiflorus 6X, Convallaria Majalis 6X, Heart (Suis) 6X, Magnesium Gluconate 6X, Potassium Gluconate 6X, Thyroidinum (Suis) 6X, Ubidecarenonum 6X, Germanium Sesquioxide 8X, Strophanthus Hispidus 10X, Adonis Vernalis 12X, Digitalis Purpurea 12X.

  • INDICATIONS:

    For temporary relief of difficulty breathing after walking, tiredness, feeling as if you can't breathe, and profuse perspiration.

  • WARNINGS:

    If pregnant or breast-feeding, ask a health care professional before use.

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

    Do not use if tamper evident seal is broken or missing.

    Store in a cool, dry place.

  • KEEP OUT OF REACH OF CHILDREN:

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

  • DIRECTIONS:

    10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

  • INDICATIONS:

    For temporary relief of difficulty breathing after walking, tiredness, feeling as if you can't breathe, and profuse perspiration.

  • INACTIVE INGREDIENTS:

    Demineralized Water, 25% Ethanol

  • QUESTIONS:

    Distributed by:
    BioActive Nutritional, Inc.
    1803 N. Wickham Rd.
    Melbourne, FL 32935
    bioactivenutritional.com

  • PACKAGE LABEL DISPLAY:

    BIOActive Nutritional

    CARDIOTONE

    HOMEOPATHIC

    1 FL OZ (30 ml)

    Cardiotone

  • INGREDIENTS AND APPEARANCE
    CARDIOTONE 
    adenosinum triphosphoricum dinatrum, cactus grandiflorus, convallaria majalis, heart (suis), magnesium gluconate, potassium gluconate, thyroidinum (suis), ubidecarenonum, germanium sesquioxide, strophanthus hispidus, adonis vernalis, digitalis purpurea liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0512
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ADENOSINE TRIPHOSPHATE DISODIUM (UNII: 5L51B4DR1G) (ADENOSINE TRIPHOSPHATE - UNII:8L70Q75FXE) ADENOSINE TRIPHOSPHATE DISODIUM6 [hp_X]  in 1 mL
    SELENICEREUS GRANDIFLORUS STEM (UNII: 7114SV0MYK) (SELENICEREUS GRANDIFLORUS STEM - UNII:7114SV0MYK) SELENICEREUS GRANDIFLORUS STEM6 [hp_X]  in 1 mL
    CONVALLARIA MAJALIS (UNII: QHH4HVF5QE) (CONVALLARIA MAJALIS - UNII:QHH4HVF5QE) CONVALLARIA MAJALIS6 [hp_X]  in 1 mL
    PORK HEART (UNII: X876KJM95L) (PORK HEART - UNII:X876KJM95L) PORK HEART6 [hp_X]  in 1 mL
    MAGNESIUM GLUCONATE (UNII: T42NAD2KHC) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM GLUCONATE6 [hp_X]  in 1 mL
    POTASSIUM GLUCONATE (UNII: 12H3K5QKN9) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM GLUCONATE6 [hp_X]  in 1 mL
    SUS SCROFA THYROID (UNII: 6RV024OAUQ) (SUS SCROFA THYROID - UNII:6RV024OAUQ) SUS SCROFA THYROID6 [hp_X]  in 1 mL
    UBIDECARENONE (UNII: EJ27X76M46) (UBIDECARENONE - UNII:EJ27X76M46) UBIDECARENONE6 [hp_X]  in 1 mL
    GERMANIUM SESQUIOXIDE (UNII: 96WE91N25T) (GERMANIUM SESQUIOXIDE - UNII:96WE91N25T) GERMANIUM SESQUIOXIDE8 [hp_X]  in 1 mL
    STROPHANTHUS HISPIDUS SEED (UNII: MO892VI77K) (STROPHANTHUS HISPIDUS SEED - UNII:MO892VI77K) STROPHANTHUS HISPIDUS SEED10 [hp_X]  in 1 mL
    ADONIS VERNALIS (UNII: DX3ZNI25WK) (ADONIS VERNALIS - UNII:DX3ZNI25WK) ADONIS VERNALIS12 [hp_X]  in 1 mL
    DIGITALIS (UNII: F1T8QT9U8B) (DIGITALIS - UNII:F1T8QT9U8B) DIGITALIS12 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43857-0512-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product04/02/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/02/2019
    Labeler - BioActive Nutritional, Inc. (624980496)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43857-0512) , api manufacture(43857-0512) , label(43857-0512) , pack(43857-0512)
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