Label: MYOCARDIAL DROPS 5016- myocardial drops 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 August 15, 2019

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  • ACTIVE INGREDIENTS

    Cactus grandiflorus 3X
    Terminalia arjuna 3X
    Valeriana officinalis 3X
    Convallaria majalis 4X
    Veratrum album 4X
    Aurum muriaticum natronatum 5X
    Spigelia marilandica 5X
    Allium sativum 6X
    Crataegus oxyacantha 6X
    Digitalis purpurea 6X
    Heart 6X

  • QUESTIONS

    Professional Formulas

    PO Box 2034 Lake Oswego, OR 97035

  • INDICATIONS

    For the temporary relief of mild abdominal or chest pain, muscle cramps or spasms, exhaustion, general weakness, dizziness, or anxiousness.*

  • PURPOSE

    *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

  • WARNINGS

    Seek medical attention immediately for severe symptoms such as chest pressure or tightness with radiation of the pain to the jaw and down the arm, shortness of breath, or sweating. Keep out of the reach of children. In case of overdose, get medical help or contact a poison control center right away. If pregnant or breastfeeding, ask a healthcare professional before use.

    Keep out of the reach of children.

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

  • DIRECTIONS

    Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take 10 drops up to 3 times per day. Consult a physician for use in children under 12 years of age.

  • OTHER INFORMATION

    Tamper resistant. If seal is broken, do not use. After opening, close container tightly and store at room temperature away from heat.

  • INACTIVE INGREDIENTS

    20% ethanol, purified water.

  • LABEL

    Est 1985

    Professional Formulas

    Complementary Health

    Myocardial Drops

    Homeopathic Remedy

    2 FL. OZ. (59 mL)

    Label image

  • INGREDIENTS AND APPEARANCE
    MYOCARDIAL DROPS  5016
    myocardial drops liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63083-5016
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SELENICEREUS GRANDIFLORUS STEM (UNII: 7114SV0MYK) (SELENICEREUS GRANDIFLORUS STEM - UNII:7114SV0MYK) SELENICEREUS GRANDIFLORUS STEM3 [hp_X]  in 59 mL
    TERMINALIA ARJUNA WHOLE (UNII: 5T6S1T25EB) (TERMINALIA ARJUNA WHOLE - UNII:5T6S1T25EB) TERMINALIA ARJUNA WHOLE3 [hp_X]  in 59 mL
    VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN3 [hp_X]  in 59 mL
    CONVALLARIA MAJALIS (UNII: QHH4HVF5QE) (CONVALLARIA MAJALIS - UNII:QHH4HVF5QE) CONVALLARIA MAJALIS4 [hp_X]  in 59 mL
    VERATRUM ALBUM ROOT (UNII: QNS6W5US1Z) (VERATRUM ALBUM ROOT - UNII:QNS6W5US1Z) VERATRUM ALBUM ROOT4 [hp_X]  in 59 mL
    SODIUM TETRACHLOROAURATE (UNII: 7FT6QUT299) (TETRACHLOROAURATE ION - UNII:ZNL6IP5PJX) SODIUM TETRACHLOROAURATE5 [hp_X]  in 59 mL
    SPIGELIA MARILANDICA ROOT (UNII: 467D26HS0B) (SPIGELIA MARILANDICA ROOT - UNII:467D26HS0B) SPIGELIA MARILANDICA ROOT5 [hp_X]  in 59 mL
    GARLIC (UNII: V1V998DC17) (GARLIC - UNII:V1V998DC17) GARLIC6 [hp_X]  in 59 mL
    HAWTHORN LEAF WITH FLOWER (UNII: 6OM09RPY36) (HAWTHORN LEAF WITH FLOWER - UNII:6OM09RPY36) HAWTHORN LEAF WITH FLOWER6 [hp_X]  in 59 mL
    DIGITALIS (UNII: F1T8QT9U8B) (DIGITALIS - UNII:F1T8QT9U8B) DIGITALIS6 [hp_X]  in 59 mL
    BEEF HEART (UNII: P47W069U38) (BEEF HEART - UNII:P47W069U38) BEEF HEART6 [hp_X]  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63083-5016-259 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product08/15/1985
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/15/1984
    Labeler - Professional Complementary Health Formulas (167339027)
    Registrant - Natural Pharmaceutical Manufacturing LLC (015624923)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natural Pharmaceutical Manufacturing LLC015624923manufacture(63083-5016)