Label: GASTROTONE- capsicum annuum, foeniculum vulgare, symphytum officinale, argentum nitricum, arsenicum album, magnesia phosphorica 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 June 12, 2013

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  • ACTIVE INGREDIENTS

    Capsicum Annuum 3X, Foeniculum Vulgare 3X, Symphytum Officinale 3X, Argentum Nitricum 12X, Arsenicum Album 12X, Magnesia Phosphorica 12X, Pulsatilla 12X

  • INDICATIONS

    For temporary relief of indigestion, flatulence, nausea, retching, vomitting after eating or drinking; minor burning pain in the stomach, and stomach irritable. 

  • 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 cool, dry place.

  • DIRECTIONS

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

  • INACTIVE INGREDIENTS

    Demineralized water, 25% Ethanol.

  • KEEP OUT OF REACH OF CHILDREN

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

  • INDICATIONS AND USAGE

    For temporary relief of indigestion, flatulence, nausea, retching, vomitting after eating or drinking; minor burning pain in the stomach, and stomach irritable.

  • QUESTIONS

    Distributed by:

    BIOACTIVE NUTRITIONAL

    Melbourne, FL 32935

    For Nutritional Information write:

    BioActive Nutritional, Inc.

    1803 N. Wickham Rd.

    Melbourne, FL 32935

  • PRINCIPAL DISPLAY PANEL

    BioActive Homeopathic

    GASTROTONE

    1 FL OZ (30 ml)

    Gastrotone

  • INGREDIENTS AND APPEARANCE
    GASTROTONE 
    capsicum annuum, foeniculum vulgare, symphytum officinale, argentum nitricum, arsenicum album, magnesia phosphorica liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0186
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG) CAPSICUM3 [hp_X]  in 1 mL
    FENNEL SEED (UNII: G3QC02NIE6) (FENNEL SEED - UNII:G3QC02NIE6) FENNEL SEED3 [hp_X]  in 1 mL
    COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT3 [hp_X]  in 1 mL
    SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A) SILVER NITRATE12 [hp_X]  in 1 mL
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE12 [hp_X]  in 1 mL
    MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE12 [hp_X]  in 1 mL
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS12 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43857-0186-130 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/12/2013
    Labeler - BioActive Nutritional, Inc. (624980496)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43857-0186) , api manufacture(43857-0186) , label(43857-0186) , pack(43857-0186)
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