Label: STOMACH TINCTURE (gentiana lutea, sambucus nigra, senna, stomach- bovine, arsenicum album, atropinum sulphuricum, carbo vegetabilis 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 22, 2012

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS:

    Gentiana Lutea 3X,

    Sanbucus Nigra 3X,

    Senna 3X,

    Symphytum Officinale 3X,

    Stomach 6X,

    Arsenicum Album 12X,

    Atropinum Sulphuricum 12X,

    Carbo Vegetabilis 12X,

    Lycopodium Clavatum 12X,

    Nux Vomica 12X,

    Phosphorus 12X.

  • PURPOSE

    INDICATIONS:

    Provides specific sarcode support for the stomach. Gives temporary relilef of aching in the stomach, nausea, flatulence, and fullness in the abdomen.

  • WARNINGS

    WARNINGS:

    Keep out of reach of children. Incase of overdose, get medical help or contact a Posion Control Center right away. If pregnant or breast-feeding, ask a health professional before use. Do not use if tamper evident seal is broken or missing.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS:

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

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENT:

    Demineralized Water.

    25% Ethanol

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. Incase of overdose, get medical help or contact a Posion Control Center right away.

  • INDICATIONS & USAGE

    INDICATIONS:

    Provides specific sarcode support for the stomach. Gives temporary relilef of aching in the stomach, nausea, flatulence, and fullness in the abdomen.

  • QUESTIONS

    Distributed by:

    SYNERGY FORMULAS, INC.

    251 West Road

    Campobello, SC 29322

  • PRINCIPAL DISPLAY PANEL

    Synergy Formulas

    STOMACH TINCTURE

    HOMEOPATHIC

    2 FL oz (60 ml)

    Stomach Tincture

  • INGREDIENTS AND APPEARANCE
    STOMACH TINCTURE 
    gentiana lutea, sambucus nigra, senna, stomach (bovine), arsenicum album, atropinum sulphuricum, carbo vegetabilis liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43772-0001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GENTIANA LUTEA ROOT (UNII: S72O3284MS) (GENTIANA LUTEA ROOT - UNII:S72O3284MS) GENTIANA LUTEA ROOT3 [hp_X]  in 60 mL
    SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U) (SAMBUCUS NIGRA FLOWERING TOP - UNII:CT03BSA18U) SAMBUCUS NIGRA FLOWERING TOP3 [hp_X]  in 60 mL
    SENNA LEAF (UNII: AK7JF626KX) (SENNA LEAF - UNII:AK7JF626KX) SENNA LEAF3 [hp_X]  in 60 mL
    TRIPE (UNII: C46FS57S0X) (TRIPE - UNII:C46FS57S0X) TRIPE6 [hp_X]  in 60 mL
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE12 [hp_X]  in 60 mL
    ATROPINE SULFATE (UNII: 03J5ZE7KA5) (ATROPINE - UNII:7C0697DR9I) ATROPINE SULFATE12 [hp_X]  in 60 mL
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10) ACTIVATED CHARCOAL12 [hp_X]  in 60 mL
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE12 [hp_X]  in 60 mL
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED12 [hp_X]  in 60 mL
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS12 [hp_X]  in 60 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43772-0001-160 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/22/2012
    Labeler - Synergy Formulas (069579220)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43772-0001)
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