Label: AMOEBASODE - triticum aestivum, cajuputum, baptisia tinctoria, capsicum annuum, columbo, fragaria vesca, quassia amara, 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 May 4, 2011

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS:  Triticum aestivum 1X, Cajuputum 1X, Baptisia tinctoria 3X, Capsicum annuum 3X, Columbo 3X, Fragaria vesca 3X, Quassia amara 3X, Senna 3X, Absinthium 6X, Hepar bovinum 8X, 10X, 12X, 24X, Spleen 8X, 10X, 12X, 24X, Glandula suprarenalis bovinum 8X, 12X, 24X, 30X, Cinchona officinalis 12X, Lycopodium clavatum 12X, Amoeba 30X, 60X, 200X, 6C, 30C, Giardia 30X, 60X, 200X, 6C, 30C.

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  • PURPOSE

    INDICATIONS:  For temporary relief of symptoms of diarrhea, mucous in stools, and intestinal bloating.

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  • WARNINGS

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


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  • DOSAGE & ADMINISTRATION

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


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  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS:  Demineralized Water, 25% Ethanol.


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  • 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.

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  • INDICATIONS & USAGE

    INDICATIONS:  For temporary relief of symptoms of diarrhea, mucous in stools, and intestinal bloating.

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  • QUESTIONS

    Distributed by:

    SYNERGY FORMULAS, INC.

    251 West Road

    Campobello, SC 29322

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  • PRINCIPAL DISPLAY PANEL

    Synergy Formulas

    AMOEBASODE

    HOMEOPATHIC

    2 FL OZ (60 ml)

    Amoebasode

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  • INGREDIENTS AND APPEARANCE
    AMOEBASODE 
    triticum aestivum, cajuputum, baptisia tinctoria, capsicum annuum, columbo, fragaria vesca, quassia amara, liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:57520-0219
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    WHEAT (UNII: 4J2I0SN84Y) (WHEAT - UNII:4J2I0SN84Y) WHEAT 1 [hp_X]  in 1 mL
    BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU) BAPTISIA TINCTORIA ROOT 3 [hp_X]  in 1 mL
    CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG) CAPSICUM 3 [hp_X]  in 1 mL
    JATEORHIZA CALUMBA ROOT (UNII: V36I2B8LD5) (JATEORHIZA CALUMBA ROOT - UNII:V36I2B8LD5) JATEORHIZA CALUMBA ROOT 3 [hp_X]  in 1 mL
    FRAGARIA VESCA FRUIT (UNII: CG6IX3GCMU) (FRAGARIA VESCA FRUIT - UNII:CG6IX3GCMU) FRAGARIA VESCA FRUIT 3 [hp_X]  in 1 mL
    QUASSIA AMARA WOOD (UNII: S5249Q85HW) (QUASSIA AMARA WOOD - UNII:S5249Q85HW) QUASSIA AMARA WOOD 3 [hp_X]  in 1 mL
    SENNA LEAF (UNII: AK7JF626KX) (SENNA LEAF - UNII:AK7JF626KX) SENNA LEAF 3 [hp_X]  in 1 mL
    WORMWOOD (UNII: F84709P2XV) (WORMWOOD - UNII:F84709P2XV) WORMWOOD 6 [hp_X]  in 1 mL
    CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK 12 [hp_X]  in 1 mL
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE 12 [hp_X]  in 1 mL
    BEEF LIVER (UNII: W8N8R55022) (BEEF LIVER - UNII:W8N8R55022) BEEF LIVER 24 [hp_X]  in 1 mL
    BOS TAURUS ADRENAL GLAND (UNII: M2776SWB29) (BOS TAURUS ADRENAL GLAND - UNII:M2776SWB29) BOS TAURUS ADRENAL GLAND 30 [hp_X]  in 1 mL
    CAJUPUT OIL (UNII: J3TO6BUQ37) (CAJUPUT OIL - UNII:J3TO6BUQ37) CAJUPUT OIL 1 [hp_X]  in 1 mL
    SUS SCROFA SPLEEN (UNII: 92AMN5J79Y) (SUS SCROFA SPLEEN - UNII:92AMN5J79Y) SUS SCROFA SPLEEN 24 [hp_X]  in 1 mL
    AMOEBA PROTEUS (UNII: APR291GFYV) (AMOEBA PROTEUS - UNII:APR291GFYV) AMOEBA PROTEUS 30 [hp_C]  in 1 mL
    GIARDIA LAMBLIA (UNII: 89IEJ09R73) (GIARDIA LAMBLIA - UNII:89IEJ09R73) GIARDIA LAMBLIA 30 [hp_C]  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:57520-0219-1 60 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 04/12/2010
    Labeler - Apotheca Company (844330915)
    Establishment
    Name Address ID/FEI Business Operations
    Apotheca Company 844330915 manufacture
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