Label: AMOEBASODE- triticum aestivum, cajuputum, baptisia tinctoria, capsicum annuum, fragaria vesca, frasera caroliniensis, quassia amara, senna liquid

  • NDC Code(s): 43772-0015-1
  • Packager: Synergy Formulas, Inc.
  • 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 13, 2013

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENTS:

    Triticum Aestivum 1X, Cajuputum 1X, Baptisia Tinctoria 3X, Capsicum Annuum 3X, Fragaria Vesca 3X, Frasera CAroliniensis 3X, Quassia Amara 3X, Senna 3X, Absinthium 6X, Hepar Bovine 8X, 10X, 12X, 24X, Spleen (Bovine) 8X, 10X, 12X, 24X, Glandula Suprarenalis Bovine 8X, 12X, 24X, 30X, Cinchona Officinalis 12X, Lycopodium Clavatum 12X, Amoeba Axis 8C, 15C, 30C, 100C, Giardia 9C, 15C, 30C, 100C.

  • INDICATIONS:

    For temporary relief of symptoms of diarrhea, mucus in stools, and intestinal bloating.

  • 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.

  • 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:

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

  • INDICATIONS:

    For temporary relief of symptoms of diarrhea, mucus in stools, and intestinal bloating.

  • QUESTIONS:

    Distributed by:

    SYNERGY FORMULAS, INC.

    251 West Road

    Campobello, SC 29322

  • PACKAGE DISPLAY LABEL:

    Synergy Formula

    AMOEBASODE

    HOMEOPATHIC

    2 FL OZ (60 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    AMOEBASODE 
    triticum aestivum, cajuputum, baptisia tinctoria, capsicum annuum, fragaria vesca, frasera caroliniensis, quassia amara, senna liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43772-0015
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRITICUM AESTIVUM WHOLE (UNII: 3C3Y389JBU) (TRITICUM AESTIVUM WHOLE - UNII:3C3Y389JBU) TRITICUM AESTIVUM WHOLE1 [hp_X]  in 1 mL
    CAJUPUT OIL (UNII: J3TO6BUQ37) (CAJUPUT OIL - UNII:J3TO6BUQ37) CAJUPUT OIL1 [hp_X]  in 1 mL
    BAPTISIA TINCTORIA (UNII: 5K1UO2888Y) (BAPTISIA TINCTORIA - UNII:5K1UO2888Y) BAPTISIA TINCTORIA3 [hp_X]  in 1 mL
    CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG) CAPSICUM3 [hp_X]  in 1 mL
    ALPINE STRAWBERRY (UNII: CG6IX3GCMU) (ALPINE STRAWBERRY - UNII:CG6IX3GCMU) ALPINE STRAWBERRY3 [hp_X]  in 1 mL
    FRASERA CAROLINIENSIS ROOT (UNII: 1JX35YMF5T) (FRASERA CAROLINIENSIS ROOT - UNII:1JX35YMF5T) FRASERA CAROLINIENSIS ROOT3 [hp_X]  in 1 mL
    QUASSIA AMARA WOOD (UNII: S5249Q85HW) (QUASSIA AMARA WOOD - UNII:S5249Q85HW) QUASSIA AMARA WOOD3 [hp_X]  in 1 mL
    SENNA LEAF (UNII: AK7JF626KX) (SENNA LEAF - UNII:AK7JF626KX) SENNA LEAF3 [hp_X]  in 1 mL
    WORMWOOD (UNII: F84709P2XV) (WORMWOOD - UNII:F84709P2XV) WORMWOOD6 [hp_X]  in 1 mL
    BEEF LIVER (UNII: W8N8R55022) (BEEF LIVER - UNII:W8N8R55022) BEEF LIVER8 [hp_X]  in 1 mL
    BOS TAURUS SPLEEN (UNII: 190Q9MB3U3) (BOS TAURUS SPLEEN - UNII:190Q9MB3U3) BOS TAURUS SPLEEN8 [hp_X]  in 1 mL
    BOS TAURUS ADRENAL GLAND (UNII: M2776SWB29) (BOS TAURUS ADRENAL GLAND - UNII:M2776SWB29) BOS TAURUS ADRENAL GLAND8 [hp_X]  in 1 mL
    CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK12 [hp_X]  in 1 mL
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE12 [hp_X]  in 1 mL
    AMOEBA PROTEUS (UNII: APR291GFYV) (AMOEBA PROTEUS - UNII:APR291GFYV) AMOEBA PROTEUS8 [hp_C]  in 1 mL
    GIARDIA LAMBLIA (UNII: 89IEJ09R73) (GIARDIA LAMBLIA - UNII:89IEJ09R73) GIARDIA LAMBLIA9 [hp_C]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43772-0015-160 mL in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/13/2013
    Labeler - Synergy Formulas, Inc. (069579220)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43772-0015) , api manufacture(43772-0015) , label(43772-0015) , pack(43772-0015)