Label: STOMAPLEX- carduus marianus, gentiana lutea, sambucus nigra, senna (cassia angustifolia), stomach (bovine), arsenicum album, atropinum sulphuricum, carbo vegetabilis, lycopodium clavatum, nux vomica, phosphorus liquid

  • NDC Code(s): 43857-0090-1
  • Packager: BioActive Nutritional, 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 24, 2016

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  • ACTIVE INGREDIENTS:

    Carduus Marianus 3X, Gentiana Lutea 3X, Sambucus Nigra 3X, Senna (Cassia Angustifolia) 3X, Stomach (Bovine) 8X, Arsenicum Album 12X, Atropinum Sulphuricum 12X, Carbo Vegetabilis 12X, Lycopodium Clavatum 12X, Nux Vomica 12X, Phosphorus 12X.

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  • INDICATIONS:

    For temporary relief of aching in the stomach, nausea, flatulence, fullness in the abdomen, and indigestion.

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  • 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.

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  • 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 INGREDIENTS:

    Demineralized Water, 25% Ethanol.

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  • KEEP OUT OF REACH OF CHLDREN:

    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:

    For temporary relief of aching in the stomach, nausea, flatulence, fullness in the abdomen, and indigestion.

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  • QUESTIONS:

    Distributed by:
    BioActive Nutritional, Inc.
    1803 N. Wickham Rd.
    Melbourne, FL 32935
    bioactivenutritional.com

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  • PACKAGE LABEL DISPLAY:

    BIOActive Nutritional

    STOMAPLEX

    HOMEOPATHIC

    1 FL OZ (30 ml)

    Stomaplex

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  • INGREDIENTS AND APPEARANCE
    STOMAPLEX 
    carduus marianus, gentiana lutea, sambucus nigra, senna (cassia angustifolia), stomach (bovine), arsenicum album, atropinum sulphuricum, carbo vegetabilis, lycopodium clavatum, nux vomica, phosphorus liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:43857-0090
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SILYBUM MARIANUM SEED (UNII: U946SH95EE) (SILYBUM MARIANUM SEED - UNII:U946SH95EE) SILYBUM MARIANUM SEED 3 [hp_X]  in 1 mL
    GENTIANA LUTEA ROOT (UNII: S72O3284MS) (GENTIANA LUTEA ROOT - UNII:S72O3284MS) GENTIANA LUTEA ROOT 3 [hp_X]  in 1 mL
    SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U) (SAMBUCUS NIGRA FLOWERING TOP - UNII:CT03BSA18U) SAMBUCUS NIGRA FLOWERING TOP 3 [hp_X]  in 1 mL
    SENNA LEAF (UNII: AK7JF626KX) (SENNA LEAF - UNII:AK7JF626KX) SENNA LEAF 3 [hp_X]  in 1 mL
    TRIPE (UNII: C46FS57S0X) (TRIPE - UNII:C46FS57S0X) TRIPE 8 [hp_X]  in 1 mL
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE 12 [hp_X]  in 1 mL
    ATROPINE SULFATE (UNII: 03J5ZE7KA5) (ATROPINE - UNII:7C0697DR9I) ATROPINE SULFATE 12 [hp_X]  in 1 mL
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10) ACTIVATED CHARCOAL 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
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED 12 [hp_X]  in 1 mL
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 12 [hp_X]  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:43857-0090-1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 08/24/2016
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 02/19/2013
    Labeler - BioActive Nutritional, Inc. (624980496)
    Registrant - Apotheca Company (844330915)
    Establishment
    Name Address ID/FEI Business Operations
    Apotheca Company 844330915 manufacture(43857-0090) , api manufacture(43857-0090) , label(43857-0090) , pack(43857-0090)
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