Label: FOOD ADDITIVES- berberis vulgaris, chelidonium majus, trifolium pratense, glycyrrhiza glabra, lappa major, phytolacca decandra, rhamnus frangula, rhamnus purshiana, stillingia sylvatica, xanthoxylum fraxineum, arsenicum album, belladonna, lycopodium clavatum, natrum sulphuricum, phosphoricum acidum liquid

  • NDC Code(s): 43857-0168-1
  • 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 September 28, 2016

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

  • ACTIVE INGREDIENTS:

    Berberis Vulgaris 3X, Chelidonium Majus 3X, Trifolium Pratense 3X, Glycyrrhiza Glabra 4X, Lappa Major 4X, Phytolacca Decandra 4X, Rhamnus Frangula 4X, Rhamnus Purshiana 4X, Stillingia Sylvatica 4X, Xanthoxylum Fraxineum 4X, Arsenicum Album 12X, Belladonna 12X, Lycopodium Clavatum 12X, Natrum Sulphuricum 12X, Phosphoricum Acidum 12X

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  • INDICATIONS:

    For temporary relief of exhaustion, flatulence and mood swings. 

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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.

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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 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:

    For temporary relief of exhaustion, flatulence and mood swings.

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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

    FOOD ADDITIVES

    HOMEOPATHIC

    1 FL OZ (30 ml)

    Food Additives

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  • INGREDIENTS AND APPEARANCE
    FOOD ADDITIVES 
    berberis vulgaris, chelidonium majus, trifolium pratense, glycyrrhiza glabra, lappa major, phytolacca decandra, rhamnus frangula, rhamnus purshiana, stillingia sylvatica, xanthoxylum fraxineum, arsenicum album, belladonna, lycopodium clavatum, natrum sulphuricum, phosphoricum acidum liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:43857-0168
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (BERBERIS VULGARIS ROOT BARK - UNII:1TH8Q20J0U) BERBERIS VULGARIS ROOT BARK 3 [hp_X]  in 1 mL
    CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN) CHELIDONIUM MAJUS 3 [hp_X]  in 1 mL
    TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828) (TRIFOLIUM PRATENSE FLOWER - UNII:4JS0838828) TRIFOLIUM PRATENSE FLOWER 3 [hp_X]  in 1 mL
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) (GLYCYRRHIZA GLABRA - UNII:2788Z9758H) GLYCYRRHIZA GLABRA 4 [hp_X]  in 1 mL
    ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3) (ARCTIUM LAPPA ROOT - UNII:597E9BI3Z3) ARCTIUM LAPPA ROOT 4 [hp_X]  in 1 mL
    PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT 4 [hp_X]  in 1 mL
    FRANGULA ALNUS BARK (UNII: S2D77IH61R) (FRANGULA ALNUS BARK - UNII:S2D77IH61R) FRANGULA ALNUS BARK 4 [hp_X]  in 1 mL
    FRANGULA PURSHIANA BARK (UNII: 4VBP01X99F) (FRANGULA PURSHIANA BARK - UNII:4VBP01X99F) FRANGULA PURSHIANA BARK 4 [hp_X]  in 1 mL
    STILLINGIA SYLVATICA ROOT (UNII: QBR70R4FBK) (STILLINGIA SYLVATICA ROOT - UNII:QBR70R4FBK) STILLINGIA SYLVATICA ROOT 4 [hp_X]  in 1 mL
    ZANTHOXYLUM AMERICANUM BARK (UNII: A4KL1HMZ7T) (ZANTHOXYLUM AMERICANUM BARK - UNII:A4KL1HMZ7T) ZANTHOXYLUM AMERICANUM BARK 4 [hp_X]  in 1 mL
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE 12 [hp_X]  in 1 mL
    ATROPA BELLADONNA WHOLE (UNII: DSV74G1P2J) (ATROPA BELLADONNA WHOLE - UNII:DSV74G1P2J) ATROPA BELLADONNA WHOLE 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
    SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750) SODIUM SULFATE 12 [hp_X]  in 1 mL
    PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN) PHOSPHORIC ACID 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:43857-0168-1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 09/28/2016
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 05/16/2013
    Labeler - BioActive Nutritional, Inc. (624980496)
    Registrant - Apotheca Company (844330915)
    Establishment
    Name Address ID/FEI Business Operations
    Apotheca Company 844330915 manufacture(43857-0168) , api manufacture(43857-0168) , label(43857-0168) , pack(43857-0168)
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