Label: APIZELEN- alfalfa, aralia quinquefolia, avena sativa, beta vulgaris, calendula officinalis, chelidonium majus, echinacea (angustifolia), natrum muriaticum, oxalis acetosella, paloondo, phytolacca decandra, trifolium pratense, urtica dioica, viscum album, cobalt acetate, cobalt gluconate, copper gluconate, cuprum aceticum, glutathione, magnesium gluconicum dihydricum, ganoderma lucidum, ubidecarenonum, argentum metallicum, germanium metallicum liquid

  • NDC Code(s): 43857-0490-1
  • 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 11, 2018

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

  • ACTIVE INGREDIENTS:

    Alfalfa 1C, Aralia Quinquefolia 2C, Avena Sativa 1C, Beta Vulgaris 2C, Calendula Officinalis 2C, Chelidonium Majus 1C, Echinacea (Angustifolia) 2C, Natrum Muriaticum 2C, Oxalis Acetosella 2C, Paloondo 2C, Phytolacca Decandra 2C, Trifolium Pratense 2C, Urtica Dioica 2C, Viscum Album 2C, Cobalt Acetate 3C, Cobalt Gluconate 3C, Copper Gluconate 3C, Cuprum Aceticum 3C, Glutathione 3C, Magnesium Gluconicum Dihydricum 3C, Ganoderma Lucidum 5C, Ubidecarenonum 5C, Argentum Metallicum 8C, Germanium Metallicum 8C.

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  • INDICATIONS:

    For temporary relief of fatigue, indigestion, and flatulent colic.

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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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  • 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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  • DIRECTIONS:

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

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  • INDICATIONS:

    For temporary relief of fatigue, indigestion, and flatulent colic.

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  • INACTIVE INGREDIENTS:

    Demineralized Water, 25% Ethanol

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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

    APIZELEN

    HOMEOPATHIC

    1 FL OZ (30 ml)

    Apizelen

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  • INGREDIENTS AND APPEARANCE
    APIZELEN 
    alfalfa, aralia quinquefolia, avena sativa, beta vulgaris, calendula officinalis, chelidonium majus, echinacea (angustifolia), natrum muriaticum, oxalis acetosella, paloondo, phytolacca decandra, trifolium pratense, urtica dioica, viscum album, cobalt acetate, cobalt gluconate, copper gluconate, cuprum aceticum, glutathione, magnesium gluconicum dihydricum, ganoderma lucidum, ubidecarenonum, argentum metallicum, germanium metallicum liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:43857-0490
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ALFALFA (UNII: DJO934BRBD) (ALFALFA - UNII:DJO934BRBD) ALFALFA 2 [hp_C]  in 1 mL
    AMERICAN GINSENG (UNII: 8W75VCV53Q) (AMERICAN GINSENG - UNII:8W75VCV53Q) AMERICAN GINSENG 2 [hp_C]  in 1 mL
    AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP 2 [hp_C]  in 1 mL
    BETA VULGARIS (UNII: 4G174V5051) (BETA VULGARIS - UNII:4G174V5051) BETA VULGARIS 2 [hp_C]  in 1 mL
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP 2 [hp_C]  in 1 mL
    CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN) CHELIDONIUM MAJUS 2 [hp_C]  in 1 mL
    ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA 2 [hp_C]  in 1 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 2 [hp_C]  in 1 mL
    OXALIS ACETOSELLA LEAF (UNII: U1W3U02EW0) (OXALIS ACETOSELLA LEAF - UNII:U1W3U02EW0) OXALIS ACETOSELLA LEAF 2 [hp_C]  in 1 mL
    LARREA TRIDENTATA LEAF (UNII: PK0TXD049P) (LARREA TRIDENTATA LEAF - UNII:PK0TXD049P) LARREA TRIDENTATA LEAF 2 [hp_C]  in 1 mL
    PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT 2 [hp_C]  in 1 mL
    TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828) (TRIFOLIUM PRATENSE FLOWER - UNII:4JS0838828) TRIFOLIUM PRATENSE FLOWER 2 [hp_C]  in 1 mL
    URTICA DIOICA (UNII: 710FLW4U46) (URTICA DIOICA - UNII:710FLW4U46) URTICA DIOICA 2 [hp_C]  in 1 mL
    VISCUM ALBUM FRUITING TOP (UNII: BK9092J5MP) (VISCUM ALBUM FRUITING TOP - UNII:BK9092J5MP) VISCUM ALBUM FRUITING TOP 2 [hp_C]  in 1 mL
    COBALTOUS ACETATE (UNII: 3XC4P44U7E) (COBALTOUS CATION - UNII:AI1MR454XG) COBALTOUS ACETATE 3 [hp_C]  in 1 mL
    COBALTOUS GLUCONATE (UNII: 26SK597UWV) (COBALTOUS CATION - UNII:AI1MR454XG) COBALTOUS GLUCONATE 3 [hp_C]  in 1 mL
    COPPER GLUCONATE (UNII: RV823G6G67) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION 3 [hp_C]  in 1 mL
    CUPRIC ACETATE (UNII: 39M11XPH03) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC ACETATE 3 [hp_C]  in 1 mL
    GLUTATHIONE (UNII: GAN16C9B8O) (GLUTATHIONE - UNII:GAN16C9B8O) GLUTATHIONE 3 [hp_C]  in 1 mL
    MAGNESIUM GLUCONATE (UNII: T42NAD2KHC) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM GLUCONATE 3 [hp_C]  in 1 mL
    REISHI (UNII: TKD8LH0X2Z) (REISHI - UNII:TKD8LH0X2Z) REISHI 5 [hp_C]  in 1 mL
    UBIDECARENONE (UNII: EJ27X76M46) (UBIDECARENONE - UNII:EJ27X76M46) UBIDECARENONE 5 [hp_C]  in 1 mL
    SILVER (UNII: 3M4G523W1G) (SILVER - UNII:3M4G523W1G) SILVER 8 [hp_C]  in 1 mL
    GERMANIUM (UNII: 00072J7XWS) (GERMANIUM - UNII:00072J7XWS) GERMANIUM 8 [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:43857-0490-1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 09/10/2018
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 09/10/2018
    Labeler - BioActive Nutritional, Inc. (624980496)
    Registrant - Apotheca Company (844330915)
    Establishment
    Name Address ID/FEI Business Operations
    Apotheca Company 844330915 manufacture(43857-0490) , api manufacture(43857-0490) , label(43857-0490) , pack(43857-0490)
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