Label: ADDITOX- trifolium pratense, xanthoxylum fraxineum, phytolacca decandra, arsenicum album, belladonna, chelidonium majus, lycopodium clavatum, phosphoricum acidum, aspartame, benzalkonium chloride, formalinum, methylene chloride, methylparaben, propylparaben, sodium benzoate, sodium citrate, titanium dioxide, zincum oxydatum liquid

  • NDC Code(s): 43857-0487-1
  • 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 July 18, 2018

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

  • ACTIVE INGREDIENTS:

    Trifolium Pratense 3X, Xanthoxylum Fraxineum 3X, Phytolacca Decandra 4X, Arsenicum Album 12X, Belladonna 12X, Chelidonium Majus 12X, Lycopodium Clavatum 12X, Phosphoricum Acidum 12X, Aspartame 30X, Benzalkonium Chloride 30X, Formalinum 30X, Methylene Chloride 30X, Methylparaben 30X, Propylparaben 30X, Sodium Benzoate 30X, Sodium Citrate 30X, Titanium Dioxide 30X.

  • INDICATIONS:

    For temporary relief of debility, exhaustion, exhaustion after slight exertion, and dysentery.

  • 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.

  • 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.

  • INDICATIONS:

    For temporary relief of debility, exhaustion, exhaustion after slight exertion, and dysentery.

  • INACTIVE INGREDIENTS:

    Demineralized Water, 25% Ethanol.

  • QUESTIONS:

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

    *For a complete list of Addisodes contact BioActive Nutritional, Inc.

  • PACKAGE LABEL DISPLAY:

    BIOActive Nutritional

    ADDITOX

    HOMEOPATHIC

    1 FL OZ (30 ml)

    Additox

  • INGREDIENTS AND APPEARANCE
    ADDITOX 
    trifolium pratense, xanthoxylum fraxineum, phytolacca decandra, arsenicum album, belladonna, chelidonium majus, lycopodium clavatum, phosphoricum acidum, aspartame, benzalkonium chloride, formalinum, methylene chloride, methylparaben, propylparaben, sodium benzoate, sodium citrate, titanium dioxide, zincum oxydatum liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0487
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828) (TRIFOLIUM PRATENSE FLOWER - UNII:4JS0838828) TRIFOLIUM PRATENSE FLOWER3 [hp_X]  in 1 mL
    ZANTHOXYLUM AMERICANUM BARK (UNII: A4KL1HMZ7T) (ZANTHOXYLUM AMERICANUM BARK - UNII:A4KL1HMZ7T) ZANTHOXYLUM AMERICANUM BARK3 [hp_X]  in 1 mL
    PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT4 [hp_X]  in 1 mL
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE12 [hp_X]  in 1 mL
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA12 [hp_X]  in 1 mL
    CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN) CHELIDONIUM MAJUS12 [hp_X]  in 1 mL
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE12 [hp_X]  in 1 mL
    PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN) PHOSPHORIC ACID12 [hp_X]  in 1 mL
    ASPARTAME (UNII: Z0H242BBR1) (ASPARTAME - UNII:Z0H242BBR1) ASPARTAME30 [hp_X]  in 1 mL
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE30 [hp_X]  in 1 mL
    FORMALDEHYDE (UNII: 1HG84L3525) (FORMALDEHYDE - UNII:1HG84L3525) FORMALDEHYDE30 [hp_X]  in 1 mL
    METHYLENE CHLORIDE (UNII: 588X2YUY0A) (METHYLENE CHLORIDE - UNII:588X2YUY0A) METHYLENE CHLORIDE30 [hp_X]  in 1 mL
    METHYLPARABEN (UNII: A2I8C7HI9T) (METHYLPARABEN - UNII:A2I8C7HI9T) METHYLPARABEN30 [hp_X]  in 1 mL
    PROPYLPARABEN (UNII: Z8IX2SC1OH) (PROPYLPARABEN - UNII:Z8IX2SC1OH) PROPYLPARABEN30 [hp_X]  in 1 mL
    SODIUM BENZOATE (UNII: OJ245FE5EU) (BENZOIC ACID - UNII:8SKN0B0MIM) SODIUM BENZOATE30 [hp_X]  in 1 mL
    SODIUM CITRATE (UNII: 1Q73Q2JULR) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) SODIUM CITRATE30 [hp_X]  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE30 [hp_X]  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION30 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43857-0487-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product07/18/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/18/2018
    Labeler - BioActive Nutritional, Inc. (624980496)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43857-0487) , api manufacture(43857-0487) , label(43857-0487) , pack(43857-0487)