ADDITOX- phytolacca decandra, trifolium pratense, xanthoxylum fraxineum, 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 
BioActive Nutritional, Inc.

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.

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Drug Facts:

ACTIVE INGREDIENTS:

Phytolacca Decandra 3X, Trifolium Pratense 3X, Xanthoxylum Fraxineum 3X, 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.

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.

INDICATIONS:

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

QUESTIONS:

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

PACKAGE LABEL DISPLAY:

BIOActive Nutritional

ADDITOX

HOMEOPATHIC

1 FL OZ (30 ml)

Additox

ADDITOX 
phytolacca decandra, trifolium pratense, xanthoxylum fraxineum, 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:43857-0002
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT3 [hp_X]  in 1 mL
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
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE12 [hp_X]  in 1 mL
ATROPA BELLADONNA WHOLE (UNII: DSV74G1P2J) (ATROPA BELLADONNA WHOLE - UNII:DSV74G1P2J) ATROPA BELLADONNA WHOLE12 [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 OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE30 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43857-0002-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product02/08/201701/11/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic01/10/201301/11/2023
Labeler - BioActive Nutritional, Inc. (624980496)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(43857-0002) , api manufacture(43857-0002) , label(43857-0002) , pack(43857-0002)

Revised: 9/2018
Document Id: d585d468-0d66-4dbc-ac71-f910cff296b6
Set id: 7c89f3ea-cc43-4df4-b0c3-d51a583ed8b3
Version: 3
Effective Time: 20180906
 
BioActive Nutritional, Inc.