NDC | 43857-0002-1 |
Set ID | 7c89f3ea-cc43-4df4-b0c3-d51a583ed8b3 |
Category | HUMAN OTC DRUG LABEL |
Packager | BioActive Nutritional, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
- 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.
Close - INDICATIONS:
For temporary relief of debility, exhaustion, exhaustion after slight exertion, and dysentery.
Close - 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.
Close - DIRECTIONS:
10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.
Close - INACTIVE INGREDIENTS:
- 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.
Close - INDICATIONS:
For temporary relief of debility, exhaustion, exhaustion after slight exertion, and dysentery.
Close - QUESTIONS:
Distributed by:
Close
BioActive Nutritional, Inc.
1803 N. Wickham Rd.
Melbourne, FL 32935
bioactivenutritional.com - PACKAGE LABEL DISPLAY:
- INGREDIENTS AND APPEARANCE
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 liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43857-0002 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT 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 ZANTHOXYLUM AMERICANUM BARK (UNII: A4KL1HMZ7T) (ZANTHOXYLUM AMERICANUM BARK - UNII:A4KL1HMZ7T) ZANTHOXYLUM AMERICANUM BARK 3 [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 CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN) CHELIDONIUM MAJUS 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 PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN) PHOSPHORIC ACID 12 [hp_X] in 1 mL ASPARTAME (UNII: Z0H242BBR1) (ASPARTAME - UNII:Z0H242BBR1) ASPARTAME 30 [hp_X] in 1 mL BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 30 [hp_X] in 1 mL FORMALDEHYDE (UNII: 1HG84L3525) (FORMALDEHYDE - UNII:1HG84L3525) FORMALDEHYDE 30 [hp_X] in 1 mL METHYLENE CHLORIDE (UNII: 588X2YUY0A) (METHYLENE CHLORIDE - UNII:588X2YUY0A) METHYLENE CHLORIDE 30 [hp_X] in 1 mL METHYLPARABEN (UNII: A2I8C7HI9T) (METHYLPARABEN - UNII:A2I8C7HI9T) METHYLPARABEN 30 [hp_X] in 1 mL PROPYLPARABEN (UNII: Z8IX2SC1OH) (PROPYLPARABEN - UNII:Z8IX2SC1OH) PROPYLPARABEN 30 [hp_X] in 1 mL SODIUM BENZOATE (UNII: OJ245FE5EU) (BENZOIC ACID - UNII:8SKN0B0MIM) SODIUM BENZOATE 30 [hp_X] in 1 mL SODIUM CITRATE (UNII: 1Q73Q2JULR) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) SODIUM CITRATE 30 [hp_X] in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 30 [hp_X] in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 30 [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:43857-0002-1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 02/08/2017 01/11/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/10/2013 01/11/2023 Labeler - BioActive Nutritional, Inc. (624980496) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(43857-0002) , api manufacture(43857-0002) , label(43857-0002) , pack(43857-0002)