Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

HEPATATOX- triticum aestivum, chelidonium majus, taraxacum officinale, glutathione, hepar suis, thyroidinum (suis), lycopodium clavatum, nux vomica, phosphoricum acidum, aceticum acidum, adrenocorticotrophin, benzoicum acidum, benzyl alcohol, boricum acidum, chlorinum, cortisone aceticum, eugenol, folliculinum, isopropyl palmitate, lacticum acidum, petroleum jelly, phenylbutazone, plumbum metallicum, potassium sorbate, resorcinol, salicylieum acidum, sorbitol, steary alcohol, xylitol, 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.

----------

Drug Facts

ACTIVE INGREDIENTS

Triticum Aestivum 1X, Chelidonium Majus 3X, Taraxacum Officinale 3X, Glutathione 6X, Hepar Suis 8X, Thyroidinum (Suis) 8X, Lycopodium Clavatum 12X, Nux Vomica 12X, Phosphoricum Acidum 12X, Aceticum acidum 30X, 60X, 200X, Adrenocorticotrophin 30X, 60X, 200X, Benzoicum acidum 30X, 60X, 200X, Benzyl alcohol 30X, 60X, 200X, Boricum acidum 30X, 60X, 200X, Chlorinum 30X, 60X, 200X, Cortisone aceticum 30X, 60X, 200X, Eugenol 30X, 60X, 200X, Folliculinum 30X, 60X, 200X, Isopropyl palmitate 30X, 60X, 200X, Lacticum acidum 30X, 60X, 200X, Petroleum jelly 30X, 60X, 200X, Phenylbutazone 30X, 60X, 200X, Plumbum metallicum 30X, 60X, 200X, Potassium sorbate 30X, 60X, 200X, Resorcinol 30X, 60X, 200X, Salicylicum acidum 30X, 60X, 200X, Sorbitol 30X, 60X, 200X, Stearyl alcohol 30X, 60X, 200X, Xylitol 30X, 60X, 200X,

INDICATIONS

For temporary relief of dyspepsia, flatulence, exhaustion, and nausea as a consequence of constipation.

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

In case of overdose, get medical help or contact a Poison Control Center right away.

INDICATIONS AND USAGE

For temporary relief of dyspepsia, flatulence, exhaustion, and nausea as a consequence of constipation.

QUESTIONS

Distributed by:

BIOACTIVE NUTRITIONAL

Melbourne, FL 32935

For Nutritional Information write:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

BioActive Homeopathic

HEPATATOX

1 FL OZ (30 ml)

Hepatatox

HEPATATOX 
triticum aestivum, chelidonium majus, taraxacum officinale, glutathione, hepar suis, thyroidinum (suis), lycopodium clavatum, nux vomica, phosphoricum acidum, aceticum acidum, adrenocorticotrophin, benzoicum acidum, benzyl alcohol, boricum acidum, chlorinum, cortisone aceticum, eugenol, folliculinum, isopropyl palmitate, lacticum acidum, petroleum jelly, phenylbutazone, plumbum metallicum, potassium sorbate, resorcinol, salicylieum acidum, sorbitol, steary alcohol, xylitol, liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 43857-0013
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRITICUM AESTIVUM WHOLE (UNII: 3C3Y389JBU) (TRITICUM AESTIVUM WHOLE - UNII:3C3Y389JBU) TRITICUM AESTIVUM WHOLE1 [hp_X]  in 1 mL
CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN) CHELIDONIUM MAJUS3 [hp_X]  in 1 mL
TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375) TARAXACUM OFFICINALE3 [hp_X]  in 1 mL
GLUTATHIONE (UNII: GAN16C9B8O) (GLUTATHIONE - UNII:GAN16C9B8O) GLUTATHIONE6 [hp_X]  in 1 mL
PORK LIVER (UNII: 6EC706HI7F) (PORK LIVER - UNII:6EC706HI7F) PORK LIVER8 [hp_X]  in 1 mL
SUS SCROFA THYROID (UNII: 6RV024OAUQ) (SUS SCROFA THYROID - UNII:6RV024OAUQ) SUS SCROFA THYROID8 [hp_X]  in 1 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE12 [hp_X]  in 1 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED12 [hp_X]  in 1 mL
PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN) PHOSPHORIC ACID12 [hp_X]  in 1 mL
ACETIC ACID (UNII: Q40Q9N063P) (ACETIC ACID - UNII:Q40Q9N063P) ACETIC ACID30 [hp_X]  in 1 mL
CORTICOTROPIN (UNII: K0U68Q2TXA) (CORTICOTROPIN - UNII:K0U68Q2TXA) CORTICOTROPIN30 [hp_X]  in 1 mL
BENZOIC ACID (UNII: 8SKN0B0MIM) (BENZOIC ACID - UNII:8SKN0B0MIM) BENZOIC ACID30 [hp_X]  in 1 mL
BENZYL ALCOHOL (UNII: LKG8494WBH) (BENZYL ALCOHOL - UNII:LKG8494WBH) BENZYL ALCOHOL30 [hp_X]  in 1 mL
BORIC ACID (UNII: R57ZHV85D4) (BORIC ACID - UNII:R57ZHV85D4) BORIC ACID30 [hp_X]  in 1 mL
CHLORINE (UNII: 4R7X1O2820) (CHLORINE - UNII:4R7X1O2820) CHLORINE30 [hp_X]  in 1 mL
CORTISONE ACETATE (UNII: 883WKN7W8X) (CORTISONE - UNII:V27W9254FZ) CORTISONE ACETATE30 [hp_X]  in 1 mL
EUGENOL (UNII: 3T8H1794QW) (EUGENOL - UNII:3T8H1794QW) EUGENOL30 [hp_X]  in 1 mL
ESTRONE (UNII: 2DI9HA706A) (ESTRONE - UNII:2DI9HA706A) ESTRONE30 [hp_X]  in 1 mL
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) (ISOPROPYL PALMITATE - UNII:8CRQ2TH63M) ISOPROPYL PALMITATE30 [hp_X]  in 1 mL
LACTIC ACID, DL- (UNII: 3B8D35Y7S4) (LACTIC ACID, DL- - UNII:3B8D35Y7S4) LACTIC ACID, DL-30 [hp_X]  in 1 mL
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM30 [hp_X]  in 1 mL
PHENYLBUTAZONE (UNII: GN5P7K3T8S) (PHENYLBUTAZONE - UNII:GN5P7K3T8S) PHENYLBUTAZONE30 [hp_X]  in 1 mL
LEAD (UNII: 2P299V784P) (LEAD - UNII:2P299V784P) LEAD30 [hp_X]  in 1 mL
POTASSIUM SORBATE (UNII: 1VPU26JZZ4) (SORBIC ACID - UNII:X045WJ989B) POTASSIUM SORBATE30 [hp_X]  in 1 mL
RESORCINOL (UNII: YUL4LO94HK) (RESORCINOL - UNII:YUL4LO94HK) RESORCINOL30 [hp_X]  in 1 mL
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID30 [hp_X]  in 1 mL
SORBITOL (UNII: 506T60A25R) (SORBITOL - UNII:506T60A25R) SORBITOL30 [hp_X]  in 1 mL
STEARYL ALCOHOL (UNII: 2KR89I4H1Y) (STEARYL ALCOHOL - UNII:2KR89I4H1Y) STEARYL ALCOHOL30 [hp_X]  in 1 mL
XYLITOL (UNII: VCQ006KQ1E) (XYLITOL - UNII:VCQ006KQ1E) XYLITOL30 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 43857-0013-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic01/17/201305/19/2019
Labeler - BioActive Nutritional, Inc. (624980496)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(43857-0013) , api manufacture(43857-0013) , label(43857-0013) , pack(43857-0013)

Revised: 6/2015