HEPATAPLEX- boldo, carduus marianus, chelidonium majus, lappa major, petroselinum sativum, taraxacum officinale, glutathione, hepar suis, lycopodium clavatum, nux vomica, phosphorus 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:

Boldo 3X, Carduus Marianus 3X, Chelidonium Majus 3X, Lappa Major 3X, Petroselinum Sativum 3X, Taraxacum Officinale 3X, Glutathione 6X, Hepar Suis 6X, Lycopodium Clavatum 12X, Nux Vomica 12X, Phosphorus 12X.

INDICATIONS:

For temporary relief of abdominal bloating, & soreness, constipation alternating with diarrhea.

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.

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.

DIRECTIONS:

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

INDICATIONS:

For temporary relief of abdominal bloating, & soreness, constipation alternating with diarrhea.

INACTIVE INGREDIENTS:

Demineralized Water, 25% Ethanol

QUESTIONS:

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

PACKAGE LABEL DISPLAY:

BIOActive Nutritional

HEPATAPLEX

HOMEOPATHIC

1 FL OZ (30 ml)

Hepataplex

HEPATAPLEX
boldo, carduus marianus, chelidonium majus, lappa major, petroselinum sativum, taraxacum officinale, glutathione, hepar suis, lycopodium clavatum, nux vomica, phosphorus liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43857-0627
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PEUMUS BOLDUS LEAF (UNII: Q4EWM09M3O) (PEUMUS BOLDUS LEAF - UNII:Q4EWM09M3O)	PEUMUS BOLDUS LEAF	3 [hp_X] in 1 mL
MILK THISTLE (UNII: U946SH95EE) (MILK THISTLE - UNII:U946SH95EE)	MILK THISTLE	3 [hp_X] in 1 mL
CHELIDONIUM MAJUS WHOLE (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN)	CHELIDONIUM MAJUS WHOLE	3 [hp_X] in 1 mL
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3) (ARCTIUM LAPPA ROOT - UNII:597E9BI3Z3)	ARCTIUM LAPPA ROOT	3 [hp_X] in 1 mL
PETROSELINUM CRISPUM WHOLE (UNII: 1WZA4Y92EX) (PETROSELINUM CRISPUM - UNII:1WZA4Y92EX)	PETROSELINUM CRISPUM WHOLE	3 [hp_X] in 1 mL
TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375)	TARAXACUM OFFICINALE	3 [hp_X] in 1 mL
GLUTATHIONE (UNII: GAN16C9B8O) (GLUTATHIONE - UNII:GAN16C9B8O)	GLUTATHIONE	6 [hp_X] in 1 mL
PORK LIVER (UNII: 6EC706HI7F) (PORK LIVER - UNII:6EC706HI7F)	PORK LIVER	6 [hp_X] in 1 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	12 [hp_X] in 1 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	12 [hp_X] in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	12 [hp_X] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43857-0627-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	09/07/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		09/07/2022

Labeler - BioActive Nutritional, Inc. (624980496)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(43857-0627) , api manufacture(43857-0627) , label(43857-0627) , pack(43857-0627)