APIZELEN- germanium metallicum, alfalfa, aralia quinquefolia, avena sativa, beta vulgaris, calendula officinalis, chelidonium majus, echinacea (angustifolia), natrum muriaticum, paloondo, phytolacca decandra, taraxacum officinale, trifolium pratense, urtica dioica, viscum album, cobalt acetate, cobalt gluconate, copper gluconate, cuprum aceticum, glutathione, magnesium gluconicum dihydricum, ganoderma lucidum, ubidecarenonum, argentum metallicum 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:

Germanium Metallicum 15X, Alfalfa 2C, Aralia Quinquefolia 2C, Avena Sativa 2C, Beta Vulgaris 2C, Calendula Officinalis 2C, Chelidonium Majus 2C, Echinacea (Angustifolia) 2C, Natrum Muriaticum 2C, Paloondo 2C, Phytolacca Decandra 2C, Taraxacum Officinale 2C, Trifolium Pratense 2C, Urtica Dioica 2C, Viscum Album 2C, Cobalt Acetate 3C, Cobalt Gluconate 3C, Copper Gluconate 3C, Cuprum Aceticum 3C, Glutathione 3C, Magnesium Gluconicum Dihydricum 3C, Ganoderma Lucidum 5C, Ubidecarenonum 5C, Argentum Metallicum 8C.

PURPOSE:

For temporary relief of fatigue, indigestion, and flatulent colic.

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:

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 fatigue, indigestion, and flatulent colic.

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

APIZELEN

HOMEOPATHIC

1 FL OZ (30 ml)

APIZELEN

APIZELEN
germanium metallicum, alfalfa, aralia quinquefolia, avena sativa, beta vulgaris, calendula officinalis, chelidonium majus, echinacea (angustifolia), natrum muriaticum, paloondo, phytolacca decandra, taraxacum officinale, trifolium pratense, urtica dioica, viscum album, cobalt acetate, cobalt gluconate, copper gluconate, cuprum aceticum, glutathione, magnesium gluconicum dihydricum, ganoderma lucidum, ubidecarenonum, argentum metallicum liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43857-0640
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GERMANIUM (UNII: 00072J7XWS) (GERMANIUM - UNII:00072J7XWS)	GERMANIUM	15 [hp_X] in 1 mL
MEDICAGO SATIVA WHOLE (UNII: DJO934BRBD) (ALFALFA - UNII:DJO934BRBD)	MEDICAGO SATIVA WHOLE	2 [hp_C] in 1 mL
AMERICAN GINSENG (UNII: 8W75VCV53Q) (AMERICAN GINSENG - UNII:8W75VCV53Q)	AMERICAN GINSENG	2 [hp_C] in 1 mL
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F)	AVENA SATIVA FLOWERING TOP	2 [hp_C] in 1 mL
BETA VULGARIS WHOLE (UNII: 4G174V5051) (BETA VULGARIS - UNII:4G174V5051)	BETA VULGARIS WHOLE	2 [hp_C] in 1 mL
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ)	CALENDULA OFFICINALIS FLOWERING TOP	2 [hp_C] in 1 mL
CHELIDONIUM MAJUS WHOLE (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN)	CHELIDONIUM MAJUS WHOLE	2 [hp_C] in 1 mL
ECHINACEA ANGUSTIFOLIA WHOLE (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8)	ECHINACEA ANGUSTIFOLIA WHOLE	2 [hp_C] in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	2 [hp_C] in 1 mL
LARREA TRIDENTATA LEAF (UNII: PK0TXD049P) (LARREA TRIDENTATA LEAF - UNII:PK0TXD049P)	LARREA TRIDENTATA LEAF	2 [hp_C] in 1 mL
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG)	PHYTOLACCA AMERICANA ROOT	2 [hp_C] in 1 mL
TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375)	TARAXACUM OFFICINALE	2 [hp_C] in 1 mL
TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828) (TRIFOLIUM PRATENSE FLOWER - UNII:4JS0838828)	TRIFOLIUM PRATENSE FLOWER	2 [hp_C] in 1 mL
URTICA DIOICA WHOLE (UNII: 710FLW4U46) (URTICA DIOICA - UNII:710FLW4U46)	URTICA DIOICA WHOLE	2 [hp_C] in 1 mL
VISCUM ALBUM FRUITING TOP (UNII: BK9092J5MP) (VISCUM ALBUM FRUITING TOP - UNII:BK9092J5MP)	VISCUM ALBUM FRUITING TOP	2 [hp_C] in 1 mL
COBALTOUS ACETATE (UNII: 3XC4P44U7E) (COBALTOUS CATION - UNII:AI1MR454XG)	COBALTOUS ACETATE	3 [hp_C] in 1 mL
COBALTOUS GLUCONATE (UNII: 26SK597UWV) (COBALTOUS CATION - UNII:AI1MR454XG)	COBALTOUS GLUCONATE	3 [hp_C] in 1 mL
COPPER GLUCONATE (UNII: RV823G6G67) (CUPRIC CATION - UNII:8CBV67279L)	CUPRIC CATION	3 [hp_C] in 1 mL
CUPRIC ACETATE (UNII: 39M11XPH03) (CUPRIC CATION - UNII:8CBV67279L)	CUPRIC ACETATE	3 [hp_C] in 1 mL
GLUTATHIONE (UNII: GAN16C9B8O) (GLUTATHIONE - UNII:GAN16C9B8O)	GLUTATHIONE	3 [hp_C] in 1 mL
MAGNESIUM GLUCONATE (UNII: T42NAD2KHC) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM GLUCONATE	3 [hp_C] in 1 mL
REISHI (UNII: TKD8LH0X2Z) (REISHI - UNII:TKD8LH0X2Z)	REISHI	5 [hp_C] in 1 mL
UBIDECARENONE (UNII: EJ27X76M46) (UBIDECARENONE - UNII:EJ27X76M46)	UBIDECARENONE	5 [hp_C] in 1 mL
SILVER (UNII: 3M4G523W1G) (SILVER - UNII:3M4G523W1G)	SILVER	8 [hp_C] 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:43857-0640-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	05/15/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		05/15/2024

Labeler - BioActive Nutritional, Inc. (624980496)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(43857-0640) , api manufacture(43857-0640) , label(43857-0640) , pack(43857-0640)