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

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Drug Facts:

ACTIVE INGREDIENTS:

Alfalfa 1C, Aralia Quinquefolia 2C, Avena Sativa 1C, Beta Vulgaris 2C, Calendula Officinalis 2C, Chelidonium Majus 1C, Echinacea (Angustifolia) 2C, Natrum Muriaticum 2C, Oxalis Acetosella 2C, Paloondo 2C, Phytolacca Decandra 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, Germanium Metallicum 8C.

INDICATIONS:

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:

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 
alfalfa, aralia quinquefolia, avena sativa, beta vulgaris, calendula officinalis, chelidonium majus, echinacea (angustifolia), natrum muriaticum, oxalis acetosella, paloondo, phytolacca decandra, trifolium pratense, urtica dioica, viscum album, cobalt acetate, cobalt gluconate, copper gluconate, cuprum aceticum, glutathione, magnesium gluconicum dihydricum, ganoderma lucidum, ubidecarenonum, argentum metallicum, germanium metallicum liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0490
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALFALFA (UNII: DJO934BRBD) (ALFALFA - UNII:DJO934BRBD) ALFALFA2 [hp_C]  in 1 mL
AMERICAN GINSENG (UNII: 8W75VCV53Q) (AMERICAN GINSENG - UNII:8W75VCV53Q) AMERICAN GINSENG2 [hp_C]  in 1 mL
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP2 [hp_C]  in 1 mL
BETA VULGARIS (UNII: 4G174V5051) (BETA VULGARIS - UNII:4G174V5051) BETA VULGARIS2 [hp_C]  in 1 mL
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP2 [hp_C]  in 1 mL
CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN) CHELIDONIUM MAJUS2 [hp_C]  in 1 mL
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA2 [hp_C]  in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE2 [hp_C]  in 1 mL
OXALIS ACETOSELLA LEAF (UNII: U1W3U02EW0) (OXALIS ACETOSELLA LEAF - UNII:U1W3U02EW0) OXALIS ACETOSELLA LEAF2 [hp_C]  in 1 mL
LARREA TRIDENTATA LEAF (UNII: PK0TXD049P) (LARREA TRIDENTATA LEAF - UNII:PK0TXD049P) LARREA TRIDENTATA LEAF2 [hp_C]  in 1 mL
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT2 [hp_C]  in 1 mL
TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828) (TRIFOLIUM PRATENSE FLOWER - UNII:4JS0838828) TRIFOLIUM PRATENSE FLOWER2 [hp_C]  in 1 mL
URTICA DIOICA (UNII: 710FLW4U46) (URTICA DIOICA - UNII:710FLW4U46) URTICA DIOICA2 [hp_C]  in 1 mL
VISCUM ALBUM FRUITING TOP (UNII: BK9092J5MP) (VISCUM ALBUM FRUITING TOP - UNII:BK9092J5MP) VISCUM ALBUM FRUITING TOP2 [hp_C]  in 1 mL
COBALTOUS ACETATE (UNII: 3XC4P44U7E) (COBALTOUS CATION - UNII:AI1MR454XG) COBALTOUS ACETATE3 [hp_C]  in 1 mL
COBALTOUS GLUCONATE (UNII: 26SK597UWV) (COBALTOUS CATION - UNII:AI1MR454XG) COBALTOUS GLUCONATE3 [hp_C]  in 1 mL
COPPER GLUCONATE (UNII: RV823G6G67) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION3 [hp_C]  in 1 mL
CUPRIC ACETATE (UNII: 39M11XPH03) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC ACETATE3 [hp_C]  in 1 mL
GLUTATHIONE (UNII: GAN16C9B8O) (GLUTATHIONE - UNII:GAN16C9B8O) GLUTATHIONE3 [hp_C]  in 1 mL
MAGNESIUM GLUCONATE (UNII: T42NAD2KHC) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM GLUCONATE3 [hp_C]  in 1 mL
REISHI (UNII: TKD8LH0X2Z) (REISHI - UNII:TKD8LH0X2Z) REISHI5 [hp_C]  in 1 mL
UBIDECARENONE (UNII: EJ27X76M46) (UBIDECARENONE - UNII:EJ27X76M46) UBIDECARENONE5 [hp_C]  in 1 mL
SILVER (UNII: 3M4G523W1G) (SILVER - UNII:3M4G523W1G) SILVER8 [hp_C]  in 1 mL
GERMANIUM (UNII: 00072J7XWS) (GERMANIUM - UNII:00072J7XWS) GERMANIUM8 [hp_C]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43857-0490-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product09/10/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic09/10/2018
Labeler - BioActive Nutritional, Inc. (624980496)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(43857-0490) , api manufacture(43857-0490) , label(43857-0490) , pack(43857-0490)

Revised: 9/2018
Document Id: abb9e2e2-ae38-48f8-8e97-3e9e23caabc4
Set id: 3162459e-681f-4a8a-82f1-2dcf8f5c14dd
Version: 2
Effective Time: 20180911
 
BioActive Nutritional, Inc.