Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

APIZELEN- alfalfa, avena sativa, chelidonium majus, aralia quinquefolia, beta vulgaris, calendula officinalis, cuprum aceticum, echinacea, natrum muriaticum, oxalis acetosella, paloondo, phytolacca decandra, trifolium pratense, urtica dioica, viscum album, cobalt aceticum, cobalt gluconate, copper gluconate, glutathione, magnesium gluconate, ubiquinone, ling chi, 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, Avena sativa 1C, Chelidonium majus 1C, Aralia quinquefolia 2C, Beta vulgaris 2C, Calendula officinalis 2C, Cuprum aceticum 2C, Echinacea 2C, Natrum muriaticum 2C, Oxalis acetosella 2C, Paloondo 2C, Phytolacca decandra 2C, Trifolium pratense 2C, Urtica dioica 2C, Viscum album 2C, Cobalt aceticum 3C, Cobalt gluconate 3C, Copper gluconate 3C, Gluathione 3C, Magnesium gluconate 3C, Ubiquinone 3C, Ling chi 4C, Argentum metallicum 6C, Germanium metallicum 6C.

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.

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.

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

INDICATIONS:

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

QUESTIONS:

Distributed by:

BIOACTIVE NUTRITIONAL

Melbourne, FL 32935

For Nutritional Information write:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

PACKAGE LABEL DISPLAY

BioActive Homeopathic

APIZELEN

1 FL OZ (30 ml)

Apizelen

APIZELEN 
alfalfa, avena sativa, chelidonium majus, aralia quinquefolia, beta vulgaris, calendula officinalis, cuprum aceticum, echinacea, natrum muriaticum, oxalis acetosella, paloondo, phytolacca decandra, trifolium pratense, urtica dioica, viscum album, cobalt aceticum, cobalt gluconate, copper gluconate, glutathione, magnesium gluconate, ubiquinone, ling chi, argentum metallicum, germanium metallicum liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 43857-0094
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALFALFA (UNII: DJO934BRBD) (ALFALFA - UNII:DJO934BRBD) ALFALFA1 [hp_C]  in 1 mL
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP1 [hp_C]  in 1 mL
CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN) CHELIDONIUM MAJUS1 [hp_C]  in 1 mL
AMERICAN GINSENG (UNII: 8W75VCV53Q) (AMERICAN GINSENG - UNII:8W75VCV53Q) AMERICAN GINSENG2 [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
CUPRIC ACETATE (UNII: 39M11XPH03) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC ACETATE2 [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 TOP (UNII: PK0TXD049P) (LARREA TRIDENTATA TOP - UNII:PK0TXD049P) LARREA TRIDENTATA TOP2 [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
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
UBIDECARENONE (UNII: EJ27X76M46) (UBIDECARENONE - UNII:EJ27X76M46) UBIDECARENONE3 [hp_C]  in 1 mL
REISHI (UNII: TKD8LH0X2Z) (REISHI - UNII:TKD8LH0X2Z) REISHI4 [hp_C]  in 1 mL
SILVER (UNII: 3M4G523W1G) (SILVER - UNII:3M4G523W1G) SILVER6 [hp_C]  in 1 mL
GERMANIUM (UNII: 00072J7XWS) (GERMANIUM - UNII:00072J7XWS) GERMANIUM6 [hp_C]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 43857-0094-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product11/09/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic11/09/201207/08/2019
Labeler - BioActive Nutritional, Inc. (624980496)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(43857-0094) , api manufacture(43857-0094) , label(43857-0094) , pack(43857-0094)

Revised: 8/2016