FDA.reportPublic FDA data

Apizelen

Manufacturer
BioActive Nutritional, Inc. | Apotheca Company
Effective date
2024-05-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:03:17

Label at a glance#

ProductApizelen
Active ingredientMEDICAGO SATIVA WHOLE, AVENA SATIVA FLOWERING TOP, CHELIDONIUM MAJUS WHOLE, AMERICAN GINSENG, BETA VULGARIS WHOLE, CALENDULA OFFICINALIS FLOWERING TOP, ECHINACEA ANGUSTIFOLIA WHOLE, SODIUM CHLORIDE, OXALIS ACETOSELLA LEAF, LARREA TRIDENTATA LEAF, PHYTOLACCA AMERICANA ROOT, TRIFOLIUM PRATENSE FLOWER, URTICA DIOICA WHOLE, VISCUM ALBUM FRUITING TOP, COBALTOUS ACETATE, COBALTOUS GLUCONATE, COPPER GLUCONATE, CUPRIC ACETATE, GLUTATHIONE, MAGNESIUM GLUCONATE, REISHI, UBIDECARENONE, SILVER, GERMANIUM
Label structure9 sections

Dosage and administration

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

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Alfalfa 1C, Avena Sativa 1C, Chelidonium Majus 1C, Aralia Quinquefolia 2C, Beta Vulgaris 2C, Calendula Officinalis 2C, 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:

OTC - PURPOSE SECTION

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

WARNINGS:

WARNINGS SECTION

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:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

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

INDICATIONS:

INDICATIONS & USAGE SECTION

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

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized Water, 25% Ethanol

QUESTIONS:

OTC - QUESTIONS SECTION

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

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BIOActive Nutritional

APIZELEN

HOMEOPATHIC

1 FL OZ (30 ml)

ApizelenApizelen

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 37 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43857-040843857-0408-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
MEDICAGO SATIVA WHOLEDJO934BRBDACTIB
AVENA SATIVA FLOWERING TOPMA9CQJ3F7FACTIB
CHELIDONIUM MAJUS WHOLE7E889U5RNNACTIB
AMERICAN GINSENG8W75VCV53QACTIB
BETA VULGARIS WHOLE4G174V5051ACTIB
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQACTIB
ECHINACEA ANGUSTIFOLIA WHOLEVB06AV5US8ACTIB
SODIUM CHLORIDE451W47IQ8XACTIB
OXALIS ACETOSELLA LEAFU1W3U02EW0ACTIB
LARREA TRIDENTATA LEAFPK0TXD049PACTIB
PHYTOLACCA AMERICANA ROOT11E6VI8VEGACTIB
TRIFOLIUM PRATENSE FLOWER4JS0838828ACTIB
URTICA DIOICA WHOLE710FLW4U46ACTIB
VISCUM ALBUM FRUITING TOPBK9092J5MPACTIB
COBALTOUS ACETATE3XC4P44U7EACTIB
COBALTOUS GLUCONATE26SK597UWVACTIB
COPPER GLUCONATERV823G6G67ACTIM
CUPRIC ACETATE39M11XPH03ACTIB
GLUTATHIONEGAN16C9B8OACTIB
MAGNESIUM GLUCONATET42NAD2KHCACTIB
REISHITKD8LH0X2ZACTIB
UBIDECARENONEEJ27X76M46ACTIB
SILVER3M4G523W1GACTIB
GERMANIUM00072J7XWSACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d465c20d-5d92-414c-ba36-10127e06b703eb4e343b-dbc8-43d3-93aa-042869de090c2024-05-08WarningsExact identifier
spl id: d465c20d-5d92-414c-ba36-10127e06b703
spl set id: eb4e343b-dbc8-43d3-93aa-042869de090c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.