FDA.reportPublic FDA data

Hayfever Tonic

Manufacturer
BioActive Nutritional, Inc. | Apotheca Company
Effective date
2024-10-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:28:17

Label at a glance#

ProductHayfever Tonic
Active ingredientECHINACEA PURPUREA WHOLE, GOLDENSEAL, EUPATORIUM PERFOLIATUM FLOWERING TOP, VERBASCUM THAPSUS WHOLE, AILANTHUS ALTISSIMA FLOWERING TWIG, ONION, AMBROSIA ARTEMISIIFOLIA WHOLE, GOLD TRICHLORIDE, CAMPHOR (NATURAL), IPECAC, POTASSIUM DICHROMATE, SOLIDAGO VIRGAUREA FLOWERING TOP, POA PRATENSIS POLLEN, DACTYLIS GLOMERATA POLLEN, CYNODON DACTYLON POLLEN, SORGHUM HALEPENSE POLLEN, LOLIUM PERENNE POLLEN, ANTHOXANTHUM ODORATUM, PASPALUM NOTATUM POLLEN, PHLEUM PRATENSE POLLEN, ULMUS AMERICANA POLLEN, PLATANUS X ACERIFOLIA POLLEN, FRAXINUS EXCELSIOR POLLEN, FAGUS SYLVATICA POLLEN, SALIX X FRAGILIS POLLEN, ACER NEGUNDO POLLEN, ALNUS RUBRA POLLEN, JUNIPERUS VIRGINIANA POLLEN, ACER SACCHARUM POLLEN, CORYLUS AVELLANA POLLEN, POPULUS ALBA POLLEN, BETULA PENDULA POLLEN, QUERCUS ROBUR POLLEN, CARYA GLABRA POLLEN
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

Echinacea Purpurea MT, 3X, Hydrastis Canadensis 5X, Eupatorium Perfoliatum 6X, 12X, Verbascum Thapsus 8X, Ailanthus Glandulosus 12X, Allium Cepa 12X, Ambrosia Artemisiaefolia 12X, Aurum Muriaticum 12X, Camphora 12X, Ipecacuanha 12X, Kali Bichromicum 12X, Solidago Virgaurea 12X, Kentucky Bluegrass 16X, 24X, 30X, Orchard Grass16X, 24X, 30X, Bermuda Grass 16X, 24X, 30X, Johnson Grass 16X, 24X, 30X, Rye Grass 16X, 24X, 30X, Vernal Grass 16X, 24X, 30X, Bahia Grass 16X, 24X, 30X, Timothy Grass 16X, 24X, 30X, American Elm 16X, 24X, 30X, Plane (Sycamore) 16X, 24X, 30X, Ash 16X, 24X, 30X, Beech 16X, 24X, 30X, Willow 16X, 24X, 30X, Elder (Box Elder) 16X, 24X, 30X, Alder 16X, 24X, 30X, Cedar 16X, 24X, 30X, Maple 16X, 24X, 30X, Hazel 16X, 24X, 30X, Poplar 16X, 24X, 30X, Silver Birch 16X, 24X, 30X, Oak 16X, 24X, 30X, Hickory 16X, 24X, 30X.

INDICATIONS:

OTC - PURPOSE SECTION

For temporary relief of coryza, sneezing, water discharge. Stuffed up feeling of nose and head. Eyes red with much burning. Hoarseness and cough with soreness in the chest.

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 a 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 coryza, sneezing, water discharge. Stuffed up feeling of nose and head. Eyes red with much burning. Hoarseness and cough with soreness in the chest.

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
HAYFEVER TONIC

HOMEOPATHIC

2 FL OZ (60 ml)

Hayfever TonicHayfever Tonic

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43857-0611-12024-10-17C16284748780-1f386c649-b525-0266-e053-dadaa90a7c1aDRUG FACTS:
43857-0611-12023-01-30C16284748780-1f386c649-b525-0266-e053-dadaa90a7c1aDRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0611-1Hayfever Tonic60 mL in 1 BOTTLE, DROPPERLIQUID602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0611HAYFEVER TONIC (ECHINACEA PURPUREA, HYDRASTIS CANADENSIS, EUPATORIUM PERFOLIATUM, VERBASCUM THAPSUS, AILANTHUS GLANDULOSUS, ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, AURUM MURIATICUM, CAMPHORA, IPECACUANHA, KALI BICHROMICUM, SOLIDAGO VIRGAUREA, KENTUCKY BLUEGRASS, ORCHARD GRASS, BERMUDA GRASS, JOHNSON GRASS, RYE GRASS, VERNAL GRASS, BAHIA GRASS, TIMOTHY GRASS, AMERICAN ELM, PLANE (SYCAMORE), ASH, BEECH, WILLOW, ELDER (BOX ELDER), ALDER, CEDAR, MAPLE, HAZEL, POPLAR, SILVER BIRCH, OAK, HICKORY) LIQUID [BIOACTIVE NUTRITIONAL, INC.]2Current NDC, Legacy NDC, 1 package rows20241019_f4395bb7-c186-4e4f-a7cd-a7f3db46091a.zip

Products#

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

DailyMed product names page 1 of 2 · 45 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43857-061143857-0611-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 36 matching rows.

Name, UNII, Kind table
NameUNIIKind
ECHINACEA PURPUREA WHOLEQI7G114Y98ACTIB
GOLDENSEALZW3Z11D0JVACTIB
EUPATORIUM PERFOLIATUM FLOWERING TOP1W0775VX6EACTIB
VERBASCUM THAPSUS WHOLEC9TD27U172ACTIB
AILANTHUS ALTISSIMA FLOWERING TWIG8P29O5P7XUACTIB
ONION492225Q21HACTIB
AMBROSIA ARTEMISIIFOLIA WHOLE9W34L2CQ9AACTIB
GOLD TRICHLORIDE15443PR153ACTIB
CAMPHOR (NATURAL)N20HL7Q941ACTIB
IPECAC62I3C8233LACTIB
POTASSIUM DICHROMATET4423S18FMACTIB
SOLIDAGO VIRGAUREA FLOWERING TOP5405K23S50ACTIB
POA PRATENSIS POLLENSCB8J7LS3TACTIB
DACTYLIS GLOMERATA POLLEN83N78IDA7PACTIB
CYNODON DACTYLON POLLEN175F461W10ACTIB
SORGHUM HALEPENSE POLLEN577VA5B4HPACTIB
LOLIUM PERENNE POLLEN4T81LB52R0ACTIB
ANTHOXANTHUM ODORATUMYMW1K70E4QACTIB
PASPALUM NOTATUM POLLENV003SHB7VKACTIB
PHLEUM PRATENSE POLLEN65M88RW2EGACTIB
ULMUS AMERICANA POLLEN89BAT511BDACTIB
PLATANUS X ACERIFOLIA POLLEN77X11O684JACTIB
FRAXINUS EXCELSIOR POLLEN1824QUA0U3ACTIB
FAGUS SYLVATICA POLLEN63218N1ZBIACTIB
SALIX X FRAGILIS POLLENUQ7Z2EA3ZIACTIB
ACER NEGUNDO POLLENP6K070AR8VACTIB
ALNUS RUBRA POLLENZ0F2YK1B7HACTIB
JUNIPERUS VIRGINIANA POLLENPY0JA16R2GACTIB
ACER SACCHARUM POLLENV38QUQ7861ACTIB
CORYLUS AVELLANA POLLENCR2J49TL6LACTIB
POPULUS ALBA POLLENVU8C8SB23PACTIB
BETULA PENDULA POLLENZL5TV40C5YACTIB
QUERCUS ROBUR POLLEN4PNW66TTHRACTIB
CARYA GLABRA POLLENKPO1Z9N98AACTIB
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
Hayfever TonicECHINACEA PURPUREA, HYDRASTIS CANADENSIS, EUPATORIUM PERFOLIATUM, VERBASCUM THAPSUS, AILANTHUS GLANDULOSUS, ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, AURUM MURIATICUM, CAMPHORA, IPECACUANHA, KALI BICHROMICUM, SOLIDAGO VIRGAUREA, KENTUCKY BLUEGRASS, ORCHARD GRASS, BERMUDA GRASS, JOHNSON GRASS, RYE GRASS, VERNAL GRASS, BAHIA GRASS, TIMOTHY GRASS, AMERICAN ELM, PLANE (SYCAMORE), ASH, BEECH, WILLOW, ELDER (BOX ELDER), ALDER, CEDAR, MAPLE, HAZEL, POPLAR, SILVER BIRCH, OAK, HICKORYBioActive Nutritional, Inc.f4395bb7-c186-4e4f-a7cd-a7f3db46091a2024-10-17WarningsExact identifier
ndc (package): 43857-0611-1
ndc (product): 43857-0611
ndc11 (package): 43857061101
spl id: 4eff43ec-5032-4ce5-bcbb-ad01b10ea6c2
spl set id: f4395bb7-c186-4e4f-a7cd-a7f3db46091a

Reported adverse events (FAERS/openFDA)#

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