FDA.reportPublic FDA data

Pollens Early

Manufacturer
VIATREXX BIO INCORPORATED | Les Importations Herbasante Inc | 8046255 Canada Inc
Effective date
2018-01-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:14:29

Label at a glance#

ProductPollens Early
Active ingredientInterleukin-12 Human, Interferon Gamma-1a, Sus Scrofa Adrenal Gland, Bos Taurus Adrenal Gland, Apis Mellifera, Fumaria Officinalis Flowering Top, Gallic Acid, Calcium Sulfide, Histamine, Potassium Carbonate, Bos Taurus Lymph Vessel, Sus Scrofa Lymph Vessel, Manganese, Pinus Sylvestris Sprout, Black Pepper, Prunus Spinosa Flower Bud, Quercetin, Rutin, Salsolinol, Silicon Dioxide, Sus Scrofa Spleen, Sulfuric Acid, Sus Scrofa Thymus, Bos Taurus Thymus, Bos Taurus Spleen, Tilia Tomentosa Bud, Fraxinus Americana Pollen, Betula Nigra Pollen, Juglans Nigra Pollen, Ulmus Americana Pollen, Quercus Rubra Pollen, Fagus Grandifolia Pollen, Populus Deltoides Subsp. Deltoides Pollen, Carya Alba Pollen, Platanus Racemosa Pollen, Salix Repens Pollen, Acer Saccharum Pollen
Label structure10 sections

Indications and uses

For the temporary support of symptoms related to seasonal spring sensitivities

Storage and handling

Normal storage use. Do not use if tamper-evident seal is broken or removed.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

interleukin-12 human , interferon gamma-1a , sus scrofa adrenal gland , bos taurus adrenal gland , apis mellifera , fumaria officinalis flowering top , gallic acid , calcium sulfide , histamine , potassium carbonate , bos taurus lymph vessel , sus scrofa lymph vessel , manganese , pinus sylvestris sprout , black pepper , prunus spinosa flower bud , quercetin , rutin , salsolinol , silicon dioxide , sus scrofa spleen , sulfuric acid , sus scrofa thymus , bos taurus thymus , bos taurus spleen , tilia tomentosa bud , fraxinus americana pollen , betula nigra pollen , juglans nigra pollen , ulmus americana pollen , quercus rubra pollen , fagus grandifolia pollen , populus deltoides subsp. deltoides pollen , carya alba pollen , platanus racemosa pollen , salix repens pollen and acer saccharum pollen 

Purpose:

OTC - PURPOSE SECTION

Adrenal Gland                             6X, 200K    Adrenal support
Apis                                             30K             Anti-inflammation
Early season Allersode               6X, 200K    Immune support
Ethylicum                                    30K             Drainage
Fumaria Officinalis                      30K             Drainage
Gallic Acid                                   6X, 200K    Immune support
Hepar Sulphuris Calcareum        30K             Drainage
Histamine                                    6X, 200K    Ig support
IL- 12                                           10X, 200K  Immune support
Interferon gamma                        9X, 200K    Immune support
Kali Carbonicum                          30K             Drainage
Lymph nodes                               6X, 200K    Immune support
Manganese                                  12X             Regeneration
 Pinus Sylvestris                          30K             Regeneration
Piper Nigrum                                30K             Drainage
 Prunus Spinosa                          30K             Drainage
Quercetin                                     6X, 200K    Drainage
Rutin                                            6X, 200K    Drainage
Salsolinol                                     6X, 200K    Drainage
Silicea                                          6X, 200K    Drainage
Spleen                                         6X, 200K    Regeneration
Sulphuricum Acidum                   30K             Drainage
Thymus                                       6X, 200K    Immune support
Tilia Tomentosa                           30K             Neurological support 

Uses

INDICATIONS & USAGE SECTION

For the temporary support of symptoms related to seasonal spring sensitivities

Warnings

WARNINGS SECTION

Stop use and ask a health care practitioner if symptoms persist for more than five days or worsen. If pregnant or breastfeeding, ask a health care practitioner before use.

Dosage

DOSAGE & ADMINISTRATION SECTION

1-5 spray(s); 1-3 time(s) per day or as recommended by your health care practitioner.

 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all medicines out of reach of children.

Other Ingredients

INACTIVE INGREDIENT SECTION

20% Alcohol and 80% Water

Other Information

STORAGE AND HANDLING SECTION

Normal storage use.

Do not use if tamper-evident seal is broken or removed.

Questions

OTC - QUESTIONS SECTION

info@viatrexx.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ITEM: VPC0553

NDC 63776-440-15

Homeopathic remedy

Pollens Early

For the temporary support of symptoms related to seasonal spring sensitivities

Oral spray
50ml 1.7 oz

Viatrexx™ Bio Incorporated

Manufactured by Viatrexx
www.viatrexx.com
Newark, DE 19713

Pollens Early

50 ml
1.7 oz

Viatrexx™ Bio Incorporated

ITEM: VPC0553
NDC: 63776-440-15

INDICATIONS:
For the temporary support of symptoms related to seasonal spring sensitivities

DIRECTIONS:
1-5 spray(s); 1-3 time(s) per day or as recommended by your health care practitioner.

Mfg. for
Viatrexx Bio Incorporated.
www.viatrexx.com
Newark, DE 19713

pollens early
pollens early

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63776-440-112022-07-29C16284748780-1e4f33bdf-9e66-d8a0-e053-dadaa90a6e4ePollens Early
63776-440-142022-07-29C16284748780-1e4f33bdf-9e66-d8a0-e053-dadaa90a6e4ePollens Early
63776-440-152022-07-29C16284748780-1e4f33bdf-9e66-d8a0-e053-dadaa90a6e4ePollens Early
63776-440-162022-07-29C16284748780-1e4f33bdf-9e66-d8a0-e053-dadaa90a6e4ePollens Early
63776-440-172022-07-29C16284748780-1e4f33bdf-9e66-d8a0-e053-dadaa90a6e4ePollens Early
63776-440-182022-07-29C16284748780-1e4f33bdf-9e66-d8a0-e053-dadaa90a6e4ePollens Early
63776-440-192022-07-29C16284748780-1e4f33bdf-9e66-d8a0-e053-dadaa90a6e4ePollens Early

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63776-440-11Pollens Early0.5 mL in 1 AMPULESPRAY0.51
63776-440-14Pollens Early30 mL in 1 BOTTLESPRAY301
63776-440-15Pollens Early50 mL in 1 BOTTLESPRAY501
63776-440-16Pollens Early100 mL in 1 BOTTLESPRAY1001
63776-440-17Pollens Early250 mL in 1 BOTTLESPRAY2501
63776-440-18Pollens Early500 mL in 1 BOTTLESPRAY5001
63776-440-19Pollens Early1000 mL in 1 BOTTLESPRAY10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63776-440POLLENS EARLY (ADRENAL, APIS, EARLY SEASON ALLERSODE (ASH, BEECH, BIRCH, COTTONWOOD, ELM, HICKORY, MAPLE, RED OAK, SYCAMORE, WALNUT, WILLOW), ETHANOL, FUMARIA, GALLIC ACID, HEPAR SULPH CALC, HISTAMINE, INTERLEUKIN-12 HUMAN, INTERFERON GAMMA-1A, KALI CARB, LYMPH NODE, MANGANESE, PINUS SYLVESTRE, PIPER NIGRUM, PRUNUS SPINOSA, QUERCETIN, RUTIN, SALSOLINOL, SILICEA, SPLEEN, SULPHRICUM ACIDUM, THYMUS, TILIA TOMENTOSA) SPRAY [VIATREXX BIO INCORPORATED]1Legacy NDC, 7 package rows20210328_09ad465d-437e-4449-bcca-31b1527a568d.zip

Products#

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

DailyMed product names page 1 of 2 · 42 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63776-44063776-440-11, 63776-440-15, 63776-440-16, 63776-440-17, 63776-440-18, 63776-440-19, 63776-440-14

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 39 matching rows.

Name, UNII, Kind table
NameUNIIKind
Interleukin-12 Human7B590791ERACTIB
Interferon Gamma-1aVC9M78242PACTIB
Alcohol3K9958V90MIACT
Water059QF0KO0RIACT
Sus Scrofa Adrenal Gland398IYQ16YVACTIB
Bos Taurus Adrenal GlandM2776SWB29ACTIB
Apis Mellifera7S82P3R43ZACTIB
Fumaria Officinalis Flowering TopVH659J61ZLACTIB
Gallic Acid632XD903SPACTIB
Calcium Sulfide1MBW07J51QACTIB
Histamine820484N8I3ACTIB
Potassium CarbonateBQN1B9B9HAACTIB
Bos Taurus Lymph Vessel85I1Z426OVACTIB
Sus Scrofa Lymph VesselSFL7R07748ACTIB
Manganese42Z2K6ZL8PACTIB
Pinus Sylvestris Sprout5M5LA1PB91ACTIB
Black PepperKM66971LVFACTIB
Prunus Spinosa Flower Bud53Y84VPS2WACTIB
Quercetin9IKM0I5T1EACTIB
Rutin5G06TVY3R7ACTIB
Salsolinol9ILS801M65ACTIB
Silicon DioxideETJ7Z6XBU4ACTIB
Sus Scrofa Spleen92AMN5J79YACTIB
Sulfuric AcidO40UQP6WCFACTIB
Sus Scrofa Thymus7B69B0BD62ACTIB
Bos Taurus Thymus8XEJ88V2T8ACTIB
Bos Taurus Spleen190Q9MB3U3ACTIB
Tilia Tomentosa BudZ092RFX1IWACTIB
Fraxinus Americana PollenG684LX721QACTIB
Betula Nigra Pollen93963RFO1PACTIB
Juglans Nigra Pollen1BV28146ZRACTIB
Ulmus Americana Pollen89BAT511BDACTIB
Quercus Rubra PollenSVW19ET93CACTIB
Fagus Grandifolia Pollen34X886W1H4ACTIB
Populus Deltoides Subsp. Deltoides Pollen476DVV63WPACTIB
Carya Alba PollenG2A764T54BACTIB
Platanus Racemosa PollenBWC8DYU8OSACTIB
Salix Repens PollenI526G6336TACTIB
Acer Saccharum PollenV38QUQ7861ACTIB

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
40d8aded-da99-4754-aca4-6a7d4cfb585909ad465d-437e-4449-bcca-31b1527a568d2018-01-11WarningsExact identifier
spl id: 40d8aded-da99-4754-aca4-6a7d4cfb5859
spl set id: 09ad465d-437e-4449-bcca-31b1527a568d

Reported adverse events (FAERS/openFDA)#

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