FDA.reportPublic FDA data

Allergena

Manufacturer
Meditrend, Inc. DBA Progena Professional Formulations
Effective date
2020-06-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:25:15

Label at a glance#

ProductAllergena Seasonal Allergy Tabs
Active ingredientBAPTISIA TINCTORIA ROOT, GOLDENSEAL, MYRRH, NASTURTIUM OFFICINALE, PHYTOLACCA AMERICANA ROOT, FENUGREEK LEAF, ECHINACEA, UNSPECIFIED, ACACIA POLLEN, ALNUS RUBRA POLLEN, ALNUS INCANA SUBSP. RUGOSA POLLEN, FRAXINUS VELUTINA POLLEN, FRAXINUS PENNSYLVANICA POLLEN, FRAXINUS AMERICANA POLLEN, POPULUS TREMULOIDES POLLEN, MORELLA CERIFERA POLLEN, FAGUS GRANDIFOLIA POLLEN, BETULA PAPYRIFERA POLLEN, BETULA NIGRA POLLEN, BETULA LENTA POLLEN, ROBINIA PSEUDOACACIA POLLEN, ACER NEGUNDO POLLEN, JUNIPERUS ASHEI POLLEN, JUNIPERUS PINCHOTII POLLEN, JUNIPERUS VIRGINIANA POLLEN, POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN, POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN, CUPRESSUS ARIZONICA POLLEN, TAXODIUM DISTICHUM POLLEN, PHOENIX DACTYLIFERA POLLEN, ULMUS AMERICANA POLLEN, ULMUS CRASSIFOLIA POLLEN, ULMUS PUMILA POLLEN, ULMUS RUBRA POLLEN, EUCALYPTUS GLOBULUS POLLEN, PSEUDOTSUGA MENZIESII POLLEN, CELTIS OCCIDENTALIS POLLEN, CARYA GLABRA POLLEN, CARYA OVATA POLLEN, CARYA LACINIOSA POLLEN, CARYA ALBA POLLEN, LIGUSTRUM VULGARE POLLEN, ACER SACCHARUM POLLEN, ACER RUBRUM POLLEN, MORUS RUBRA POLLEN, QUERCUS VIRGINIANA POLLEN, QUERCUS RUBRA POLLEN, QUERCUS ALBA POLLEN, CARYA ILLINOINENSIS POLLEN, PINUS STROBUS POLLEN, POPULUS ALBA POLLEN, LIQUIDAMBAR STYRACIFLUA POLLEN, PLATANUS OCCIDENTALIS POLLEN, JUGLANS NIGRA POLLEN, SALIX NIGRA POLLEN, BACCHARIS HALIMIFOLIA POLLEN, AMARANTHUS PALMERI POLLEN, XANTHIUM STRUMARIUM POLLEN, RUMEX CRISPUS POLLEN, CHENOPODIUM ALBUM POLLEN, IVA ANNUA POLLEN, ARTEMISIA VULGARIS POLLEN, URTICA DIOICA POLLEN, AMARANTHUS RETROFLEXUS POLLEN, PLANTAGO LANCEOLATA POLLEN, AMBROSIA TRIFIDA POLLEN, AMBROSIA ARTEMISIIFOLIA POLLEN, PASPALUM NOTATUM POLLEN, CYNODON DACTYLON POLLEN, POA PRATENSIS POLLEN, FESTUCA PRATENSIS POLLEN, SORGHUM HALEPENSE POLLEN, LOLIUM PERENNE POLLEN, DACTYLIS GLOMERATA POLLEN, AGROSTIS GIGANTEA POLLEN
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: Antigens 6x, 12x, 30x:

*Seasonal Grasses, *Seasonal Trees, *Seasonal Weeds:  Herbal

Drainage Remedies 3x: Baptisia tinctoria HPUS, Hydrastis

canadensis HPUS, Phytolacca decandra HPUS, Trigonella foenum-

graecum; Echinacea 3X HPUS.

OTC - PURPOSE SECTION

Purpose: Relief from Sneezing, Runny Nose, Itchy Eyes and

Sinus Congestion.

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.

INDICATIONS & USAGE SECTION

Use: This product is a Homeopathic Dilution formulated to support the body's immunity for the temporary relief of allergies.

WARNINGS SECTION

Warnings:

  • Use only as directed.
  • Stop use and ask a doctor if symptoms worsen or do not improve after 5 days.
  • If pregnant or breastfeeding, consult a health professional before use.

DOSAGE & ADMINISTRATION SECTION

Directions: •Adults (12 and Older) Chew and dissolve 1

tablet three times daily.  • Children (7-12) Chew and 

dissolve 1 tablet three times daily.  • Children (2-7) Chew and

dissolve 1 tablet 2-3 times daily.  • Not recommended for

children under 2 years old.  • Consult a Physician for use in

children under 12 years of age.

OTHER SAFETY INFORMATION

Other Information: Do not use if TAMPER EVIDENT seal 

around neck of bottle is missing or broken.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Croscarmellose Sodium, Magnesium

Stearate, Microcrystalline Cellulose, Xylitol, Zemea.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Manufactured for PROGENA Professional Formulations

4820 Eubank Blvd. NE, ABQ, NM 87111,  www.progena.com

Image of LabelImage of Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62713-944-012020-06-18C16284748780-19d75b9d1-05f4-f424-e053-dadaa90a57ceAllergena Tabs
62713-944-012020-01-31C16284748780-19d75b9d1-05f4-f424-e053-dadaa90a57ceAllergena Tabs

Products#

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

DailyMed product names page 1 of 3 · 81 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62713-94462713-944-01

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 79 matching rows.

Name, UNII, Kind table
NameUNIIKind
CROSCARMELLOSE SODIUMM28OL1HH48IACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
XYLITOLVCQ006KQ1EIACT
PROPANEDIOL5965N8W85TIACT
BAPTISIA TINCTORIA ROOT5EF0HWI5WUACTIB
GOLDENSEALZW3Z11D0JVACTIB
MYRRHJC71GJ1F3LACTIB
NASTURTIUM OFFICINALEYH89GMV676ACTIB
PHYTOLACCA AMERICANA ROOT11E6VI8VEGACTIB
FENUGREEK LEAF487RI96K8ZACTIB
ECHINACEA, UNSPECIFIED4N9P6CC1DXACTIB
ACACIA POLLEN43DDR2YDYZACTIB
ALNUS RUBRA POLLENZ0F2YK1B7HACTIB
ALNUS INCANA SUBSP. RUGOSA POLLEN605T96G8Y5ACTIB
FRAXINUS VELUTINA POLLENLJT6I6Z8FDACTIB
FRAXINUS PENNSYLVANICA POLLEN2WZG2G15WXACTIB
FRAXINUS AMERICANA POLLENG684LX721QACTIB
POPULUS TREMULOIDES POLLEN928OC2TJDAACTIB
MORELLA CERIFERA POLLENLC8MEV9S89ACTIB
FAGUS GRANDIFOLIA POLLEN34X886W1H4ACTIB
BETULA PAPYRIFERA POLLEN3538FNV8AYACTIB
BETULA NIGRA POLLEN93963RFO1PACTIB
BETULA LENTA POLLENJQ5HI5004MACTIB
ROBINIA PSEUDOACACIA POLLEN8003NOJ82FACTIB
ACER NEGUNDO POLLENP6K070AR8VACTIB
JUNIPERUS ASHEI POLLEN544F8MEY0YACTIB
JUNIPERUS PINCHOTII POLLENS8A4X05W7JACTIB
JUNIPERUS VIRGINIANA POLLENPY0JA16R2GACTIB
POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN476DVV63WPACTIB
POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN5928LJ1441ACTIB
CUPRESSUS ARIZONICA POLLEN232DMH0XVFACTIB
TAXODIUM DISTICHUM POLLENO12H03B41RACTIB
PHOENIX DACTYLIFERA POLLEN2FV55IRB5BACTIB
ULMUS AMERICANA POLLEN89BAT511BDACTIB
ULMUS CRASSIFOLIA POLLENG82398SD3IACTIB
ULMUS PUMILA POLLEN030R993R8EACTIB
ULMUS RUBRA POLLENGHC6OHK0W0ACTIB
EUCALYPTUS GLOBULUS POLLEN7XW7TB10X9ACTIB
PSEUDOTSUGA MENZIESII POLLENZEI09763J3ACTIB

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
b6c1ac50-2acf-261e-e053-2995a90a0499f3da0e57-18a3-49ac-833c-b0b3fb3b49d72020-12-18WarningsExact identifier
spl set id: f3da0e57-18a3-49ac-833c-b0b3fb3b49d7

Reported adverse events (FAERS/openFDA)#

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