FDA.reportPublic FDA data

Allergena

Manufacturer
Meditrend, Inc. DBA Progena Professional Formulations
Effective date
2020-12-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:04:00

Label at a glance#

ProductAllergena Zone 8
Active ingredientECHINACEA, UNSPECIFIED, BAPTISIA TINCTORIA ROOT, GOLDENSEAL, MYRRH, NASTURTIUM OFFICINALE, PHYTOLACCA AMERICANA ROOT, FENUGREEK LEAF, ALNUS RUBRA POLLEN, FRAXINUS AMERICANA POLLEN, POPULUS TREMULOIDES POLLEN, FAGUS GRANDIFOLIA POLLEN, BETULA NIGRA POLLEN, JUNIPERUS ASHEI POLLEN, JUNIPERUS VIRGINIANA POLLEN, POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN, ULMUS AMERICANA POLLEN, ULMUS PUMILA POLLEN, PSEUDOTSUGA MENZIESII POLLEN, CELTIS OCCIDENTALIS POLLEN, CARYA ALBA POLLEN, JUNIPERUS SCOPULORUM POLLEN, ACER SACCHARUM POLLEN, ACER RUBRUM POLLEN, MORUS ALBA POLLEN, PINUS STROBUS POLLEN, POPULUS NIGRA POLLEN, POPULUS ALBA POLLEN, LIGUSTRUM VULGARE POLLEN, PICEA PUNGENS POLLEN, LIQUIDAMBAR STYRACIFLUA POLLEN, PLATANUS OCCIDENTALIS POLLEN, AILANTHUS ALTISSIMA POLLEN, JUGLANS REGIA POLLEN, SALIX NIGRA POLLEN, XANTHIUM STRUMARIUM POLLEN, BASSIA SCOPARIA POLLEN, SOLIDAGO CANADENSIS POLLEN, SARCOBATUS VERMICULATUS POLLEN, CHENOPODIUM ALBUM POLLEN, CYCLACHAENA XANTHIFOLIA POLLEN, IVA ANNUA POLLEN, ARTEMISIA VULGARIS POLLEN, URTICA DIOICA POLLEN, AMARANTHUS RETROFLEXUS POLLEN, AMARANTHUS SPINOSUS POLLEN, PLANTAGO LANCEOLATA POLLEN, AMBROSIA ACANTHICARPA POLLEN, ARTEMISIA TRIDENTATA POLLEN, ARTEMISIA LUDOVICIANA POLLEN, ATRIPLEX CONFERTIFOLIA POLLEN, RUMEX ACETOSELLA POLLEN, SALSOLA TRAGUS POLLEN, AMARANTHUS TUBERCULATUS POLLEN, ATRIPLEX CANESCENS POLLEN, ARTEMISIA ABSINTHIUM POLLEN, BROMUS INERMIS POLLEN, PHALARIS ARUNDINACEA POLLEN, ZEA MAYS POLLEN, LOLIUM MULTIFLORUM POLLEN, SORGHUM HALEPENSE POLLEN, POA PRATENSIS POLLEN, FESTUCA PRATENSIS POLLEN, AVENA SATIVA POLLEN, DACTYLIS GLOMERATA POLLEN, AGROSTIS GIGANTEA POLLEN, LOLIUM PERENNE POLLEN, PHLEUM PRATENSE POLLEN, ANTHOXANTHUM ODORATUM POLLEN, TRITICUM AESTIVUM POLLEN, PASCOPYRUM SMITHII POLLEN
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: Antigens 6x, 12x, 30x: **Zone 8 Grasses, **Zone 8 Trees, **Zone 8 Weeds; Herbal  Drainage Remedies 3x: Baptisia tinctoria HPUS, Hydrastis canadensis HPUS, Myrrha HPUS, Nasturtium aquaticum HPUS, Phytolacca decandra HPUS, Trigonella foenum-graecum; Echinacea 3X HPUS.

OTC - PURPOSE SECTION

Purpose:Relief from Sneezing, Runny Nose, Itchy Eyes and Sinus Congestion.*

INDICATIONS & USAGE SECTION

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

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.

WARNINGS SECTION

Warnings:

  • Use Only as directed.
  • Stop use and ask a doctor if symptoms worsen or do not improve after 5 days.

DOSAGE & ADMINISTRATION SECTION

Directions:•Shake Well Before Use. • Adults (12 and Older) 10-15 drops under the tongue three times daily. • Children (2-12) 6-10 drops under the tongue three times daily. • Infants (0-2) 3-6 drops under the toung three times daily or as directed by your health care professional.

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:USP Purified Water and Vegetable Glycerin.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

*www.allergena.com/drugdisclaimer

**Standard antigen mix used in this product is cross-reactive with Zone 8 Tree, Weed, and Grass allergens. For a complete list of allergens visit www.allergena.com

Manufactured for Progena Professional Formulations
4820 Eubank Blvd. NE, ABQ, NM 87111, www.progena.com

image of label
image of label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62713-823-012025-02-01C16284748780-12cef2736-8413-d83d-e063-dadaa90ab31fAllergena Trees, Weeds and Grasses - Zone 8 Kids

Products#

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

DailyMed product names page 1 of 2 · 74 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62713-82362713-823-01

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 72 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ECHINACEA, UNSPECIFIED4N9P6CC1DXACTIB
BAPTISIA TINCTORIA ROOT5EF0HWI5WUACTIB
GOLDENSEALZW3Z11D0JVACTIB
MYRRHJC71GJ1F3LACTIB
NASTURTIUM OFFICINALEYH89GMV676ACTIB
PHYTOLACCA AMERICANA ROOT11E6VI8VEGACTIB
FENUGREEK LEAF487RI96K8ZACTIB
ALNUS RUBRA POLLENZ0F2YK1B7HACTIB
FRAXINUS AMERICANA POLLENG684LX721QACTIB
POPULUS TREMULOIDES POLLEN928OC2TJDAACTIB
FAGUS GRANDIFOLIA POLLEN34X886W1H4ACTIB
BETULA NIGRA POLLEN93963RFO1PACTIB
JUNIPERUS ASHEI POLLEN544F8MEY0YACTIB
JUNIPERUS VIRGINIANA POLLENPY0JA16R2GACTIB
POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN5928LJ1441ACTIB
ULMUS AMERICANA POLLEN89BAT511BDACTIB
ULMUS PUMILA POLLEN030R993R8EACTIB
PSEUDOTSUGA MENZIESII POLLENZEI09763J3ACTIB
CELTIS OCCIDENTALIS POLLEN68R9X9Y96XACTIB
CARYA ALBA POLLENG2A764T54BACTIB
JUNIPERUS SCOPULORUM POLLEN0G82TT8ZFYACTIB
ACER SACCHARUM POLLENV38QUQ7861ACTIB
ACER RUBRUM POLLEN700NK45C76ACTIB
MORUS ALBA POLLEN3I9T68187HACTIB
PINUS STROBUS POLLENTX1ER5UV3TACTIB
POPULUS NIGRA POLLEN0MGE63QPFJACTIB
POPULUS ALBA POLLENVU8C8SB23PACTIB
LIGUSTRUM VULGARE POLLENY3FRX92Z0EACTIB
PICEA PUNGENS POLLENR9JBC6687XACTIB
LIQUIDAMBAR STYRACIFLUA POLLEN5Q246DS5BSACTIB
PLATANUS OCCIDENTALIS POLLENE03U1K03LKACTIB
AILANTHUS ALTISSIMA POLLEN2A64U81OQ3ACTIB
JUGLANS REGIA POLLENARW43087I1ACTIB
SALIX NIGRA POLLEN6M2JIH93ZNACTIB
XANTHIUM STRUMARIUM POLLEN2QOF601J1MACTIB
BASSIA SCOPARIA POLLEN07A108ZKW5ACTIB
SOLIDAGO CANADENSIS POLLEN644CZ16IR5ACTIB
SARCOBATUS VERMICULATUS POLLEN6532U64A3XACTIB

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
2cf5ee58-4bc5-d3a5-e063-6294a90a4903e521ee16-2370-498c-9b20-2780e3b91e0b2025-01-30WarningsExact identifier
spl set id: e521ee16-2370-498c-9b20-2780e3b91e0b

Reported adverse events (FAERS/openFDA)#

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