FDA.reportPublic FDA data

ALLERGY CARE

Manufacturer
Genexa Inc.
Effective date
2026-08-22
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
daily-update
Hydrated at
2026-09-01 13:01:30

Label at a glance#

ProductGenexa Allergy Care
Active ingredientAMBROSIA ARTEMISIIFOLIA, STRYCHNOS NUX-VOMICA SEED, BLACK MUSTARD SEED, LOBARIA PULMONARIA, ARUNDO PLINIANA ROOT, RANUNCULUS BULBOSUS WHOLE, PULSATILLA PRATENSIS, SCHOENOCAULON OFFICINALE SEED, SOLANUM DULCAMARA TOP, EUPHRASIA STRICTA, WYETHIA HELENIOIDES ROOT, ALLIUM CEPA WHOLE
Label structure14 sections

Storage and handling

Other information store between 20-25°C (68-77°F) in a dry place out of direct sunlight

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients**

Allium cepa 12X HPUS

Ambrosia artemisiifolia 12X HPUS

Arundo mauritanica 12X HPUS

Dulcamara 12X HPUS

Euphrasia officinalis 12X HPUS

Nux vomica 12X HPUS

Pulsatilla 12X HPUS

Ranunculus bulbosus 12X HPUS

Sabadilla 12X HPUS

Sinapis nigra 12X HPUS

Sticta pulmonaria 12X HPUS

Wyethia helenioides 12X HPUS

"HPUS" indicates that this ingredient is officially included in the Homeopathic Pharmacopoeia of the United States.

OTC - PURPOSE SECTION

Purpose*

sneezing and runny nose

sneezing

burning in nose, throat and eyes

cough

irritated eyes

itchy nose and throat

itchy eyes and watery eyes

allergic headache

allergy symptoms

runny nose

sinus pressure

nasal congestion

INDICATIONS & USAGE SECTION

Uses*

addresses symptoms associated with hay fever or other upper respiratory allergies, such as:

  • sneezing
  • runny nose
  • itchy, watery eyes
  • nasal congestion
  • itchy nose & throat

WARNINGS SECTION

Warnings

OTC - STOP USE SECTION

Stop use and ask a doctorifsymptoms persist for more than 3 days or worsen.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

Directions

  • take dose at the onset of symptoms
  • chew tablets before swallowing
  • do not swallow whole
  • repeat dose every 6-8 hours as needed

adults and children 12 years of age

& older

 2 tablets
children 3-11 years of age 1 tablet
children under 3 years of age ask a doctor before use

STORAGE AND HANDLING SECTION

Other information

store between 20-25°C (68-77°F) in a dry place out of direct sunlight

INACTIVE INGREDIENT SECTION

Inactive ingredients

carnauba wax (organic), dextrose (organic), açaí berry flavor (organic), maltodextrin (organic), rice bran extract (organic)

OTC - QUESTIONS SECTION

Questions?

1-855-436-3921

SPL UNCLASSIFIED SECTION

* CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT EVALUATED BY THE FOOD AND DRUG ADMINISTRATION.

** X is a homeopathic dilution; see genexa.com/faq for more information.

SPL UNCLASSIFIED SECTION

Do not use if perforated band around the bottle or seal under the cap is broken or missing.

Distributed by: Genexa Inc.

Atlanta, GA 30324 genexa.com

Certified Organic by SCS Global Services

SPL UNCLASSIFIED SECTION

Made in the USA with globally sourced ingredients

NDC 69676-0052-1

RECENT MAJOR CHANGES SECTION

Uses*

addresses symptoms associated with hay fever or other upper respiratory allergies, such as:

  • sneezing
  • runny nose
  • itchy, watery eyes
  • nasal congestion
  • itchy nose & throat

Directions

  • take dose at the onset of symptoms
  • chew tablets before swallowing
  • do not swallow whole
  • repeat dose every 6-8 hours as needed
    adults and children 12 years of age & older2 tablets
    children 3-11 years of age1 tablet
    children under 3 years of ageask a doctor before use

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Genexa ®

CLEAN MEDICINE

Allergy Care

Homeopathic Multi-Syptom Allergy Formula*

Sneezing & Runny Nose*

Itchy, Watery Eyes*

Nasal Congestion*

Itchy Nose & Throat*

0% Artificial Additives, Dyes, Artificial Sweeteners, Common Allergens

Made with Organic Açai Berry Flavoring

Homeopathic

60 Chewable Tablets

3A_Carton_R-202603273A_Carton_R-20260327

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130857630006052GTIN-13: 0857630006052
EAN-13: 0857630006052
GTIN-12: 857630006052
UPC-A: 857630006052
GTIN storage (14 digits): 00857630006052		3A_Carton_R-20260327.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69676-0052-12025-02-26C16284748780-12cef2736-9435-d83d-e063-dadaa90ab31fALLERGY CARE
69676-0052-12025-02-26C16284748780-12cef2736-9435-d83d-e063-dadaa90ab31fALLERGY CARE
69676-0052-12025-02-26C16284748780-12cef2736-9435-d83d-e063-dadaa90ab31fALLERGY CARE
69676-0052-32025-02-26C16284748780-12cef2736-9435-d83d-e063-dadaa90ab31fALLERGY CARE
69676-0052-32025-02-26C16284748780-12cef2736-9435-d83d-e063-dadaa90ab31fALLERGY CARE
69676-0052-32025-02-26C16284748780-12cef2736-9435-d83d-e063-dadaa90ab31fALLERGY CARE
69676-0052-12025-01-30C16284748780-12cef2736-9435-d83d-e063-dadaa90ab31fALLERGY CARE
69676-0052-12025-01-30C16284748780-12cef2736-9435-d83d-e063-dadaa90ab31fALLERGY CARE
69676-0052-12025-01-30C16284748780-12cef2736-9435-d83d-e063-dadaa90ab31fALLERGY CARE
69676-0052-32025-01-30C16284748780-12cef2736-9435-d83d-e063-dadaa90ab31fALLERGY CARE
69676-0052-32025-01-30C16284748780-12cef2736-9435-d83d-e063-dadaa90ab31fALLERGY CARE
69676-0052-32025-01-30C16284748780-12cef2736-9435-d83d-e063-dadaa90ab31fALLERGY CARE

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69676-005269676-0052-1, 69676-0052-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
AMBROSIA ARTEMISIIFOLIA9W34L2CQ9AACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
BLACK MUSTARD SEED8LTY55LQ8DACTIB
LOBARIA PULMONARIAD1YM0P5Z2TACTIB
ARUNDO PLINIANA ROOTZXE7LB03WCACTIB
RANUNCULUS BULBOSUS WHOLEAEQ8NXJ0MBACTIB
PULSATILLA PRATENSIS8E272251DIACTIB
SCHOENOCAULON OFFICINALE SEED6NAF1689IOACTIB
SOLANUM DULCAMARA TOPKPS1B1162NACTIB
EUPHRASIA STRICTAC9642I91WLACTIB
WYETHIA HELENIOIDES ROOTJ10PD1AQ0NACTIB
ALLIUM CEPA WHOLE8P2VLG2456ACTIB
RICE BRANR60QEP13ICIACT
DEXTROSEIY9XDZ35W2IACT
CARNAUBA WAXR12CBM0EIZIACT
MALTODEXTRIN7CVR7L4A2DIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
102026-05-28daily-update2026-06-03 18:03:24
92025-04-03full-release2026-06-01 02:33:07

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
Genexa Allergy CareALLIUM CEPA, AMBROSIA ARTEMISIIFOLIA, ARUNDO MAURITANICA, DULCAMARA, EUPHRASIA OFFICINALIS, NUX VOMICA, PULSATILLA, RANUNCULUS BULBOSUS, SABADILLA, SINAPIS NIGRA, STICTA PULMONARIA, WYETHIA HELENOIDESGenexa Inc.b5fddd8f-a380-6e88-e053-2a95a90a6b892026-08-22WarningsExact identifier
ndc (package): 69676-0052-3
ndc (package): 69676-0052-1
ndc (product): 69676-0052
ndc11 (package): 69676005201
ndc11 (package): 69676005203
spl id: 59af45df-ac36-9901-e063-6294a90a71aa
spl set id: b5fddd8f-a380-6e88-e053-2a95a90a6b89

Reported adverse events (FAERS/openFDA)#

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