Genexa Stress

Manufacturer
Genexa Inc.
Effective date
2025-04-02
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 02:33:08

Label at a glance#

ProductGenexa Stress
Active ingredientSTRYCHNOS NUX-VOMICA SEED, VALERIAN, ACONITUM NAPELLUS, OYSTER SHELL CALCIUM CARBONATE, CRUDE, LYCOPODIUM CLAVATUM SPORE, PASSIFLORA INCARNATA FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT
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‡**

Aconitum napellus 12X HPUS

Calcarea carbonica 8X HPUS

Gelsemium sempervirens 12X HPUS

Lycopodium clavatum 12X HPUS

Nux vomica 12X HPUS

Passiflora incarnata 3X HPUS

Valeriana officinalis 3X HPUS

‡ Organic

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

OTC - PURPOSE SECTION

Purpose*

stress, agitation and hypersensitivity

anxiety and sleeplessness

fatigue and restlessness

irritability and anticipatory anxiety

apprehensiveness and inability to think clearly

restless sleep and stress

nervousness & digestive symptoms due to stress

INDICATIONS & USAGE SECTION

Uses*

address symptoms associated with stress, such as:

  • fatigue
  • nervousness
  • anxiousness
  • irritability
  • hypersensitivity

WARNINGS SECTION

Warnings

OTC - STOP USE SECTION

Stop use and ask a doctor if symptoms 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 onset of symptoms
  • chew tablets before swallowing; do not swallow whole
  • repeat every 8 hours as needed

adults and children 12 years of age

and older

2 tablets

children 3-11 years of age

1 tablet

children under 3 years of ageask 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

organic carnauba wax, organic dextrose, organic maltodextrin, organic rice bran extract, natural vanilla lavender flavor

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 ADMINSTRATION.
** 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 imprinted seal under the cap is broken or missing.

Patent Pending | 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 69676-0048-1

RECENT MAJOR CHANGES SECTION

Directions

  • take dose at onset of symptoms
  • chew tablets before swallowing; do not swallow whole
  • repeat every 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®

Stress

Non-Drowsy and Non-Habit Forming

Organic Stress & Fatigue Formula*

Anxiety & Irritabilty*

Fatigue*

Sleeplessness*

Know your ingredients

Made without: common allergens, artificial dyes, or parabens

Homeopathic

60 Chewable Tablets

Vanilla Lavender Flavor

7A_Carton_R-202311217A_Carton_R-20231121

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
69676-0048-12025-02-26C16284748780-12cef2736-72b3-d83d-e063-dadaa90ab31fSTRESS
69676-0048-32025-02-26C16284748780-12cef2736-72b3-d83d-e063-dadaa90ab31fSTRESS
69676-0048-12025-01-30C16284748780-12cef2736-72b3-d83d-e063-dadaa90ab31fSTRESS
69676-0048-32025-01-30C16284748780-12cef2736-72b3-d83d-e063-dadaa90ab31fSTRESS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69676-0048-1Genexa Stress1 in 1 CARTONTABLET, CHEWABLE16
69676-0048-1Genexa Stress60 in 1 BOTTLE, PLASTICTABLET, CHEWABLE606
69676-0048-3Genexa Stress2 in 1 POUCHTABLET, CHEWABLE26

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69676-0048GENEXA STRESS (ACONITUM NAPELLUS, CALCAREA CARBONICA, GELSEMIUM SEMPERVIRENS, LYCOPODIUM CLAVATUM, NUX VOMICA, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS) TABLET, CHEWABLE [GENEXA INC.]6Current NDC, Legacy NDC, 3 package rows20250406_b86a2e37-fbc0-7c31-e053-2a95a90ad5d0.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69676-004869676-0048-1, 69676-0048-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

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
Genexa StressACONITUM NAPELLUS, CALCAREA CARBONICA, GELSEMIUM SEMPERVIRENS, LYCOPODIUM CLAVATUM, NUX VOMICA, PASSIFLORA INCARNATA, VALERIANA OFFICINALISGenexa Inc.b86a2e37-fbc0-7c31-e053-2a95a90ad5d02025-04-02WarningsExact identifier
ndc (package): 69676-0048-3
ndc (package): 69676-0048-1
ndc (product): 69676-0048
ndc11 (package): 69676004803
ndc11 (package): 69676004801
spl id: 31cbff6a-30bd-df7a-e063-6394a90aee99
spl set id: b86a2e37-fbc0-7c31-e053-2a95a90ad5d0

Reported adverse events (FAERS/openFDA)#

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