Label: GENEXA STRESS- aconitum napellus, calcarea carbonica, gelsemium sempervirens, lycopodium clavatum, nux vomica, passiflora incarnata, valeriana officinalis tablet, chewable

  • NDC Code(s): 69676-0048-1, 69676-0048-3
  • Packager: Genexa Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated December 8, 2022

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Keep outer package for complete product information

    Drug Facts

  • ACTIVE INGREDIENT

    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.

  • PURPOSE

    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

    Uses*

    address symptoms associated with stress, such as:

    • fatigue
    • nervousness
    • anxiousness
    • irritability
    • hypersensitivity
  • WARNINGS

    Warnings

    Stop use and ask a doctor if symptoms persist for more than 3 days or worsen.

    If pregnant or breastfeeding, ask a health professional before use.

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    Directions

    adults and children 12 years of age

    and older
    • chew 2 tablets at the onset of symptoms
    • do not swallow whole
    • repeat every 8 hours as needed
    children 3-11 years of age
    • chew 1 tablet at the onset of symptoms
    • do not swallow whole
    • repeat every 8 hours as needed
    children under 3 years of ageask a doctor before use

  • STORAGE AND HANDLING

    Other information

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

  • INACTIVE INGREDIENT

    Inactive ingredients

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

  • QUESTIONS

    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 for more information.

  • SPL UNCLASSIFIED SECTION

    Bottle is safety sealed with a perforated band around bottle. DO NOT use if bottle seal is disturbed or missing.

    Patent Pending | Distributed by:

    Genexa Inc. Atlanta, GA 30318

    genexa.com

    Certified Organic by SCS Global Services

  • SPL UNCLASSIFIED SECTION

    Made in the USA with globally sourced ingredients.

    R-20220210

    NDC 69676-0048-1

  • 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

    7AStressAdult 2022_02_10

  • INGREDIENTS AND APPEARANCE
    GENEXA STRESS 
    aconitum napellus, calcarea carbonica, gelsemium sempervirens, lycopodium clavatum, nux vomica, passiflora incarnata, valeriana officinalis tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69676-0048
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED12 [hp_X]
    VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN3 [hp_X]
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS12 [hp_X]
    OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE8 [hp_X]
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE12 [hp_X]
    PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP3 [hp_X]
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT12 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    RICE BRAN (UNII: R60QEP13IC)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    Product Characteristics
    Colorwhite (Off-white) Scoreno score
    ShapeROUNDSize10mm
    FlavorVANILLA (Lavender) Imprint Code G
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69676-0048-11 in 1 CARTON01/07/2021
    160 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:69676-0048-32 in 1 POUCH; Type 0: Not a Combination Product12/08/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/07/2021
    Labeler - Genexa Inc. (079751024)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!