Genexa Stress Tablet, Chewable
FDA Label NDC 69676-0048

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Genexa Inc. for the product Genexa Stress (NDC 69676-0048). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Otc - Active Ingredient

→ Otc - Purpose

→ Indications & Usage

→ Warnings

→ Otc - Stop Use

→ Otc - Pregnancy Or Breast Feeding

→ Otc - Keep Out Of Reach Of Children

→ Dosage & Administration

→ Storage And Handling

→ Inactive Ingredient

→ Otc - Questions

→ Package Label.principal Display Panel

Other

Keep outer package for complete product information

Drug Facts

*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.

Bottle is safety sealed. DO NOT use if bottle seal is disturbed or missing.

Distributed by: Genexa Inc.

Los Angeles, CA 90034

genexa.com

Certified Organic by SCS Global Services

Made in the USA with globally sourced ingredients.

R-20200803

NDC 69676-0048-1

Otc - 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

‡ Certified Organic

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

Otc - 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

Otc - Stop Use

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

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

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 age

ask 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 compliant vanilla lavender flavor, organic maltodextrin, organic rice bran extract, organic tapioca dextrose

Otc - Questions

Questions?

1-855-436-3921

Mon.-Fri. 7am - 6pm PST

Package Label.Principal Display Panel

Genexa

REAL REMEDIES MADE CLEAN

Homeopathic

Stress

Anxiety & Irritabilty*

Fatigue*

Sleeplessness*

Organic Stress and Fatigue Formula*

Non-Drowsy and Non-Habit Forming

Flavored with Organic Vanilla and Lavender

No allergens, dyes, or parabens

60 Chewable Tablets

* Please review the disclaimer below.

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