Sleepology Tablet, Chewable
FDA Label NDC 69676-0012

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 Sleepology (NDC 69676-0012). 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 EVALUATED BY THE FOOD AND DRUG ADMINISTRATION.
** X is a homeopathic dilution: see genexa.com for more information.

Bottle is safety sealed. DO NOT use if 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-20200804

NDC 69676-0012-1

Otc - Active Ingredient

Active ingredients ^‡**

Alfalfa 6X HPUS

Avena sativa 6X HPUS

Chamomilla 6X HPUS

Eschscholtzia californica 6X HPUS

Gelsemium sempervirens 12X HPUS

Nux moschata 9X HPUS

Passiflora incarnata 6X HPUS

Piper methysticum 6X HPUS

Valeriana officinalis 6X HPUS

‡ Certified Organic

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

Otc - Purpose

Purpose

restless sleep

sleeplessness from nervousness and exhaustion

inability to fall asleep

sleeplessness from stress

sleeplessness from pain, irritability and excitability

frequent waking

sleeplessness from worries and restlessness

inability to fall asleep

restless sleep

Indications & Usage

Uses*

addresses sleeplessness and/or restless sleep.

Warnings

Otc - Stop Use

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

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, 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 bedtime
do not swallow whole

children 3-11 years of age

chew 1 tablet at bedtime
do not swallow whole

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 carnuaba 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

Sleepology

Deep and Restful Sleep*

Relax and Sweet Dreams*

Wake Up Refreshed*

Organic Nighttime Sleep Aid*

Non-Habit Forming & Melatonin-Free

Flavored with Organic Vanilla & Lavender

No allergens, dyes or parabens

60 Chewable Tablets

* Please review the disclaimer below.

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