Sleepology

Manufacturer: Genexa Inc.
Effective date: 2025-04-02
Label type: HUMAN OTC DRUG LABEL
Version: 15
Source: full-release
Hydrated at: 2026-06-01 02:33:02

Label at a glance#

ProductSleepology

Active ingredientAVENA SATIVA FLOWERING TOP, ALFALFA, ESCHSCHOLZIA CALIFORNICA, PASSIFLORA INCARNATA FLOWERING TOP, NUTMEG, VALERIAN, PIPER METHYSTICUM ROOT, GELSEMIUM SEMPERVIRENS ROOT, MATRICARIA CHAMOMILLA WHOLE

Label structure17 sections

Storage and handling

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

Contacts and useful links#

PhoneLabel contact1-855-436-3921

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients ^‡**

Alfalfa 6X HPUS

Avena sativa 6X HPUS

Chamomilla 6X HPUS

Eschscholzia californica 6X HPUS

Gelsemium sempervirens 12X HPUS

Nux moschata 9X HPUS

Passiflora incarnata 6X HPUS

Piper methysticum 6X HPUS

Valeriana officinalis 6X HPUS

‡ Organic

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

OTC - PURPOSE SECTION

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 SECTION

Uses*

addresses sleeplessness and/or restless sleep.

WARNINGS SECTION

Warnings

OTC - STOP USE SECTION

Stop use and ask a doctorif 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 bedtime
chew tablets before swallowing; do not swallow whole

adults and children 12 years of age and 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

organic carnuaba 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 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 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 69676-0012-1

RECENT MAJOR CHANGES SECTION

Directions

take dose at bedtime
chew tablets before swallowing; do not swallow whole

adults and children 12 years of age and older	2 tablets
children 3-11 years of age	1 tablet
children under 3 years of age	ask a doctor before use

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Genexa®

Sleepology

Non-Habit Forming & Melatonin-Free

Organic Nighttime Sleep Aid*

Deep and Restful Sleep*

Wake Up Refreshed*

Relax and Sweet Dreams*

Know your ingredients

Made without: common allergens, artificial sweeteners or parabens

Homeopathic

Vanilla Lavender Flavor

60 Chewable Tablets

5A_Carton_R-20240624

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69676-0012-1	2025-02-26	C162847	48780-1	2cef2736-ab58-d83d-e063-dadaa90ab31f	SLEEPOLOGY
69676-0012-3	2025-02-26	C162847	48780-1	2cef2736-ab58-d83d-e063-dadaa90ab31f	SLEEPOLOGY
69676-0012-1	2025-01-30	C162847	48780-1	2cef2736-ab58-d83d-e063-dadaa90ab31f	SLEEPOLOGY
69676-0012-3	2025-01-30	C162847	48780-1	2cef2736-ab58-d83d-e063-dadaa90ab31f	SLEEPOLOGY

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
69676-0012-1	Sleepology	60 in 1 BOTTLE, PLASTIC	TABLET, CHEWABLE	60	15
69676-0012-1	Sleepology	1 in 1 CARTON	TABLET, CHEWABLE	1	15
69676-0012-3	Sleepology	2 in 1 POUCH	TABLET, CHEWABLE	2	15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69676-0012	SLEEPOLOGY (ALFALFA, AVENA SATIVA, CHAMOMILLA, ESCHSCHOLTZIA CALIFORNICA, GELSEMIUM SEMPERVIRENS, NUX MOSCHATA, PASSIFLORA INCARNATA, PIPER METHYSTICUM, VALERIANA OFFICINALIS) TABLET, CHEWABLE [GENEXA INC.]	15	Current NDC, Legacy NDC, 3 package rows	20250406_1e11f655-374c-59ac-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

Sleepology
Alfalfa, Avena sativa, Chamomilla, Eschscholtzia californica, Gelsemium sempervirens, Nux moschata, Passiflora incarnata, Piper methysticum, Valeriana officinalis
AVENA SATIVA FLOWERING TOP
DEXTROSE
ALFALFA
ESCHSCHOLZIA CALIFORNICA
CARNAUBA WAX
MALTODEXTRIN
RICE BRAN
PASSIFLORA INCARNATA FLOWERING TOP
NUTMEG
VALERIAN
PIPER METHYSTICUM ROOT
GELSEMIUM SEMPERVIRENS ROOT
MATRICARIA CHAMOMILLA WHOLE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
69676-0012	69676-0012-1, 69676-0012-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
AVENA SATIVA FLOWERING TOP	MA9CQJ3F7F	ACTIB
DEXTROSE	IY9XDZ35W2	IACT
ALFALFA	DJO934BRBD	ACTIB
ESCHSCHOLZIA CALIFORNICA	9315HN272X	ACTIB
CARNAUBA WAX	R12CBM0EIZ	IACT
MALTODEXTRIN	7CVR7L4A2D	IACT
RICE BRAN	R60QEP13IC	IACT
PASSIFLORA INCARNATA FLOWERING TOP	CLF5YFS11O	ACTIB
NUTMEG	AEE24M3MQ9	ACTIB
VALERIAN	JWF5YAW3QW	ACTIB
PIPER METHYSTICUM ROOT	BOW48C81XP	ACTIB
GELSEMIUM SEMPERVIRENS ROOT	639KR60Q1Q	ACTIB
MATRICARIA CHAMOMILLA WHOLE	2Z4LRR776S	ACTIB

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sleepology	ALFALFA, AVENA SATIVA, CHAMOMILLA, ESCHSCHOLTZIA CALIFORNICA, GELSEMIUM SEMPERVIRENS, NUX MOSCHATA, PASSIFLORA INCARNATA, PIPER METHYSTICUM, VALERIANA OFFICINALIS	Genexa Inc.	1e11f655-374c-59ac-e054-00144ff8d46c	2025-04-02	Warnings	Exact identifier ndc (package): 69676-0012-3 ndc (package): 69676-0012-1 ndc (product): 69676-0012 ndc11 (package): 69676001201 ndc11 (package): 69676001203 spl id: 31cc448e-4472-22fa-e063-6294a90a360f spl set id: 1e11f655-374c-59ac-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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