Sleepology

Sleepology
SPL v15
SPL
SPL Set ID 1e11f655-374c-59ac-e054-00144ff8d46c
Route
ORAL
Published
Effective Date 2025-04-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avena Sativa Flowering Top (6 [hp_X]) Alfalfa (9 [hp_X]) Eschscholzia Californica (12 [hp_X]) Passiflora Incarnata Flowering Top Nutmeg Valerian Piper Methysticum Root Gelsemium Sempervirens Root Matricaria Chamomilla Whole
Inactive Ingredients
Dextrose Carnauba Wax Maltodextrin Rice Bran

Identifiers & Packaging

Pill Appearance
Imprint: G Shape: round Color: white Size: 10 mm Score: 1
Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2016-03-21

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses*

addresses sleeplessness and/or restless sleep.

Dosage and Administration

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

Description

Drug Facts

Section 42229-5

Drug Facts

Section 43683-2

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

Section 44425-7

Other information

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

Section 50565-1

Keep out of reach of children.

Section 50566-9

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

Section 51727-6

Inactive ingredients

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

Section 51945-4

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

Section 53413-1

Questions?

1-855-436-3921

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

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

Section 55106-9

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.


Structured Label Content

Indications and Usage (34067-9)

Uses*

addresses sleeplessness and/or restless sleep.

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

Drug Facts

Section 43683-2 (43683-2)

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

Section 44425-7 (44425-7)

Other information

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

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

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

Section 51727-6 (51727-6)

Inactive ingredients

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

Section 51945-4 (51945-4)

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

Section 53413-1 (53413-1)

Questions?

1-855-436-3921

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

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

Section 55106-9 (55106-9)

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.


Advanced Ingredient Data


Raw Label Data

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