Kids' Sleepology

Kids' Sleepology
SPL v4
SPL
SPL Set ID ba0cd3c2-9883-9664-e053-2995a90a9fd4
Route
ORAL
Published
Effective Date 2021-10-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Eschscholzia Californica (6 [hp_X]) Passiflora Incarnata Flowering Top (8 [hp_X]) Valerian (3 [hp_X]) Matricaria Chamomilla Whole (12 [hp_X]) Phosphate Ion Scutellaria Lateriflora Top Melissa Officinalis Leaf Pulsatilla Vulgaris Alfalfa
Inactive Ingredients
Carnauba Wax Maltodextrin Rice Bran Dextrose

Identifiers & Packaging

Pill Appearance
Imprint: G Shape: round Color: white Size: 10 mm Score: 1
Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2021-01-28

Description

Keep outer package for complete product information Drug Facts


Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses*

addresses sleeplessness and/or restless sleep.

Dosage and Administration

Directions

children 3-11 years of age
  • chew 2 tablets at bedtime
  • do not swallow whole
children under 3 years of age ask a doctor before use

Description

Keep outer package for complete product information Drug Facts

Section 42229-5

Keep outer package for complete product information

Drug Facts

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, vanilla lavender flavor

Section 51945-4

Genexa

Homeopathic

Kids' Sleepology

Deep and Restful Sleep*

Relax and Sweet Dreams*

Wake Up Refreshed*

Organic Nighttime Sleep Aid*

Non-Habit Forming and Melatonin-Free

Made with Vanilla Lavender Flavor

No common allergens, artificial dyes or parabens

60 Chewable Tablets

Ages 3-11

Section 53413-1

Questions?

1-855-436-3921

Section 55105-1

Purpose

restless sleep

frequent waking

inability to fall asleep

sleeplessness

restless sleep

sleeplessness from restlessness, worries and exhaustion

frequent waking

sleeplessness from nervousness and excitability

restless sleep

Section 55106-9

Active ingredients‡**

Alfalfa 6X HPUS

Calcarea phosphorica 8X HPUS

Chamomilla 6X HPUS

Eschscholtzia californica 6X HPUS

Melissa officinalis 3X HPUS

Passiflora incarnata 6X HPUS

Pulsatilla 12X HPUS

Scutellaria lateriflora 3X 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

children 3-11 years of age
  • chew 2 tablets at bedtime
  • do not swallow whole
children under 3 years of age ask a doctor before use

Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

Keep outer package for complete product information

Drug Facts

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, vanilla lavender flavor

Section 51945-4 (51945-4)

Genexa

Homeopathic

Kids' Sleepology

Deep and Restful Sleep*

Relax and Sweet Dreams*

Wake Up Refreshed*

Organic Nighttime Sleep Aid*

Non-Habit Forming and Melatonin-Free

Made with Vanilla Lavender Flavor

No common allergens, artificial dyes or parabens

60 Chewable Tablets

Ages 3-11

Section 53413-1 (53413-1)

Questions?

1-855-436-3921

Section 55105-1 (55105-1)

Purpose

restless sleep

frequent waking

inability to fall asleep

sleeplessness

restless sleep

sleeplessness from restlessness, worries and exhaustion

frequent waking

sleeplessness from nervousness and excitability

restless sleep

Section 55106-9 (55106-9)

Active ingredients‡**

Alfalfa 6X HPUS

Calcarea phosphorica 8X HPUS

Chamomilla 6X HPUS

Eschscholtzia californica 6X HPUS

Melissa officinalis 3X HPUS

Passiflora incarnata 6X HPUS

Pulsatilla 12X HPUS

Scutellaria lateriflora 3X 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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