Kids' Calm Keeper

Kids' Calm Keeper
SPL v4
SPL
SPL Set ID ba5de524-dac6-8b54-e053-2995a90ac6ef
Route
ORAL
Published
Effective Date 2025-11-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Calcium Cation (8 [hp_X]) Matricaria Chamomilla Whole (6 [hp_X]) Gelsemium Sempervirens Root (12 [hp_X]) Strychnos Ignatii Seed (3 [hp_X]) Carbonate Ion Valerian Passiflora Incarnata Flowering Top Aconitum Napellus
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 2021-02-01

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses*

addresses the following symptoms associated with stress:

  • irritability
  • sleeplessness
  • restlessness
  • nervousness
  • oversensitivity
Dosage and Administration

Directions

children 3-11 years of age
  • chew 2 tablets at the onset of symptoms
  • do not swallow whole
  • repeat every 6 hours as needed
children under 3 years of age ask a doctor before use
Description

Drug Facts

Section 42229-5

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

Section 51945-4

Genexa ®

Ages 3-11

Kids' Calm Keeper

Non-Habit Forming

Organic Calming and Relaxation Formula*

Deep & Restful Sleep*

Wake Up Refreshed*

Relax & Sweet Dreams*

Know your ingredients

Made without: common allergens, artificial sweeteners or parabens

Homeopathic

60 Chewable Tablets

Vanilla Lavender Flavor

Section 53413-1

Questions?

1-855-436-3921

Section 55105-1

Purpose*

stress and tension

worry, stress and sleeplessness

irritability and restlessness

fatigue and restlessness

tension and inability to think clearly

oversensitivity and irritability

restless sleep and worry

fatigue and stress

Section 55106-9

Active ingredients‡**

Aconitum napellus 12X HPUS

Calcarea phosphorica 8X HPUS

Chamomilla 6X HPUS

Gelsemium sempervirens 12X HPUS

Ignatia amara 12X HPUS

Kali carbonicum 8X HPUS

Passiflora incarnata 3X HPUS

Valeriana officinalis 3X HPUS

‡ Organic

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


Structured Label Content

Indications and Usage (34067-9)

Uses*

addresses the following symptoms associated with stress:

  • irritability
  • sleeplessness
  • restlessness
  • nervousness
  • oversensitivity
Dosage and Administration (34068-7)

Directions

children 3-11 years of age
  • chew 2 tablets at the onset of symptoms
  • do not swallow whole
  • repeat every 6 hours as needed
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 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 carnauba wax, organic dextrose, organic maltodextrin, organic rice bran extract, natural vanilla lavender flavor

Section 51945-4 (51945-4)

Genexa ®

Ages 3-11

Kids' Calm Keeper

Non-Habit Forming

Organic Calming and Relaxation Formula*

Deep & Restful Sleep*

Wake Up Refreshed*

Relax & Sweet Dreams*

Know your ingredients

Made without: common allergens, artificial sweeteners or parabens

Homeopathic

60 Chewable Tablets

Vanilla Lavender Flavor

Section 53413-1 (53413-1)

Questions?

1-855-436-3921

Section 55105-1 (55105-1)

Purpose*

stress and tension

worry, stress and sleeplessness

irritability and restlessness

fatigue and restlessness

tension and inability to think clearly

oversensitivity and irritability

restless sleep and worry

fatigue and stress

Section 55106-9 (55106-9)

Active ingredients‡**

Aconitum napellus 12X HPUS

Calcarea phosphorica 8X HPUS

Chamomilla 6X HPUS

Gelsemium sempervirens 12X HPUS

Ignatia amara 12X HPUS

Kali carbonicum 8X HPUS

Passiflora incarnata 3X HPUS

Valeriana officinalis 3X HPUS

‡ Organic

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)