GENEXA KIDS CALM KEEPER- aconitum napellus, calcarea phosphorica, chamomilla, gelsemium sepervirens, ignatia amara, kali carbonicum, passiflora incarnata, valeriana officinalis tablet, chewable

Genexa Kids Calm Keeper by

Drug Labeling and Warnings

Genexa Kids Calm Keeper by is a Homeopathic medication manufactured, distributed, or labeled by Genexa Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Keep outer package for complete product information

Drug Facts

ACTIVE INGREDIENT

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.

PURPOSE

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

INDICATIONS & USAGE

Uses*

addresses the following symptoms associated with stress:

• irritability
• sleeplessness
• restlessness
• nervousness
• oversensitivity

WARNINGS

Warnings

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

Keep out of reach of children.

DOSAGE & 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

STORAGE AND HANDLING

Other information

store between 29-25° C (68-77° F) in a dry place out of direct sunlight

INACTIVE INGREDIENT

Inactive ingredients

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

QUESTIONS

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.

NOTE: THIS PRODUCT IS NOT INTENDED TO TREAT ADHD, AUTISM, OR ANXIETY DISORDERS
** X is a homeopathic dilution: see genexa.com for more information.

SPL UNCLASSIFIED SECTION

Bottle is safety sealed. DO NOT use if bottle seal is disturbed or missing.

Patent Pending | Distributed by:

Genexa Inc. Atlanta, GA 30318

genexa.com

Certified Organic by SCS Global Services

SPL UNCLASSIFIED SECTION

Made in the USA with globally sourced ingredients

R-20210624

NDC: 69676-0054-1

PRINCIPAL DISPLAY PANEL

Genexa

Homeopathic

Kids' Calm Keeper

Eases Worries & Tension*

Reduces Fatigue*

Lessens Irritability*

Organic Calming and Relaxation Formula*

Non-Habit Forming

Made with Vanilla Lavender Flavor

No common allergens, artificial dyes or parabens

60 Chewable Tablets

Ages 3+

INGREDIENTS AND APPEARANCE

GENEXA KIDS CALM KEEPER 
aconitum napellus, calcarea phosphorica, chamomilla, gelsemium sepervirens, ignatia amara, kali carbonicum, passiflora incarnata, valeriana officinalis tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69676-0054
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	8 [hp_X]
MATRICARIA CHAMOMILLA WHOLE (UNII: 2Z4LRR776S) (MATRICARIA CHAMOMILLA WHOLE - UNII:2Z4LRR776S)	MATRICARIA CHAMOMILLA WHOLE	6 [hp_X]
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q)	GELSEMIUM SEMPERVIRENS ROOT	12 [hp_X]
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K)	STRYCHNOS IGNATII SEED	12 [hp_X]
POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D)	POTASSIUM CARBONATE	8 [hp_X]
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW)	VALERIAN	3 [hp_X]
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O)	PASSIFLORA INCARNATA FLOWERING TOP	3 [hp_X]
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	12 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
CARNAUBA WAX (UNII: R12CBM0EIZ)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
RICE BRAN (UNII: R60QEP13IC)
DEXTROSE (UNII: IY9XDZ35W2)

Product Characteristics
Color	white (Off-white)	Score	no score
Shape	ROUND	Size	10mm
Flavor	VANILLA (Lavender)	Imprint Code	G
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69676-0054-1	1 in 1 CARTON	02/01/2021
1		60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		02/01/2021

Labeler - Genexa Inc. (079751024)