FDA.reportPublic FDA data

Genexa Kids Calm Keeper

Manufacturer
Genexa Inc.
Effective date
2025-11-25
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:35:28

Label at a glance#

ProductGenexa Kids Calm Keeper
Active ingredientTRIBASIC CALCIUM PHOSPHATE, MATRICARIA CHAMOMILLA WHOLE, GELSEMIUM SEMPERVIRENS ROOT, STRYCHNOS IGNATII SEED, POTASSIUM CARBONATE, VALERIAN, PASSIFLORA INCARNATA FLOWERING TOP, ACONITUM NAPELLUS
Label structure13 sections

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

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.

OTC - PURPOSE SECTION

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 SECTION

Uses*

addresses the following symptoms associated with stress:

  • irritability
  • sleeplessness
  • restlessness
  • nervousness
  • oversensitivity

WARNINGS SECTION

Warnings

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

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 ageask 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 carnauba 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.

NOTE: THIS PRODUCT IS NOT INTENDED TO TREAT ADHD, AUTISM, OR ANXIETY DISORDERS
** 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 69676-0054-1

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

8A Carton_202412188A Carton_20241218

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130857630006106GTIN-13: 0857630006106
EAN-13: 0857630006106
GTIN-12: 857630006106
UPC-A: 857630006106
GTIN storage (14 digits): 00857630006106		8A Carton_20241218.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69676-0054-12025-11-25C16284748780-12cef2736-839c-d83d-e063-dadaa90ab31fKIDS' CALM KEEPER
69676-0054-12025-01-30C16284748780-12cef2736-839c-d83d-e063-dadaa90ab31fKIDS' CALM KEEPER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69676-0054-1Genexa Kids Calm Keeper1 in 1 CARTONTABLET, CHEWABLE14
69676-0054-1Genexa Kids Calm Keeper60 in 1 BOTTLE, PLASTICTABLET, CHEWABLE604

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69676-005469676-0054-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28ACTIM
MATRICARIA CHAMOMILLA WHOLE2Z4LRR776SACTIB
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB
STRYCHNOS IGNATII SEED1NM3M2487KACTIB
POTASSIUM CARBONATEBQN1B9B9HAACTIB
VALERIANJWF5YAW3QWACTIB
PASSIFLORA INCARNATA FLOWERING TOPCLF5YFS11OACTIB
CARNAUBA WAXR12CBM0EIZIACT
MALTODEXTRIN7CVR7L4A2DIACT
RICE BRANR60QEP13ICIACT
DEXTROSEIY9XDZ35W2IACT
ACONITUM NAPELLUSU0NQ8555JDACTIB

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Genexa Kids Calm KeeperACONITUM NAPELLUS, CALCAREA PHOSPHORICA, CHAMOMILLA, GELSEMIUM SEPERVIRENS, IGNATIA AMARA, KALI CARBONICUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALISGenexa Inc.ba5de524-dac6-8b54-e053-2995a90ac6ef2025-11-25WarningsExact identifier
ndc (package): 69676-0054-1
ndc (product): 69676-0054
ndc11 (package): 69676005401
spl id: 4471ce51-53e1-f3bd-e063-6294a90a4898
spl set id: ba5de524-dac6-8b54-e053-2995a90ac6ef

Reported adverse events (FAERS/openFDA)#

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