Storage and handling
Other information store between 15-30° C (59-86° F) in a dry place out of direct sunlight
Calm Keeper
- Manufacturer
- Genexa Inc.
- Effective date
- 2021-02-02
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 6
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:54:02
Label at a glance#
ProductCalm Keeper
Active ingredientTRIBASIC CALCIUM PHOSPHATE, MATRICARIA CHAMOMILLA WHOLE, GELSEMIUM SEMPERVIRENS ROOT, STRYCHNOS IGNATII SEED, POTASSIUM CARBONATE, VALERIAN, PASSIFLORA INCARNATA FLOWERING TOP, ACONITUM NAPELLUS
Label structure15 sections
Contacts and useful links#
Websitewww.genexa.com
www.genexa.com
www.genexa.comLabel contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredients** (in each tablet)
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
‡ Certified Organic
"HPUS" indicates that this ingredient is officially included in the Homeopathic Pharmacopoeia of the United States.
OTC - PURPOSE SECTION
Purpose
stress, agitation and hypersensitivity
anxiety and sleeplessness
irritability and restlessness
fatigue and restlessness
inability to think clearly
oversensitivity and irritability
restless sleep and stress
nervousness & digestive symptoms due to stress
INDICATIONS & USAGE SECTION
Uses*
addresses the following symptoms:
- irritability
- restlessness
- oversensitivity
- sleeplessness
- nervousness
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 age: ask a doctor before use
STORAGE AND HANDLING SECTION
Other information
store between 15-30° C (59-86° F) in a dry place out of direct sunlight
INACTIVE INGREDIENT SECTION
Inactive ingredients
organic carnauba wax, organic compliant natural flavor, organic dextrose, organic maltodextrin, organic rice bran extract
SPL UNCLASSIFIED SECTION
* CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
** X is a homeopathic dilution: see www.genexa.com for more information.
Patent Pending
MADE IN THE USA WITH GLOBALLY SOURCED INGREDIENTS
SPL UNCLASSIFIED SECTION
THE Genexa® PLEDGE
WE PLEDGE TO DELIVER THE HIGHEST QUALITY MEDICINES.
All our products are made with clean, certified organic and non-GMO Ingredients.
Genexa products maintain the highest standards in manufacturing and are made in the USA with globally sourced organic ingredients.
We pioneered the organic technology (patent pending) that eliminates harmful synthetics from our proprietary chewable tablet.
Our products are free of artificial dyes, flavors and preservatives.
Distributed by: Genexa Inc.
Beverly Hills, CA 90211
Certified Organic by SCS Global Services
OTHER SAFETY INFORMATION
BOTTLE IS SAFETY SEALED.
DO NOT USE IF BOTTLE SEAL IS DISTURBED OR MISSING.
SPL UNCLASSIFIED SECTION
Genexa®
THE HEALTHIER MEDICINE®
Genexa was founded on the belief that medicine should not only be UNQUESTIONABLY SAFE, but that it should be HEALTHY for you and your family.
We're also very proud to be a Certified B Corporation using business as a force for good.
Questions? Comments?
1-855-GENEXA-1
hello@genexa.com
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Children's
Genexa®
THE HEALTHIER MEDICINE®
NDC 69676-0008-1
Ages 3+
NO DRUG INTERACTIONS
ORGANIC & SAFE
CALM KEEPER TM
CALMING & RELAXATION*
- Restlessness & Irritability*
- Inability to Concentrate*
- Fatigue*
60 CHEWABLE TABLETS
HOMEOPATHIC
VANILLA LAVENDER FLAVOR
USDA ORGANIC
NON GMO Project VERIFIED
Products#
Every source-derived product name is available through these pages.
- Calm Keeper
- Aconitum napellus, Calcarea phosphorica, Chamomilla, Gelsemium sepervirens, Ignatia amara, Kali carbonicum, Passiflora incarnata, Valeriana officinalis
- TRIBASIC CALCIUM PHOSPHATE
- CALCIUM CATION
- MATRICARIA CHAMOMILLA WHOLE
- GELSEMIUM SEMPERVIRENS ROOT
- STRYCHNOS IGNATII SEED
- POTASSIUM CARBONATE
- CARBONATE ION
- VALERIAN
- PASSIFLORA INCARNATA FLOWERING TOP
- CARNAUBA WAX
- MALTODEXTRIN
- RICE BRAN
- DEXTROSE
- ACONITUM NAPELLUS
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69676-0008 | 69676-0008-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| TRIBASIC CALCIUM PHOSPHATE | 91D9GV0Z28 | ACTIM |
| MATRICARIA CHAMOMILLA WHOLE | 2Z4LRR776S | ACTIB |
| GELSEMIUM SEMPERVIRENS ROOT | 639KR60Q1Q | ACTIB |
| STRYCHNOS IGNATII SEED | 1NM3M2487K | ACTIB |
| POTASSIUM CARBONATE | BQN1B9B9HA | ACTIB |
| VALERIAN | JWF5YAW3QW | ACTIB |
| PASSIFLORA INCARNATA FLOWERING TOP | CLF5YFS11O | ACTIB |
| CARNAUBA WAX | R12CBM0EIZ | IACT |
| MALTODEXTRIN | 7CVR7L4A2D | IACT |
| RICE BRAN | R60QEP13IC | IACT |
| DEXTROSE | IY9XDZ35W2 | IACT |
| ACONITUM NAPELLUS | U0NQ8555JD | ACTIB |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| ba5e496b-e03f-b06a-e053-2995a90a9fa8 | 7900262d-90fd-6c08-e053-2991aa0a77f9 | 2021-02-02 | Warnings | ba5e496b-e03f-b06a-e053-2995a90a9fa8 7900262d-90fd-6c08-e053-2991aa0a77f9 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.