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 LLC
- Effective date
- 2019-10-19
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 00:06:45
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 structure16 sections
Contacts and useful links#
Websitewww.genexahealth.com
www.genexahealth.com
www.genexahealth.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 6X HPUS
Chamomilla 6X HPUS
Gelsemium sempervirens 12X HPUS
Ignatia amara 12X HPUS
Kali carbonicum 6X HPUS
Passiflora incarnata 3X HPUS
Valeriana officinalis 3X HPUS
OTC - PURPOSE SECTION
Purpose
stress, agitation and hypersensitivity
anxiety and sleeplessness
irritability and restlessness
fatigue and restlessness
inability to concentrate and think clearly
oversensitivity and irritability
restless sleep and stress
nervousness & digestive symptoms due to stress
INDICATIONS & USAGE SECTION
Uses*
Addresses symptoms associated with stress, such as:
- Irritability
- Restlessness
- Oversensitivity
- Sleeplessness
- Inability to concentrate
- Nervousness
*These "Uses" are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.
WARNINGS SECTION
Warnings
OTC - ASK DOCTOR SECTION
Ask a doctor before use in children under 3 years of age.
OTC - STOP USE SECTION
Stop use and ask a doctor if symptoms persist for more than 3 days or worsen.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breastfeeding, ask a doctor before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
DOSAGE & ADMINISTRATION SECTION
Directions
- For best results, use at the first sign of symptoms and continue to use as needed.
- 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
THE Genexa PLEDGE
WE PLEDGE TO DELIVER THE HIGHEST QUALITY MEDICINES.
All our medicines are made of pure, clean, Certified Organic and Non-GMO Ingredients, carefully sourced and rigorously managed.
Genexa medicines are regulated by the FDA as drugs. We maintain the highest standards in manufacturing.
We pioneered the organic technology that eliminates harmful synthetics from our proprietary chewable tablet. A first of its kind!
Our chewable medicines are free of lactose, gluten, artificial preservatives, flavorings and colors.
© 2016 Distributed by:
Genexa LLC
Beverly Hills, CA 90212
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 EFFECTIVE and 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@genexahealth.com
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Children's
Genexa®
#1 ORGANIC MEDICINE
NDC 69676-0027-1
Ages 3+
NO DRUG INTERACTIONS
CALM KEEPER TM
ORGANIC 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 |
|---|---|
| 69676-0027 | 69676-0027-1 |
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 |
|---|---|---|---|---|---|---|
| 954864d4-abaf-34ea-e053-2a95a90a3525 | 4c6c2afd-17ad-2615-e054-00144ff8d46c | 2019-10-19 | Warnings | 954864d4-abaf-34ea-e053-2a95a90a3525 4c6c2afd-17ad-2615-e054-00144ff8d46c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.