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

Calm Keeper by

Drug Labeling and Warnings

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

Drug Details [pdf]

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KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION

Drug Facts

ACTIVE INGREDIENT

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.

PURPOSE

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

Uses*

addresses the following symptoms:

• irritability
• restlessness
• oversensitivity
• sleeplessness
• nervousness

WARNINGS

Warnings

STOP USE

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

KEEP OUT OF REACH OF CHILDREN

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 15-30° C (59-86° F) in a dry place out of direct sunlight

INACTIVE INGREDIENT

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

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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

www.genexa.com

Certified Organic by SCS Global Services

OTHER SAFETY INFORMATION

BOTTLE IS SAFETY SEALED.

DO NOT USE IF BOTTLE SEAL IS DISTURBED OR MISSING.

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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

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

INGREDIENTS AND APPEARANCE

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: 69676-0008
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: 69676-0008-1	1 in 1 CARTON	07/20/2018
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		07/20/2018

Labeler - Genexa Inc. (079751024)