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 LLC. 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 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

PURPOSE

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

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

Warnings

ASK DOCTOR

Ask a doctor before use in children under 3 years of age.

STOP USE

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

PREGNANCY OR BREAST FEEDING

If pregnant or breastfeeding, ask a doctor before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

DOSAGE & ADMINISTRATION

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

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

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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

www.genexahealth.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 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

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

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: 69676-0027
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	6 [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	6 [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: 69676-0027-1	1 in 1 CARTON	11/14/2016	04/30/2020
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		11/14/2016	04/30/2020

Labeler - Genexa LLC (079751024)