Search by Drug Name or NDC

NDC 69676-0008-01 Calm Keeper 12; 12; 6; 3; 8; 12; 8; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 Details

Calm Keeper 12; 12; 6; 3; 8; 12; 8; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1

Calm Keeper is a ORAL TABLET, CHEWABLE in the HUMAN OTC DRUG category. It is labeled and distributed by Genexa Inc.. The primary component is ACONITUM NAPELLUS; GELSEMIUM SEMPERVIRENS ROOT; MATRICARIA CHAMOMILLA WHOLE; PASSIFLORA INCARNATA FLOWERING TOP; POTASSIUM CARBONATE; STRYCHNOS IGNATII SEED; TRIBASIC CALCIUM PHOSPHATE; VALERIAN.

Product Information

NDC	69676-0008
Product ID	69676-0008_ba5e496b-e03f-b06a-e053-2995a90a9fa8
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Calm Keeper
Proprietary Name Suffix	n/a
Non-Proprietary Name	Aconitum napellus, Calcarea phosphorica, Chamomilla, Gelsemium sepervirens, Ignatia amara, Kali carbonicum, Passiflora incarnata, Valeriana officinalis
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, CHEWABLE
Route	ORAL
Active Ingredient Strength	12; 12; 6; 3; 8; 12; 8; 3
Active Ingredient Units	[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1
Substance Name	ACONITUM NAPELLUS; GELSEMIUM SEMPERVIRENS ROOT; MATRICARIA CHAMOMILLA WHOLE; PASSIFLORA INCARNATA FLOWERING TOP; POTASSIUM CARBONATE; STRYCHNOS IGNATII SEED; TRIBASIC CALCIUM PHOSPHATE; VALERIAN
Labeler Name	Genexa Inc.
Pharmaceutical Class	Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE]
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	n/a

Package

Package Images

NDC 69676-0008-01 (69676000801)

Pricing Information	N/A
NDC Package Code	69676-0008-1
Billing NDC	69676000801
Package	1 BOTTLE, PLASTIC in 1 CARTON (69676-0008-1) / 60 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC
Marketing Start Date	2018-07-20
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 7900262d-90fd-6c08-e053-2991aa0a77f9 Details

SPL UNCLASSIFIED SECTION

KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION

Drug Facts

SPL UNCLASSIFIED 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.

SPL UNCLASSIFIED 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

SPL UNCLASSIFIED SECTION

Uses*

addresses the following symptoms:

irritability
restlessness
oversensitivity
sleeplessness
nervousness

SPL UNCLASSIFIED SECTION

Warnings

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

Keep out of reach of children.

SPL UNCLASSIFIED 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

SPL UNCLASSIFIED SECTION

Other information

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

SPL UNCLASSIFIED 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

www.genexa.com

Certified Organic by SCS Global Services

SPL UNCLASSIFIED SECTION

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

[email protected]

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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]

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69676-0008-1	1 in 1 CARTON	07/20/2018	08/01/2023
1		60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		07/20/2018	08/01/2023

Labeler - Genexa Inc. (079751024)

Revised: 2/2021

Document Id: ba5e496b-e03f-b06a-e053-2995a90a9fa8

Set id: 7900262d-90fd-6c08-e053-2991aa0a77f9

Version: 6

Effective Time: 20210202

Search by Drug Name or NDC

NDC 69676-0008-01 Calm Keeper 12; 12; 6; 3; 8; 12; 8; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 Details

Calm Keeper 12; 12; 6; 3; 8; 12; 8; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1

Product Information

Package

Package Images

NDC 69676-0008-01 (69676000801)

Contents

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PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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