Search by Drug Name or NDC

NDC 69676-0007-01 Stress Relief 12; 12; 12; 8; 3; 12; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 Details

Stress Relief 12; 12; 12; 8; 3; 12; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1

Stress Relief 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; LYCOPODIUM CLAVATUM SPORE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PASSIFLORA INCARNATA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; VALERIAN.

Product Information

NDC	69676-0007
Product ID	69676-0007_b86b6bd0-5877-85af-e053-2995a90adac2
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	Stress Relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	Aconitum napellus, Calcarea carbonica, Gelsemium sempervirens, Lycopodium clavatum, Nux vomica, Passiflora incarnata, Valeriana officinalis
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, CHEWABLE
Route	ORAL
Active Ingredient Strength	12; 12; 12; 8; 3; 12; 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
Substance Name	ACONITUM NAPELLUS; GELSEMIUM SEMPERVIRENS ROOT; LYCOPODIUM CLAVATUM SPORE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PASSIFLORA INCARNATA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; VALERIAN
Labeler Name	Genexa Inc.
Pharmaceutical Class	Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	n/a

Package

Package Images

NDC 69676-0007-01 (69676000701)

Pricing Information	N/A
NDC Package Code	69676-0007-1
Billing NDC	69676000701
Package	1 BOTTLE, PLASTIC in 1 CARTON (69676-0007-1) / 60 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC
Marketing Start Date	2018-07-03
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 78ffdb9a-b800-818f-e053-2a91aa0aaff7 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 carbonica 8X HPUS

Gelsemium sempervirens ‡ 12X HPUS

Lycopodium clavatum ‡ 12X HPUS

Nux vomica ‡ 12X 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

fatigue and restlessness

irritability and anticipatory anxiety

apprehensiveness and inability to think clearly

restless sleep and stress

nervousness & digestive symptoms due to stress

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Uses*

address symptoms associated with stress, such as:

fatigue
nervousness
anxiousness
irritability
hypersensitivity

SPL UNCLASSIFIED SECTION

Warnings

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

SPL UNCLASSIFIED SECTION

If pregnant or breastfeeding, ask a health professional before use.

SPL UNCLASSIFIED SECTION

Keep out of reach of children.

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Directions

Adults and children 12 years of age and older	chew 2 tablets at the onset of symptoms do not swallow whole repeat every 8 hours as needed
Children 3-11 years of age	chew 1 tablet at the onset of symptoms do not swallow whole repeat every 8 hours as needed
Children under 3 years of age	ask a doctor before use

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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 FDA EVALUATED.

** X is a homeopathic dilution: see www.genexa.com for more information.

Patent Pending

SPL UNCLASSIFIED SECTION

THE Genexa® PLEDGE

WE PLEDGE TO DELIVER THE HIGHEST QUALITY MEDICINES.

All our products are made of clean, certified organic and non-GMO ingredients.

Genexa medicines 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

Genexa®

THE HEALTHIER MEDICINE®

NDC 69676-0007-1

NON-HABIT FORMING

STRESS RELIEF TM

ORGANIC STRESS & FATIGUE FORMULA*

Anxiety & Irritabilty*
Sleeplessness*
Fatigue*

60 CHEWABLE TABLETS

HOMEOPATHIC

VANILLA LAVENDER FLAVOR

USDA ORGANIC

NON GMO Project VERIFIED

INGREDIENTS AND APPEARANCE

STRESS RELIEF

aconitum napellus, calcarea carbonica, gelsemium sempervirens, lycopodium clavatum, nux vomica, passiflora incarnata, valeriana officinalis tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69676-0007
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	12 [hp_X]
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW)	VALERIAN	3 [hp_X]
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	12 [hp_X]
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I)	OYSTER SHELL CALCIUM CARBONATE, CRUDE	8 [hp_X]
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	12 [hp_X]
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O)	PASSIFLORA INCARNATA FLOWERING TOP	3 [hp_X]
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q)	GELSEMIUM SEMPERVIRENS ROOT	12 [hp_X]

Ingredient Name	Strength
Inactive Ingredients
MALTODEXTRIN (UNII: 7CVR7L4A2D)
DEXTROSE (UNII: IY9XDZ35W2)
RICE BRAN (UNII: R60QEP13IC)
CARNAUBA WAX (UNII: R12CBM0EIZ)

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:69676-0007-1	1 in 1 CARTON	07/03/2018	07/31/2023
1		60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC:69676-0007-3	2 in 1 POUCH; Type 0: Not a Combination Product	07/03/2018	09/30/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		07/03/2018	07/31/2023

Labeler - Genexa Inc. (079751024)

Revised: 1/2021

Document Id: b86b6bd0-5877-85af-e053-2995a90adac2

Set id: 78ffdb9a-b800-818f-e053-2a91aa0aaff7

Version: 5

Effective Time: 20210108

Search by Drug Name or NDC

NDC 69676-0007-01 Stress Relief 12; 12; 12; 8; 3; 12; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 Details

Stress Relief 12; 12; 12; 8; 3; 12; 3 [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 69676-0007-01 (69676000701)

Contents

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PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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