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NDC 69676-0047-01 Genexa Jet Lag 12; 6; 6; 12; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 Details

Genexa Jet Lag 12; 6; 6; 12; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1

Genexa Jet Lag is a ORAL TABLET, CHEWABLE in the HUMAN OTC DRUG category. It is labeled and distributed by Genexa Inc.. The primary component is ANAMIRTA COCCULUS SEED; ARABICA COFFEE BEAN; ARNICA MONTANA; CINCHONA OFFICINALIS BARK; TOBACCO LEAF.

Product Information

NDC	69676-0047
Product ID	69676-0047_de2013bd-d72d-3294-e053-2a95a90a069d
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	Genexa Jet Lag
Proprietary Name Suffix	n/a
Non-Proprietary Name	Arnica montana, Cinchona officinalis, Cocculus indicus, Coffea cruda, Tabacum
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, CHEWABLE
Route	ORAL
Active Ingredient Strength	12; 6; 6; 12; 6
Active Ingredient Units	[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1
Substance Name	ANAMIRTA COCCULUS SEED; ARABICA COFFEE BEAN; ARNICA MONTANA; CINCHONA OFFICINALIS BARK; TOBACCO LEAF
Labeler Name	Genexa Inc.
Pharmaceutical Class	Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [E
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 69676-0047-01 (69676004701)

Pricing Information	N/A
NDC Package Code	69676-0047-1
Billing NDC	69676004701
Package	1 BOTTLE, PLASTIC in 1 CARTON (69676-0047-1) / 60 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC
Marketing Start Date	2021-11-04
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d1262318-0a97-bf90-e053-2995a90a16a7 Details

SPL UNCLASSIFIED SECTION

Keep outer package for complete product information

Drug Facts

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Active ingredients ‡**

Arnica montana 6X HPUS

Cinchona officinalis 12X HPUS

Cocculus indicus 12X HPUS

Coffea cruda 6X HPUS

Tabacum 6X HPUS

‡ Organic

"HPUS" indicates that this ingredient is officially included in the Homeopathic Pharmacopoeia of the United States.

SPL UNCLASSIFIED SECTION

Purpose

fatigue, irritability and lethargy

mood changes, fatigue and early waking

excessive sleepiness, loss of appetite & constipation

headache, lightheadedness & inability to concentrate

sleeplessness, nausea and anxiety

SPL UNCLASSIFIED SECTION

Uses*

addresses symptoms associated with jet lag.

SPL UNCLASSIFIED SECTION

Warnings

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

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

Keep out of reach of children.

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Directions

adults and children 12 years of age and older	chew 2 tablets on each takeoff, 2 approximately every 4 hours, and 2 after landing intervals of up to 5 hours between tablets are acceptable if sleeping do not swallow whole.
children 3-11 years of age	chew 1 tablet on each takeoff, 1 approximately every 4 hours, and 1 after landing intervals of up to 5 hours between tablets are acceptable if sleeping do not swallow whole
children under 3 years of age	ask a doctor before use.

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Other information

store between 20-25°C (68-77°F) in a dry place out of direct sunlight

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Inactive ingredients

organic carnauba wax, organic dextrose, organic maltodextrin, organic rice bran extract, vanilla lavender flavor

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Questions?

1-855-436-3921

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* CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT EVALUATED BY THE FOOD AND DRUG ADMINISTRATION.

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

SPL UNCLASSIFIED SECTION

Bottle is safety sealed with a perforated band around bottle. DO NOT use if bottle seal is disturbed or missing.

Patent Pending | Distributed by:

Genexa Inc. Atlanta, GA 30318

genexa.com

Certified Organic by SCS Global Services

SPL UNCLASSIFIED SECTION

Made in the USA with globally sourced ingredients

R-20220209

NDC 69676-0047-1

PRINCIPAL DISPLAY PANEL

Genexa®

Jet Lag

Jet Lag Prevention Formula*

Sufficient for 60 Hours of Flying

Feel Awake & Alert*

Feel Refreshed*

Know your ingredients

Made without: common allergens, artifical dyes or parabens

Homeopathic

60 Chewable Tablets

Vanilla Lavender Flavor

INGREDIENTS AND APPEARANCE

GENEXA JET LAG

arnica montana, cinchona officinalis, cocculus indicus, coffea cruda, tabacum tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69676-0047
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ANAMIRTA COCCULUS SEED (UNII: 810258W28U) (ANAMIRTA COCCULUS SEED - UNII:810258W28U)	ANAMIRTA COCCULUS SEED	12 [hp_X]
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72)	ARABICA COFFEE BEAN	6 [hp_X]
TOBACCO LEAF (UNII: 6YR2608RSU) (TOBACCO LEAF - UNII:6YR2608RSU)	TOBACCO LEAF	6 [hp_X]
CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB)	CINCHONA OFFICINALIS BARK	12 [hp_X]
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	6 [hp_X]

Ingredient Name	Strength
Inactive Ingredients
MALTODEXTRIN (UNII: 7CVR7L4A2D)
RICE BRAN (UNII: R60QEP13IC)
CARNAUBA WAX (UNII: R12CBM0EIZ)
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
Packaging
1	NDC:69676-0047-1	1 in 1 CARTON	11/04/2021
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		11/04/2021

Labeler - Genexa Inc. (079751024)

Revised: 5/2022

Document Id: de2013bd-d72d-3294-e053-2a95a90a069d

Set id: d1262318-0a97-bf90-e053-2995a90a16a7

Version: 2

Effective Time: 20220503

Search by Drug Name or NDC

NDC 69676-0047-01 Genexa Jet Lag 12; 6; 6; 12; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 Details

Genexa Jet Lag 12; 6; 6; 12; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1

Product Information

Package

Package Images

NDC 69676-0047-01 (69676004701)

Contents

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PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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