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NDC 69676-0045-02 Genexa Leg Cramps 12; 6; 12; 12; 12; 12; 6; 6; 6; 12; 12; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [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

Genexa Leg Cramps 12; 6; 12; 12; 12; 12; 6; 6; 6; 12; 12; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1

Genexa Leg Cramps is a ORAL TABLET, CHEWABLE in the HUMAN OTC DRUG category. It is labeled and distributed by Genexa Inc.. The primary component is ANGOSTURA BARK; BERBERIS VULGARIS ROOT BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; CLAVICEPS PURPUREA SCLEROTIUM; COLCHICUM AUTUMNALE BULB; JATROPHA CURCAS SEED; LYCOPODIUM CLAVATUM SPORE; MATRICARIA CHAMOMILLA; NUTMEG; STRYCHNOS IGNATII SEED; TOXICODENDRON P.

Product Information

NDC	69676-0045
Product ID	69676-0045_e4914aab-4d72-4762-e053-2995a90a29f4
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 Leg Cramps
Proprietary Name Suffix	n/a
Non-Proprietary Name	Angustura vera, Berberis vulgaris, Chamomilla, Colchicum autumnale, Colocynthis, Ignatia amara, Jatropha curcas, Lycopodium clavatum, Nux moshchata, Rhus toxicodendron, Secale cornutum, Veratrum album
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, CHEWABLE
Route	ORAL
Active Ingredient Strength	12; 6; 12; 12; 12; 12; 6; 6; 6; 12; 12; 12
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; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1
Substance Name	ANGOSTURA BARK; BERBERIS VULGARIS ROOT BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; CLAVICEPS PURPUREA SCLEROTIUM; COLCHICUM AUTUMNALE BULB; JATROPHA CURCAS SEED; LYCOPODIUM CLAVATUM SPORE; MATRICARIA CHAMOMILLA; NUTMEG; STRYCHNOS IGNATII SEED; TOXICODENDRON P
Labeler Name	Genexa Inc.
Pharmaceutical Class	Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage P
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 69676-0045-02 (69676004502)

Pricing Information	N/A
NDC Package Code	69676-0045-2
Billing NDC	69676004502
Package	1 BOTTLE, PLASTIC in 1 CARTON (69676-0045-2) / 100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC
Marketing Start Date	2020-09-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b012df58-15fb-5c73-e053-2995a90a9d2b Details

SPL UNCLASSIFIED SECTION

Keep outer package for complete product information

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredients ‡**

Angustura vera 12X HPUS

Berberis vulgaris 6X HPUS

Chamomilla 6X HPUS

Colchicum autumnale 12X HPUS

Colocynthis 12X HPUS

Ignatia amara 12X HPUS

Jatropha curcas 12X HPUS

Lycopodium clavatum 6X HPUS

Nux moschata 6X HPUS

Rhus toxicodendron 12X HPUS

Secale cornutum 12X HPUS

Veratrum album 12X HPUS

‡ Organic

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

SPL UNCLASSIFIED SECTION

Purposes

cramps in legs

pain in calves and feet

cramps in calves and feet

pain in joints and legs

pain in legs

cramps in legs

stiffness

pain in joints and lower limbs

cramps in legs

swelling

soreness

cramps in feet, calves and legs

SPL UNCLASSIFIED SECTION

Uses*

addresses stiffness, pain in limbs, joints, and legs, and cramps in calves, feet and legs.

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.

SPL UNCLASSIFIED SECTION

Directions

adults and children 12 years of age and older	chew 2 tablets at the onset of symptoms do not swallow whole repeat every 4-6 hours as needed
children 3-11 years of age	chew 1 tablet at the onset of symptoms do not swallow whole repeat every 4-6 hours as needed
children under 3 years of age	ask a doctor before use

SPL UNCLASSIFIED SECTION

Other information

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

SPL UNCLASSIFIED SECTION

Inactive ingredients

organic carnauba wax, organic dextrose, grape flavor, organic maltodextrin, organic rice bran extract

SPL UNCLASSIFIED SECTION

Questions?

1-855-436-3921

SPL UNCLASSIFIED SECTION

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

** X is a homeopathic dilution; see 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-20220210

NDC 69676-0045-2

PRINCIPAL DISPLAY PANEL

Genexa®

Leg Cramps

Organic Leg Cramp & Pain Formula*

Calf & Foot Cramps*

Soreness & Swelling*

Joint Pain & Stiffness*

Know your ingredients

Made without: common allergens, artificial dyes, or parabens

Homeopathic

100 Chewable Tablets

Grape Flavor

INGREDIENTS AND APPEARANCE

GENEXA LEG CRAMPS

angustura vera, berberis vulgaris, chamomilla, colchicum autumnale, colocynthis, ignatia amara, jatropha curcas, lycopodium clavatum, nux moshchata, rhus toxicodendron, secale cornutum, veratrum album tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69676-0045
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ)	MATRICARIA CHAMOMILLA	6 [hp_X]
ANGOSTURA BARK (UNII: 104010O5VU) (ANGOSTURA BARK - UNII:104010O5VU)	ANGOSTURA BARK	12 [hp_X]
BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (BERBERIS VULGARIS ROOT BARK - UNII:1TH8Q20J0U)	BERBERIS VULGARIS ROOT BARK	6 [hp_X]
CITRULLUS COLOCYNTHIS FRUIT PULP (UNII: 23H32AOH17) (CITRULLUS COLOCYNTHIS FRUIT PULP - UNII:23H32AOH17)	CITRULLUS COLOCYNTHIS FRUIT PULP	12 [hp_X]
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K)	STRYCHNOS IGNATII SEED	12 [hp_X]
JATROPHA CURCAS SEED (UNII: J0F5GM8LA8) (JATROPHA CURCAS SEED - UNII:J0F5GM8LA8)	JATROPHA CURCAS SEED	12 [hp_X]
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	6 [hp_X]
NUTMEG (UNII: AEE24M3MQ9) (NUTMEG - UNII:AEE24M3MQ9)	NUTMEG	6 [hp_X]
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A)	TOXICODENDRON PUBESCENS LEAF	12 [hp_X]
CLAVICEPS PURPUREA SCLEROTIUM (UNII: 01G9XEA93N) (CLAVICEPS PURPUREA SCLEROTIUM - UNII:01G9XEA93N)	CLAVICEPS PURPUREA SCLEROTIUM	12 [hp_X]
VERATRUM ALBUM ROOT (UNII: QNS6W5US1Z) (VERATRUM ALBUM ROOT - UNII:QNS6W5US1Z)	VERATRUM ALBUM ROOT	12 [hp_X]
COLCHICUM AUTUMNALE BULB (UNII: 993QHL78E6) (COLCHICUM AUTUMNALE BULB - UNII:993QHL78E6)	COLCHICUM AUTUMNALE BULB	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	GRAPE	Imprint Code	G
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69676-0045-2	1 in 1 CARTON	09/15/2020
1		100 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		09/15/2020

Labeler - Genexa Inc. (079751024)

Revised: 7/2022

Document Id: e4914aab-4d72-4762-e053-2995a90a29f4

Set id: b012df58-15fb-5c73-e053-2995a90a9d2b

Version: 3

Effective Time: 20220724

Search by Drug Name or NDC

NDC 69676-0045-02 Genexa Leg Cramps 12; 6; 12; 12; 12; 12; 6; 6; 6; 12; 12; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [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

Genexa Leg Cramps 12; 6; 12; 12; 12; 12; 6; 6; 6; 12; 12; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [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 69676-0045-02 (69676004502)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL b012df58-15fb-5c73-e053-2995a90a9d2b Details

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PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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