Search by Drug Name or NDC

NDC 69676-0009-02 Leg Cramp Rx 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

Leg Cramp Rx 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

Leg Cramp Rx 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	69676-0009
Product ID	69676-0009_b013a412-1d04-6784-e053-2a95a90af42f
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	Leg Cramp Rx
Proprietary Name Suffix	n/a
Non-Proprietary Name	Angustura vera, Belladonna, Berberis vulgaris, 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	n/a

Package

Package Images

NDC 69676-0009-02 (69676000902)

Pricing Information	N/A
NDC Package Code	69676-0009-2
Billing NDC	69676000902
Package	1 BOTTLE, PLASTIC in 1 CARTON (69676-0009-2) / 100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC
Marketing Start Date	2018-10-24
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 7900701d-7275-11f3-e053-2991aa0a1130 Details

SPL UNCLASSIFIED SECTION

KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredients ‡*** (in each tablet)

Angustura vera 12X HPUS

Berberis vulgaris 6X HPUS

Chamomilla 6X HPUS

Colchicum autumnale 12X HPUS

Colocynthis 12X HPUS

Ignatia amara 12X HPUS

Jatropha curcus 12X HPUS

Lycopodium clavatum 6X HPUS

Nux moschata 6X HPUS

Rhus toxicodendron 12X HPUS

Secale cornutum 12X HPUS

Veratrum album 12X HPUS

‡ Certified Organic

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

SPL UNCLASSIFIED SECTION

Purpose

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

SPL UNCLASSIFIED SECTION

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.

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 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

SPL UNCLASSIFIED SECTION

THE Genexa® PLEDGE

WE PLEDGE TO DELIVER THE HIGHEST QUALITY PRODUCTS.

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 medicines are free of artificial dyes, flavors and preservatives.

Distributed by: Genexa Inc.

Los Angeles, CA 90034

www.genexa.com

Certified Organic by SCS Global Services

*THIS IS NOT A PRESCRIPTION MEDICINE

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 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

[email protected]

SPL UNCLASSIFIED SECTION

MADE IN THE USA WITH GLOBALLY SOURCED INGREDIENTS

R-20191204

PRINCIPAL DISPLAY PANEL

Genexa®

THE HEALTHIER MEDICINE®

NDC 69676-0009-2

LEG CRAMP Rx*

ORGANIC LEG CRAMP & PAIN FORMULA**

Calf & Foot Cramps**

Joint Pain & Stiffness**

Soreness & Swelling**

100 CHEWABLE TABLETS

HOMEOPATHIC

GRAPE FLAVOR

USDA ORGANIC

INGREDIENTS AND APPEARANCE

LEG CRAMP RX

angustura vera, belladonna, berberis vulgaris, 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:69676-0009
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	Marketing End Date
Packaging
1	NDC:69676-0009-2	1 in 1 CARTON	10/24/2018	06/30/2023
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		10/24/2018	06/30/2023

Labeler - Genexa Inc. (079751024)

Revised: 9/2020

Document Id: b013a412-1d04-6784-e053-2a95a90af42f

Set id: 7900701d-7275-11f3-e053-2991aa0a1130

Version: 4

Effective Time: 20200924

Search by Drug Name or NDC

NDC 69676-0009-02 Leg Cramp Rx 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

Leg Cramp Rx 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 69676-0009-02 (69676000902)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 7900701d-7275-11f3-e053-2991aa0a1130 Details

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PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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