LEG CRAMPS - SWELLING - micrurus corallinus venom, silver nitrate, bryonia alba root, oyster shell calcium carbonate, crude, citrullus colocynthis fruit pulp, convallaria majalis, crotalus horridus horridus venom, copper, digitalis, gelsemium sempervirens root, hypericum perforatum, potassium carbonate, lachesis muta venom, lathyrus sativas seed, lilium lancifolium whole flowering, magnesium phosphate, dibasic trihydrate, strychnos nux-vomica seed, toxicodendron pubescens leaf, silicon dioxide, datura stramonium, veratrum viride root and echinacea, unspecified liquid
Newton Laboratories, Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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INDICATIONS & USAGE SECTION

Leg Cramps - Swelling Formulated for associated symptoms such as pain, cramping, swelling due to inflammation, stiffness and numbness in the legs and feet.

DOSAGE & ADMINISTRATION SECTION

Directions: ORAL USE ONLY - SHAKE WELL. Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) as needed or as directed by a healthcare professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Elaps corallinus 30x, Arg. nit. 15x, Bryonia 15x, Calc. carb. 15x, Colocynthis 15x, Convallaria 15x, Crotalus horridus 15x, Cuprum met. 15x, Digitalis 15x, Gelsemium 15x, Hypericum 15x, Kali carb. 15x, Lachesis 15x, Lathyrus sativus 15x, Lilium 15x, Mag. phos. 15x, Nux vom. 15x, Rhus toxicodendron 15x, Silicea 15x, Stramonium 15x, Veratrum viride 15x, Echinacea 3x.

OTC - PURPOSE SECTION

Formulated for associated symptoms such as pain, cramping, swelling due to inflammation, stiffness and numbness in the legs and feet.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane dispensing alcohol 20%.

QUESTIONS SECTION

www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions? 1.800.448.7256

WARNINGS SECTION

Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.

OTC - PREGNANCY OR BREAST FEEDING SECTION

Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

LEG CRAMPS - SWELLING
elaps corallinus, arg. nit., bryonia, calc. carb., colocynthis, convallaria, crotalus horridus, cuprum met., digitalis, gelsemium, hypericum, kali carb., lachesis, lathyrus sativus, lilium, mag. phos., nux vom., rhus toxicodendron, silicea, stramonium, veratrum viride, echinacea liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55714-2294
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Micrurus Corallinus Venom (Micrurus Corallinus Venom)	Micrurus Corallinus Venom	30 [hp_X] in 1 mL
Silver Nitrate (Silver Cation)	Silver Nitrate	15 [hp_X] in 1 mL
Bryonia Alba Root (Bryonia Alba Root)	Bryonia Alba Root	15 [hp_X] in 1 mL
Oyster Shell Calcium Carbonate, Crude (Oyster Shell Calcium Carbonate, Crude)	Oyster Shell Calcium Carbonate, Crude	15 [hp_X] in 1 mL
Citrullus Colocynthis Fruit Pulp (Citrullus Colocynthis Fruit Pulp)	Citrullus Colocynthis Fruit Pulp	15 [hp_X] in 1 mL
Convallaria Majalis (Convallaria Majalis)	Convallaria Majalis	15 [hp_X] in 1 mL
Crotalus Horridus Horridus Venom (Crotalus Horridus Horridus Venom)	Crotalus Horridus Horridus Venom	15 [hp_X] in 1 mL
Copper (Copper)	Copper	15 [hp_X] in 1 mL
Digitalis (Digitalis)	Digitalis	15 [hp_X] in 1 mL
Gelsemium Sempervirens Root (Gelsemium Sempervirens Root)	Gelsemium Sempervirens Root	15 [hp_X] in 1 mL
Hypericum Perforatum (Hypericum Perforatum)	Hypericum Perforatum	15 [hp_X] in 1 mL
Potassium Carbonate (Carbonate Ion)	Potassium Carbonate	15 [hp_X] in 1 mL
Lachesis Muta Venom (Lachesis Muta Venom)	Lachesis Muta Venom	15 [hp_X] in 1 mL
Lathyrus Sativas Seed (Lathyrus Sativas Seed)	Lathyrus Sativas Seed	15 [hp_X] in 1 mL
Lilium Lancifolium Whole Flowering (Lilium Lancifolium Whole Flowering)	Lilium Lancifolium Whole Flowering	15 [hp_X] in 1 mL
Magnesium Phosphate, Dibasic Trihydrate (Magnesium Cation)	Magnesium Phosphate, Dibasic Trihydrate	15 [hp_X] in 1 mL
Strychnos Nux-vomica Seed (Strychnos Nux-vomica Seed)	Strychnos Nux-vomica Seed	15 [hp_X] in 1 mL
Toxicodendron Pubescens Leaf (Toxicodendron Pubescens Leaf)	Toxicodendron Pubescens Leaf	15 [hp_X] in 1 mL
Silicon Dioxide (Silicon Dioxide)	Silicon Dioxide	15 [hp_X] in 1 mL
Datura Stramonium (Datura Stramonium)	Datura Stramonium	15 [hp_X] in 1 mL
Veratrum Viride Root (Veratrum Viride Root)	Veratrum Viride Root	15 [hp_X] in 1 mL
Echinacea, Unspecified (Echinacea, Unspecified)	Echinacea, Unspecified	3 [hp_X] in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Alcohol

Packaging
#	Item Code	Package Description
1	NDC:55714-2294-1	29.57 mL in 1 BOTTLE, GLASS
2	NDC:55714-2294-2	59.14 mL in 1 BOTTLE, GLASS
3	NDC:55714-2294-0	.5 mL in 1 BOTTLE, GLASS

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		03/01/2012

Labeler - Newton Laboratories, Inc. (788793610)

Registrant - Newton Laboratories, Inc. (788793610)

Establishment
Name	Address	ID/FEI	Business Operations
Newton Laboratories, Inc.		788793610	MANUFACTURE(55714-2294), API MANUFACTURE(55714-2294)

Revised: 03/2011

Document Id: 8591b533-d38d-37d4-9f77-27f73274df74

Set id: 8486896f-f74f-513d-a5d7-37522cc5e5a9

Version: 1

Effective Time: 20110301

Newton Laboratories, Inc.