Leg Cramps - swelling

Leg Cramps - swelling
SPL v2
SPL
SPL Set ID 8486896f-f74f-513d-a5d7-37522cc5e5a9
Route
ORAL
Published
Effective Date 2012-05-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Micrurus Corallinus Venom (30 [hp_X]) Silver Cation (15 [hp_X]) Bryonia Alba Root (3 [hp_X]) Oyster Shell Calcium Carbonate, Crude Citrullus Colocynthis Fruit Pulp Convallaria Majalis Crotalus Horridus Horridus Venom Copper Digitalis Gelsemium Sempervirens Root Hypericum Perforatum Carbonate Ion Lachesis Muta Venom Lathyrus Sativas Seed Lilium Lancifolium Whole Flowering Magnesium Cation Strychnos Nux-vomica Seed Toxicodendron Pubescens Leaf Silicon Dioxide Datura Stramonium Veratrum Viride Root Echinacea, Unspecified
Inactive Ingredients
Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2012-03-01

Description

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

Purpose

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


Medication Information

Purpose

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

Description

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

Package Label

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.  

Questions Section

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

Questions?  1.800.448.7256 

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%.  

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 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.


Structured Label Content

Package Label (PACKAGE LABEL)

Warnings Section (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.  

Questions Section (QUESTIONS SECTION)

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

Questions?  1.800.448.7256 

Otc Purpose Section (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 INGREDIENT SECTION)

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

Indications & Usage Section (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 (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 (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 Pregnancy Or Breast Feeding Section (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 (OTC - KEEP OUT OF REACH OF CHILDREN SECTION)

Keep out of reach of children.


Advanced Ingredient Data


Raw Label Data

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