Restless Leg description, usages, side effects, indications, overdosage, supplying and lots more!

Restless Leg

Newton Laboratories, Inc.
Newton Laboratories, Inc.

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Restless Leg

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

INDICATIONS & USAGE SECTION

Restless Leg    Formulated for symptoms associated with Restless Leg Syndrome, Parkinson's, neuroleptic~induced akathisia and other related conditions.

DOSAGE & ADMINISTRATION SECTION

Directions:  Ages 12 and up, take 6 pellets orally (ages 0 to 11, give 3 pellets) as needed or as directed by a healthcare professional.  Under age 2, crush or dissolve pellets in purified water.

ACTIVE INGREDIENT SECTION

Mygale 15x, Agaricus musc. 10x, Causticum 10x, Cinchona 10x, Conium 10x, Cuprum met. 10x, Gelsemium 10x, Hyoscyamus 10x, Hypericum 10x, Kali carb. 10x ,Mag. carb. 10x, Merc. viv. 10x, Nux vom. 10x, Plumb. met. 10x, Rhus toxicodendron 10x, Secale 10x, Strychninum 10x, Tarentula hispana 10x, Valeriana 10x, Verbascum 10x, Zinc. met. 10x, Chamomilla 3x, Passiflora 3x, Valeriana 3x.

PURPOSE SECTION

Formulated for symptoms associated with Restless Leg Syndrome, Parkinson's, neuroleptic-induced akathisia and other related conditions.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Gluten-free, non-GMO, beet-derived sucrose pellets.

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.

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. 

KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

PACKAGE LABEL

Restless Leg

Mygale, Agaricus musc., Causticum, Cinchona, Conium, Cuprum met., Gelsemium, Hyoscyamus, Hypericum, Kali carb, Mag.carb, Merc. viv., Nux vom., Plumb. met., Rhus toxicodendron, Secale, Strychninum, Tarentula hispana, Valeriana, Verbascum, Zinc. met., Chamomilla, Passiflora PELLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:55714-4613
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Avicularia Avicularia Avicularia Avicularia 15 [hp_X]
AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY AMANITA MUSCARIA VAR. MUSCARIA 10 [hp_X]
CAUSTICUM CAUSTICUM 10 [hp_X]
Cinchona Officinalis Bark Cinchona Officinalis Bark 10 [hp_X]
Conium Maculatum Flowering Top CONIUM MACULATUM FLOWERING TOP 10 [hp_X]
Copper COPPER 10 [hp_X]
GELSEMIUM SEMPERVIRENS ROOT GELSEMIUM SEMPERVIRENS ROOT 10 [hp_X]
Hyoscyamus Niger HYOSCYAMUS NIGER 10 [hp_X]
Hypericum Perforatum HYPERICUM PERFORATUM 10 [hp_X]
POTASSIUM CARBONATE CARBONATE ION 10 [hp_X]
MAGNESIUM CARBONATE 10 [hp_X]
MERCURY Mercury 10 [hp_X]
STRYCHNOS NUX-VOMICA SEED STRYCHNOS NUX-VOMICA SEED 10 [hp_X]
LEAD LEAD 10 [hp_X]
TOXICODENDRON PUBESCENS LEAF TOXICODENDRON PUBESCENS LEAF 10 [hp_X]
CLAVICEPS PURPUREA SCLEROTIUM CLAVICEPS PURPUREA SCLEROTIUM 10 [hp_X]
Strychnine Strychnine 10 [hp_X]
LYCOSA TARANTULA LYCOSA TARANTULA 10 [hp_X]
Valerian VALERIAN 10 [hp_X]
VERBASCUM THAPSUS VERBASCUM THAPSUS 10 [hp_X]
Zinc ZINC 10 [hp_X]
Matricaria Recutita MATRICARIA RECUTITA 3 [hp_X]
Passiflora Incarnata Flowering Top PASSIFLORA INCARNATA FLOWERING TOP 3 [hp_X]

Inactive Ingredients

Ingredient Name Strength
SUCROSE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55714-4613-1 28.35 in 1 BOTTLE, GLASS
2 NDC:55714-4613-2 56.7 in 1 BOTTLE, GLASS

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2011-06-01


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