Restless 2555p

Restless 2555p
SPL v2
SPL
SPL Set ID 9b3f076e-7edd-ea51-e053-2a95a90abd9b
Route
ORAL
Published
Effective Date 2019-08-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avicularia Avicularia (16 [hp_X]) Causticum (15 [hp_X]) Cinchona Officinalis Bark (6 [hp_X]) Conium Maculatum Flowering Top Copper Gelsemium Sempervirens Root Hyoscyamus Niger Hypericum Perforatum Carbonate Ion Mercury Amanita Muscaria Fruiting Body Strychnos Nux-vomica Seed Lead Toxicodendron Pubescens Leaf Claviceps Purpurea Sclerotium Strychnine Lycosa Tarantula Valerian Verbascum Thapsus Zinc Matricaria Chamomilla Passiflora Incarnata Flowering Top
Inactive Ingredients
Sucrose

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2019-08-01

Description

Formulated for associated symptoms such as the constant need to move the legs and feet, cramping, jerking, twitching and trembling.

Purpose

Formulated for associated symptoms such as the constant need to move the legs and feet, cramping, jerking, twitching and trembling.


Medication Information

Purpose

Formulated for associated symptoms such as the constant need to move the legs and feet, cramping, jerking, twitching and trembling.

Description

Formulated for associated symptoms such as the constant need to move the legs and feet, cramping, jerking, twitching and trembling.

Package Label

Warnings Section

WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.

Questions Section

newtonlabs.net – Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

Otc Purpose Section

Formulated for associated symptoms such as the constant need to move the legs and feet, cramping, jerking, twitching and trembling.

Inactive Ingredient Section

Inactive Ingredients: Gluten-free, non-GMO, organic beet-derived sucrose (lactose-free) pellets.

Indications & Usage Section

Formulated for associated symptoms such as the constant need to move the legs and feet, cramping, jerking, twitching and trembling.

Dosage & Administration Section

Directions: Ages 12 and up, take 6 pellets by mouth (ages 0 to 11, give 3 pellets) as needed or as directed by a health professional. Under age 2, crush/dissolve pellets in purified water. Sensitive persons being with 1 pellet and gradually increase to full dose.

Otc Active Ingredient Section

Equal parts of Chamomilla 6x, Passiflora incarnata 6x, Valeriana officinalis 6x, Agaricus muscarius 15x, Causticum 15x, Cinchona officinalis 15x, Conium maculatum 15x, Cuprum metallicum 15x, Gelsemium sempervirens 15x, Hyoscyamus niger 15x, Hypericum perforatum 15x, Kali carbonicum 15x, Magnesia carbonica 15x, Mercurius vivus 15x, Nux vomica 15x, Plumbum metallicum 15x, Rhus toxicodendron 15x, Secale cornutum 15x, Strychninum 15x, Tarentula hispana 15x, Valeriana officinalis 15x, Verbascum thapsus 15x, Zincum metallicum 15x, Mygale 16x.

Otc Pregnancy Or Breast Feeding Section

If pregnant or breast-feeding, ask a doctor before use.

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)

WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.

Questions Section (QUESTIONS SECTION)

newtonlabs.net – Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

Otc Purpose Section (OTC - PURPOSE SECTION)

Formulated for associated symptoms such as the constant need to move the legs and feet, cramping, jerking, twitching and trembling.

Inactive Ingredient Section (INACTIVE INGREDIENT SECTION)

Inactive Ingredients: Gluten-free, non-GMO, organic beet-derived sucrose (lactose-free) pellets.

Indications & Usage Section (INDICATIONS & USAGE SECTION)

Formulated for associated symptoms such as the constant need to move the legs and feet, cramping, jerking, twitching and trembling.

Dosage & Administration Section (DOSAGE & ADMINISTRATION SECTION)

Directions: Ages 12 and up, take 6 pellets by mouth (ages 0 to 11, give 3 pellets) as needed or as directed by a health professional. Under age 2, crush/dissolve pellets in purified water. Sensitive persons being with 1 pellet and gradually increase to full dose.

Otc Active Ingredient Section (OTC - ACTIVE INGREDIENT SECTION)

Equal parts of Chamomilla 6x, Passiflora incarnata 6x, Valeriana officinalis 6x, Agaricus muscarius 15x, Causticum 15x, Cinchona officinalis 15x, Conium maculatum 15x, Cuprum metallicum 15x, Gelsemium sempervirens 15x, Hyoscyamus niger 15x, Hypericum perforatum 15x, Kali carbonicum 15x, Magnesia carbonica 15x, Mercurius vivus 15x, Nux vomica 15x, Plumbum metallicum 15x, Rhus toxicodendron 15x, Secale cornutum 15x, Strychninum 15x, Tarentula hispana 15x, Valeriana officinalis 15x, Verbascum thapsus 15x, Zincum metallicum 15x, Mygale 16x.

Otc Pregnancy Or Breast Feeding Section (OTC - PREGNANCY OR BREAST FEEDING SECTION)

If pregnant or breast-feeding, ask a doctor before use.

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

All Sections (JSON)