Drug Facts

Drug Facts
SPL v11
SPL
SPL Set ID 10da19a2-8897-40ec-82ef-b8e925a5dd90
Routes
ORAL TOPICAL
Published
Effective Date 2016-01-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arsenic Cation (3+) (10 [hp_X]) Bufo Bufo Cutaneous Gland Causticum Matricaria Recutita Crotalus Horridus Horridus Venom Digitalis Lachesis Muta Venom Lilium Lancifolium Flowering Top Pulsatilla Vulgaris Toxicodendron Pubescens Leaf Sulfur Lycosa Tarantula Viscum Album Fruiting Top Zinc
Inactive Ingredients
Water Citric Acid Monohydrate Potassium Sorbate

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2011-11-09

Description

Arsenicum album HPUS Bufo rana HPUS Causticum HPUS Chamomilla HPUS Crotalus horridus HPUS Digitalis purpurea HPUS Lachesis mutus HPUS Lilium tigrinum HPUS Pulsatilla HPUS Rhus toxicodendron HPUS Sulphur HPUS Tarentula hispana HPUS Viscum album HPUS Zincum metallicum HPUS Each active ingredient contains equal volumes of 10X, 30X, and LM1 potencies. The letters “HPUS” indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States. Product indications are based on Homeopathic Materia Medica.

Purpose

Arsenicum album HPUS..............................Twitching Bufo rana HPUS...........................................Numbness of limbs Causticum HPUS..........................................Pain Chamomilla HPUS.......................................Rheumatic pains Crotalus horridus HPUS..............................Cannot keep legs or feet still Digitalis purpurea HPUS..............................Rheumatic pains Lachesis mutus HPUS..................................Restlessness Lilium tigrinum HPUS..................................Burning of feet Pulsatilla HPUS............................................Jerking Rhus toxicodendron HPUS..........................Tingling in feet Sulphur HPUS..............................................Stiffness Tarentula hispana HPUS..............................Extraordinary movements Viscum album HPUS....................................Muscle tremors Zincum metallicum HPUS............................Trembling


Medication Information

Purpose
Arsenicum album HPUS..............................Twitching

Bufo rana HPUS...........................................Numbness of limbs

Causticum HPUS..........................................Pain

Chamomilla HPUS.......................................Rheumatic pains

Crotalus horridus HPUS..............................Cannot keep legs or feet still

Digitalis purpurea HPUS..............................Rheumatic pains

Lachesis mutus HPUS..................................Restlessness

Lilium tigrinum HPUS..................................Burning of feet

Pulsatilla HPUS............................................Jerking

Rhus toxicodendron HPUS..........................Tingling in feet

Sulphur HPUS..............................................Stiffness

Tarentula hispana HPUS..............................Extraordinary movements

Viscum album HPUS....................................Muscle tremors

Zincum metallicum HPUS............................Trembling


Description
  • 30-day supply
  • dropper included
  • Restulex is made without alcohol or sugar.  No gluten added.

Mftd for: HelloLife, LLC.

4460 44th St SE, Ste. C-600

Grand Rapids, MI 49512

FDA Pharmaceutical Establishment

#1053442, #3009727070

www.restulex.com



Uses
to temporarily relieve symptoms commonly associated with restless legs, such as: 

•    twitching       

•    jerking

•    burning

•    cramping

•    heaviness

•    pain


Section 50565-1

Keep out of the reach of children.

Section 50566-9

Stop use and ask a doc tor if symptoms persist or worsen.

Section 50567-7

When using this product, use only as directed.

Section 53414-9

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

Warnings

Ask a doctor before use if

  • you are taking any other medications
  • you have a medical condition

Directions

Dispense Restulex directly into mouth, or add recommended dosage into 8-12 oz of purified (non-chlorinated) water and drink. Safe for ages 2 and up.

DOSAGE BY WEIGHT

30-50 lbs (13.6-22.6 kg)  1/2 mL twice per day

50+ lbs (22.6+ kg) 1 mL twice per day

External Use: If needed, apply to affected areas 2-6 times daily until symptoms improve.

Other Information


  • do not use if tamper seal is broken
  • store in a cool, dry place
  • product must not come in contact with metal
  • do not store next to electrical devices or appliances

Inactive Ingredients
citric acid, potassium sorbate, purified ionized mineral water




Questions Or Comments?

You can email us at [email protected] or call us toll-free at 1.800.875.0850 Monday through Friday 9am-5pm ET

Principal Display Panel:

NDC 49726-022-02



RESTULEX TM



Restless Leg Symptom Relief



To temporarily relieve symptoms commonly associated with restless legs, such as:



•    twitching       

•    burning

•    heaviness

•    jerking

•    cramping

•    pain



2 fl oz (59 mL)



Homeopathic (OTC) Medicine

Active Ingredients (per Dose)
Arsenicum album HPUS

Bufo rana HPUS

Causticum HPUS

Chamomilla HPUS

Crotalus horridus HPUS

Digitalis purpurea HPUS

Lachesis mutus HPUS

Lilium tigrinum HPUS

Pulsatilla HPUS

Rhus toxicodendron HPUS

Sulphur HPUS

Tarentula hispana HPUS

Viscum album HPUS

Zincum metallicum HPUS



Each active ingredient contains equal volumes of 10X, 30X, and LM1 potencies. The letters “HPUS” indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States. Product indications are based on Homeopathic Materia Medica.


Structured Label Content

Uses
to temporarily relieve symptoms commonly associated with restless legs, such as: 

•    twitching       

•    jerking

•    burning

•    cramping

•    heaviness

•    pain


Description (34089-3)
  • 30-day supply
  • dropper included
  • Restulex is made without alcohol or sugar.  No gluten added.

Mftd for: HelloLife, LLC.

4460 44th St SE, Ste. C-600

Grand Rapids, MI 49512

FDA Pharmaceutical Establishment

#1053442, #3009727070

www.restulex.com



Section 50565-1 (50565-1)

Keep out of the reach of children.

Section 50566-9 (50566-9)

Stop use and ask a doc tor if symptoms persist or worsen.

Section 50567-7 (50567-7)

When using this product, use only as directed.

Section 53414-9 (53414-9)

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

Purpose
Arsenicum album HPUS..............................Twitching

Bufo rana HPUS...........................................Numbness of limbs

Causticum HPUS..........................................Pain

Chamomilla HPUS.......................................Rheumatic pains

Crotalus horridus HPUS..............................Cannot keep legs or feet still

Digitalis purpurea HPUS..............................Rheumatic pains

Lachesis mutus HPUS..................................Restlessness

Lilium tigrinum HPUS..................................Burning of feet

Pulsatilla HPUS............................................Jerking

Rhus toxicodendron HPUS..........................Tingling in feet

Sulphur HPUS..............................................Stiffness

Tarentula hispana HPUS..............................Extraordinary movements

Viscum album HPUS....................................Muscle tremors

Zincum metallicum HPUS............................Trembling


Warnings

Ask a doctor before use if

  • you are taking any other medications
  • you have a medical condition

Directions

Dispense Restulex directly into mouth, or add recommended dosage into 8-12 oz of purified (non-chlorinated) water and drink. Safe for ages 2 and up.

DOSAGE BY WEIGHT

30-50 lbs (13.6-22.6 kg)  1/2 mL twice per day

50+ lbs (22.6+ kg) 1 mL twice per day

External Use: If needed, apply to affected areas 2-6 times daily until symptoms improve.

Other Information (Other information)


  • do not use if tamper seal is broken
  • store in a cool, dry place
  • product must not come in contact with metal
  • do not store next to electrical devices or appliances

Inactive Ingredients (Inactive ingredients)
citric acid, potassium sorbate, purified ionized mineral water




Questions Or Comments? (Questions or comments?)

You can email us at [email protected] or call us toll-free at 1.800.875.0850 Monday through Friday 9am-5pm ET

Principal Display Panel:

NDC 49726-022-02



RESTULEX TM



Restless Leg Symptom Relief



To temporarily relieve symptoms commonly associated with restless legs, such as:



•    twitching       

•    burning

•    heaviness

•    jerking

•    cramping

•    pain



2 fl oz (59 mL)



Homeopathic (OTC) Medicine

Active Ingredients (per Dose) (Active Ingredients (per dose))
Arsenicum album HPUS

Bufo rana HPUS

Causticum HPUS

Chamomilla HPUS

Crotalus horridus HPUS

Digitalis purpurea HPUS

Lachesis mutus HPUS

Lilium tigrinum HPUS

Pulsatilla HPUS

Rhus toxicodendron HPUS

Sulphur HPUS

Tarentula hispana HPUS

Viscum album HPUS

Zincum metallicum HPUS



Each active ingredient contains equal volumes of 10X, 30X, and LM1 potencies. The letters “HPUS” indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States. Product indications are based on Homeopathic Materia Medica.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)