Restulex
FDA Label NDC 49726-022

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Hello Life, Inc. for the product Restulex (NDC 49726-022). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients (per dose), purpose, uses, warnings, otc - when using, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.

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

Uses

to temporarily relieve symptoms commonly associated with restless legs, such as: 
•    twitching       
•    jerking
•    burning
•    cramping
•    heaviness
•    pain

Warnings

Ask a doctor before use if

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

Otc - When Using

When using this product, use only as directed.

Otc - Stop Use

Stop use and ask a doctor if symptoms persist or worsen.

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

Keep out of the reach of children.

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

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


Principal Display Panel:

NDC 49726-022-02

RESTULEXTM

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

Restulexcarton (Restulexcarton)

Restulexcarton (Restulexcarton)

* Please review the disclaimer below.