Restulex

Manufacturer
Hello Life, Inc. | King Bio Inc.
Effective date
2018-12-26
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-06-01 02:10:37

Label at a glance#

ProductRestulex Restless Leg Symptom Relief
Active ingredientARSENIC TRIOXIDE, 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
Label structure12 sections

Indications and uses

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

Dosage and administration

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.

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredients (per dose)

OTC - ACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

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

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Ask a doctor before use if

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

OTC - WHEN USING SECTION

When using this product, use only as directed.

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION


  • 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 INGREDIENT SECTION

citric acid, potassium sorbate, purified ionized mineral water


Questions or comments?

OTC - QUESTIONS SECTION

You can email us at info@hellolife.net or call us toll-free at 1.800.875.0850 Monday through Friday 9am-5pm ET

DESCRIPTION SECTION

  • 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:

PACKAGE LABEL.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

RestulexCartonRestulexCarton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49726-022-022020-01-31C16284748780-19d75b9d0-cc1c-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49726-022-02RestulexRestless Leg Symptom Relief59 mL in 1 BOTTLE, DROPPERLIQUID5911
49726-022-02RestulexRestless Leg Symptom Relief1 in 1 CARTONLIQUID111

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49726-022RESTULEX RESTLESS LEG SYMPTOM RELIEF (ARSENICUM ALBUM, BUFO RANA, CAUSTICUM, CHAMOMILLA, CROTALUS HORRIDUS, DIGITALIS PURPUREA, LACHESIS MUTUS, LILIUM TIGRINUM, PULSATILLA, RHUS TOXICODENDRON, SULPHUR, TARENTULA HISPANA, VISCUM ALBUM, ZINCUM METALLICUM) LIQUID [HELLO LIFE, INC.]11Legacy NDC, 2 package rows20181227_10da19a2-8897-40ec-82ef-b8e925a5dd90.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ARSENIC TRIOXIDEACTIVE INGREDIENTS7V92P67HO9
BUFO BUFO CUTANEOUS GLANDACTIVE INGREDIENTQ59QU6N72Q9
CAUSTICUMACTIVE INGREDIENTDD5FO1WKFU9
CROTALUS HORRIDUS HORRIDUS VENOMACTIVE INGREDIENTYHA2XLJ9569
DIGITALISACTIVE INGREDIENTF1T8QT9U8B9
LACHESIS MUTA VENOMACTIVE INGREDIENTVSW71SS07I9
LILIUM LANCIFOLIUM FLOWERING TOPACTIVE INGREDIENT6268MFA9179
LYCOSA TARANTULAACTIVE INGREDIENT86M454L2TT9
MATRICARIA RECUTITAACTIVE INGREDIENTG0R4UBI2ZZ9
PULSATILLA VULGARISACTIVE INGREDIENTI76KB35JEV9
SULFURACTIVE INGREDIENT70FD1KFU709
TOXICODENDRON PUBESCENS LEAFACTIVE INGREDIENT6IO182RP7A9
VISCUM ALBUM FRUITING TOPACTIVE INGREDIENTBK9092J5MP9
ZINCACTIVE INGREDIENTJ41CSQ7QDS9
ARSENIC CATION (3+)ACTIVE MOIETYC96613F5AV9
BUFO BUFO CUTANEOUS GLANDACTIVE MOIETYQ59QU6N72Q9
CAUSTICUMACTIVE MOIETYDD5FO1WKFU9
CROTALUS HORRIDUS HORRIDUS VENOMACTIVE MOIETYYHA2XLJ9569
DIGITALISACTIVE MOIETYF1T8QT9U8B9
LACHESIS MUTA VENOMACTIVE MOIETYVSW71SS07I9
LILIUM LANCIFOLIUM FLOWERING TOPACTIVE MOIETY6268MFA9179
LYCOSA TARANTULAACTIVE MOIETY86M454L2TT9
MATRICARIA RECUTITAACTIVE MOIETYG0R4UBI2ZZ9
PULSATILLA VULGARISACTIVE MOIETYI76KB35JEV9
SULFURACTIVE MOIETY70FD1KFU709
TOXICODENDRON PUBESCENS LEAFACTIVE MOIETY6IO182RP7A9
VISCUM ALBUM FRUITING TOPACTIVE MOIETYBK9092J5MP9
ZINCACTIVE MOIETYJ41CSQ7QDS9
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP9
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ49
WATERINACTIVE INGREDIENT059QF0KO0R9

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49726-02249726-022-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 107 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SOLUTION / SUBCUTANEOUS26 mgExact identifier — unii candidate
88 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4SUSPENSION / ORAL400 mgExact identifier — unii candidate
19 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / SUBCUTANEOUS28 mgExact identifier — unii candidate
88 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4TABLET, EXTENDED RELEASE / ORAL0.2 mgExact identifier — unii candidate
19 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPLIQUID / INTRAVENOUS0.2 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPCREAM / VAGINAL0.49 %w/wExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRAMUSCULAR28 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPTABLET, EFFERVESCENT / ORAL460 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPTABLET, FILM COATED / ORAL42 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSUSPENSION / ORAL269 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRAVENOUS2068 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPTABLET, ORALLY DISINTEGRATING / ORAL83 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / TOPICAL17 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPPOWDER, FOR SOLUTION / TOPICALNAExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SOLUTION, CONCENTRATE / INTRAOCULAR1 mgExact identifier — unii candidate
88 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4GRANULE, FOR SUSPENSION / ORAL80 mgExact identifier — unii candidate
19 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / ORAL446 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL2 mgExact identifier — unii candidate
88 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4AEROSOL, FOAM / TOPICAL8 mgExact identifier — unii candidate
19 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPGRANULE, FOR SUSPENSION / ORAL113 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / INTRAVENOUS10 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / BUCCALNAExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRALESIONALADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSUSPENSION/ DROPS / ORAL19 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPTABLET, CHEWABLE / ORAL7 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SOLUTION / INTRA-ARTICULARADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPFILM, EXTENDED RELEASE / TRANSDERMAL1.38 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSPRAY, METERED / NASAL2 mgExact identifier — unii candidate
88 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4SPRAY, METERED / NASAL0.06 mgExact identifier — unii candidate
19 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPDOUCHE / VAGINAL0.07 %w/wExact identifier — unii candidate
88 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4CAPSULE / ORALNAExact identifier — unii candidate
19 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS385 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / PERIDURALNAExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SOLUTION / INTRAMUSCULAR26 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSUSPENSION, EXTENDED RELEASE / ORAL140.8 mgExact identifier — unii candidate
88 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4CREAM / TOPICAL0.25 %w/wExact identifier — unii candidate
19 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPCONCENTRATE / ORAL5.3 mg/1mlExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INFILTRATION0.02 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPTABLET, COATED / ORALNAExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPPOWDER / ORAL840 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSUSPENSION / RESPIRATORY (INHALATION)0.03 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION/ DROPS / AURICULAR (OTIC)0.04 %w/wExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / IONTOPHORESIS0.02 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPLIQUID / RESPIRATORY (INHALATION)0.13 %w/wExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPCREAM / TOPICAL4 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRAPLEURALADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4POWDER, FOR SUSPENSION / ORAL19 mgExact identifier — unii candidate
19 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPOINTMENT / TOPICAL1 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / SOFT TISSUEADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOAP / TOPICAL0.5 %w/wExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPPOWDER, FOR SUSPENSION / ORAL840 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / NASAL2.8 mg/1mlExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSYSTEM / IONTOPHORESIS0.2 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRASYNOVIALADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRATHECALADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / INTRAMUSCULAR0.05 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4TABLET, COATED / ORALNAExact identifier — unii candidate
19 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4EMULSION / OPHTHALMIC0.47 %w/vExact identifier — unii candidate
19 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSYSTEM / TOPICAL0.2 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINHALANT / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
88 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
7df183c1-5f52-1a16-e053-2991aa0a222310da19a2-8897-40ec-82ef-b8e925a5dd902018-12-26WarningsExact identifier
spl id: 7df183c1-5f52-1a16-e053-2991aa0a2223
spl set id: 10da19a2-8897-40ec-82ef-b8e925a5dd90

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.