FDA.reportPublic FDA data

Restulex

Manufacturer
HelloLife, Inc. | Apotheca Company
Effective date
2023-10-20
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 21:23:43

Label at a glance#

ProductRestulex
Active ingredientBUFO BUFO CUTANEOUS GLAND, CAUSTICUM, MATRICARIA CHAMOMILLA, CROTALUS HORRIDUS HORRIDUS VENOM, DIGITALIS, LACHESIS MUTA VENOM, LILIUM LANCIFOLIUM WHOLE FLOWERING, ANEMONE PRATENSIS, TOXICODENDRON PUBESCENS LEAF, SULFUR, LYCOSA TARANTULA, VISCUM ALBUM FRUIT, ZINC
Label structure10 sections

Dosage and administration

Dissolve under tongue. 30-50lb (13.6kg-22.6kg): twice daily. 50lb+ (22.6kg): 1 tablet twice daily.

Storage and handling

Do not store next to electrical devices or appliances. Keep lid tightly closed & store in a cool, dry place.

Label contents#

Full prescribing information#

ACTIVE HPUS INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Bufo Rana 10X, 30X, 200C, Causticum 10X, 30X, 200C, Chamomilla 10X, 30X, 200C, Crotalus Horridus 10X, 30X, 200C, Digitalis Purpurea 10X, 30X, 200C, Lachesis Mutus 10X, 30X, 200C, Lilium Tigrinum 10X, 30X, 200C, Pulsatilla (Pratensis) 10X, 30X, 200C, Rhus Tox 10X, 30X, 200C, Sulphur 10X, 30X, 200C, Tarentula Hispana 10X, 30X, 200C, Viscum Album 10X, 30X, 200C, Zincum Metallicum 10X, 30X, 200C.

INDICATIONS FOR USE:

OTC - PURPOSE SECTION

For the temporary relief of symptoms such as:

• twitching 

• burning

• heaviness

• jerking

• cramping

• pain

Product indications are based solely on Homeopathic Materia Medica and have not been evaluated by the FDA.

WARNINGS:

WARNINGS SECTION

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

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

Do not use if tamper seal is broken.

STORAGE & HANDLING:

STORAGE AND HANDLING SECTION

Do not store next to electrical devices or appliances.

Keep lid tightly closed & store in a cool, dry place.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Dissolve under tongue.

30-50lb (13.6kg-22.6kg): twice daily.

50lb+ (22.6kg): 1 tablet twice daily.

INDICATIONS FOR USE:

INDICATIONS & USAGE SECTION

For the temporary relief of symptoms such as:

• twitching

• burning

• heaviness

• jerking

• cramping

• pain

Product indications are based solely on Homeopathic Materia Medica and have not been evaluated by the FDA.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Copovidone, Crospovidone, Lactose, Magnesium, Stearate, Mannitol, Microcrystalline, Cellulose, Silicon Dioxide, Sorbitol.

QUESTIONS:

OTC - QUESTIONS SECTION

Dist. by: HelloLife, Inc.

4635 40th St SE

Grand Rapids, MI 49512

www.hellolife.net

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 49726-047-60
RESTULEX
TABLETS
Natural Relief for 
Restless Leg Symptoms
Homeopathic (OTC) Medicine
60 Quick-dissolving Tablets

RestulexRestulex

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49726-04749726-047-60

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
COPOVIDONE K25-31D9C330MD8BIACT
CROSPOVIDONE2S7830E561IACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MAGNESIUM STEARATE70097M6I30IACT
MANNITOL3OWL53L36AIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SORBITOL506T60A25RIACT
BUFO BUFO CUTANEOUS GLANDQ59QU6N72QACTIB
CAUSTICUMDD5FO1WKFUACTIB
MATRICARIA CHAMOMILLAG0R4UBI2ZZACTIB
CROTALUS HORRIDUS HORRIDUS VENOMYHA2XLJ956ACTIB
DIGITALISF1T8QT9U8BACTIB
LACHESIS MUTA VENOMVSW71SS07IACTIB
LILIUM LANCIFOLIUM WHOLE FLOWERINGX67Z2963PIACTIB
ANEMONE PRATENSIS8E272251DIACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
SULFUR70FD1KFU70ACTIB
LYCOSA TARANTULA86M454L2TTACTIB
VISCUM ALBUM FRUITP83EQ521R3ACTIB
ZINCJ41CSQ7QDSACTIB

Source Document#

Source XML

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
28db7a49-f386-8350-e063-6294a90af6da8ca44ca1-cd97-422f-a1dd-6fc0534ca1472024-12-09WarningsExact identifier
spl set id: 8ca44ca1-cd97-422f-a1dd-6fc0534ca147

Reported adverse events (FAERS/openFDA)#

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