Label: RESTULEX (bufo rana, causticum, chamomilla, crotalus horridus, digitalis purpurea, lachesis mutus, lilium tigrinum, pulsatilla- pratensis rhus tox, sulphur, tarentula hispana, viscum album, zincum metallicum. tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated October 20, 2023

If you are a consumer or patient please visit this version.

View All Sections
  • ACTIVE HPUS INGREDIENTS:

    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:

    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:

    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:

    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:

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

  • DIRECTIONS:

    Dissolve under tongue.

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

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

  • INDICATIONS FOR USE:

    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:

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

  • QUESTIONS:

    Dist. by: HelloLife, Inc.

    4635 40th St SE

    Grand Rapids, MI 49512

    www.hellolife.net

  • PACKAGE LABEL DISPLAY:

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

    Restulex

  • INGREDIENTS AND APPEARANCE
    RESTULEX 
    bufo rana, causticum, chamomilla, crotalus horridus, digitalis purpurea, lachesis mutus, lilium tigrinum, pulsatilla (pratensis) rhus tox, sulphur, tarentula hispana, viscum album, zincum metallicum. tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49726-047
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BUFO BUFO CUTANEOUS GLAND (UNII: Q59QU6N72Q) (BUFO BUFO CUTANEOUS GLAND - UNII:Q59QU6N72Q) BUFO BUFO CUTANEOUS GLAND10 [hp_X]
    CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU) CAUSTICUM10 [hp_X]
    MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA10 [hp_X]
    CROTALUS HORRIDUS HORRIDUS VENOM (UNII: YHA2XLJ956) (CROTALUS HORRIDUS HORRIDUS VENOM - UNII:YHA2XLJ956) CROTALUS HORRIDUS HORRIDUS VENOM10 [hp_X]
    DIGITALIS (UNII: F1T8QT9U8B) (DIGITALIS - UNII:F1T8QT9U8B) DIGITALIS10 [hp_X]
    LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM10 [hp_X]
    LILIUM LANCIFOLIUM WHOLE FLOWERING (UNII: X67Z2963PI) (LILIUM LANCIFOLIUM WHOLE FLOWERING - UNII:X67Z2963PI) LILIUM LANCIFOLIUM WHOLE FLOWERING10 [hp_X]
    ANEMONE PRATENSIS (UNII: 8E272251DI) (ANEMONE PRATENSIS - UNII:8E272251DI) ANEMONE PRATENSIS10 [hp_X]
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF10 [hp_X]
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR10 [hp_X]
    LYCOSA TARANTULA (UNII: 86M454L2TT) (LYCOSA TARANTULA - UNII:86M454L2TT) LYCOSA TARANTULA10 [hp_X]
    VISCUM ALBUM FRUIT (UNII: P83EQ521R3) (VISCUM ALBUM FRUIT - UNII:P83EQ521R3) VISCUM ALBUM FRUIT10 [hp_X]
    ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC10 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    COPOVIDONE K25-31 (UNII: D9C330MD8B)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code H
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49726-047-6060 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/10/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/10/2019
    Labeler - HelloLife, Inc. (065619378)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(49726-047) , api manufacture(49726-047) , label(49726-047) , pack(49726-047)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!