Label: RESTFUL LEGS- arsenic trioxide, lycopodium clavatum spore, pulsatilla vulgaris, toxicodendron pubescens leaf, sulfur, and zinc tablet, soluble

  • NDC Code(s): 54973-3162-1, 54973-3162-2
  • Packager: Hyland's Inc.
  • 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 November 7, 2022

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  • PURPOSE

    Temporarily relieves occasional symptoms of: agitation or compelling urge to jerk or move legs, creeping, crawling, itching, twitching or tingling sensation in legs.

  • Drug Facts

    Active ingredients

    Active ingredientsPurpose

    Arsenicum Album 12X HPUS

    (0.000000000076% Arsenic, calculated)

    		creeping, crawling itch
    Lycopodium 6X HPUSfeeling of agitation while lying down
    Pulsatilla 6X HPUSconstant urge to move legs
    Rhus Toxicodendron 6X HPUSagitation, better with activity
    Sulphur 6X HPUSitching, tingling and urge to move legs
    Zincum Metallicum 12X HPUStwitching and jerking of legs while sitting

    "HPUS" is the Homeopathic Pharmacopoeia of the United States.

  • Uses

    ■ Helps temporarily relieves occasional symptoms of:

    ■ agitation or compelling urge to jerk or move legs

    ■ itching, tingling, or crawling sensations in the legs

  • Directions

    ■ Use as directed.

    Adults and children
    12 years and over     		At onset of symptoms, dissolve 2-3 tablets
    under tongue every 4 hours until relieved.
    Children 6 years
    to under 12 years     		At onset of symptoms, dissolve 1-2 tablets
    under tongue every 4 hours until relieved.

  • Warnings

    Ask a doctor before use if you have

    Restless Leg Syndrome.

    Stop use and ask a doctor if

    symptoms persist for more than 7 days or worsen.

    If pregnant or breastfeeding

    Ask a health professional before use.

    Keep out of reach of children.

  • Inactive Ingredients

    Acacia Gum, Lactose.

  • Questions?

    www.hylands.com or care@hylands.com

  • *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

  • **THIS PRODUCT IS NOT INTENDED TO TREAT RESTLESS LEG SYNDROME.

  • DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING

  • PRINCIPAL DISPLAY PANEL

    Hyland's

    NATURALS™

    RESTFUL

    LEGS

    FAST + EFFECTIVE RELIEF*

    Calms agitated

    legs so you

    can rest**

    50

    QUICK-DISSOLVING

    TABLETS

    HOMEOPATHIC

    Carton

  • INGREDIENTS AND APPEARANCE
    RESTFUL LEGS 
    arsenic trioxide, lycopodium clavatum spore, pulsatilla vulgaris, toxicodendron pubescens leaf, sulfur, and zinc tablet, soluble
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3162
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE12 [hp_X]
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE6 [hp_X]
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS6 [hp_X]
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF6 [hp_X]
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR6 [hp_X]
    ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC12 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE (UNII: J2B2A4N98G)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code NONE
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-3162-11 in 1 CARTON07/17/2006
    150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:54973-3162-24 in 1 PACKET; Type 0: Not a Combination Product07/17/2006
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/17/2006
    Labeler - Hyland's Inc. (008316655)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hyland's Inc.008316655manufacture(54973-3162) , pack(54973-3162) , label(54973-3162)
    Establishment
    NameAddressID/FEIBusiness Operations
    MeriCal, Inc.118445308manufacture(54973-3162)
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