Label: RESTFUL LEGS PM- anemone patens,matricaria chamomilla,sulfur,zinc,toxicodendron pubescens leaf,arsenic trioxide,arabica coffee bean,lycopodium clavatum spore tablet

  • NDC Code(s): 54973-3352-1, 54973-3352-2, 54973-3352-3, 54973-3352-4, view more
    54973-3352-5
  • 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 2, 2022

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  • Drug Facts

    Active Ingredients

    Arsenicum Album 12X HPUS

    Chamomilla 3X HPUS

    Coffea Cruda 3X HPUS

    Lycopodium 6X HPUS

    Pulsatilla 6X HPUS

    Rhus Toxicodendron 6X HPUS

    Sulphur 6X HPUS

    Zincum Metallicum 12X HPUS

    “HPUS” indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.

    Purpose

    creeping, crawling itch

    occasional sleeplessness, disrupted sleep

    occasional sleeplessness

    feeling of agitation while lying down

    constant urge to move legs

    agitation, better with activity

    itching, tingling, and urge to move legs

    twitching and jerking of legs while sitting

  • Uses

    ■ Helps temporarily relieve occasional sleeplessness or disrupted sleep due to:

    ■ agitation or compelling urge to jerk or move legs

    ■ itching, tingling, or crawling sensations in legs

  • 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

  • Directions

    ■ Use as directed.

    Adults and Children

    12 years and over

    Dissolve 2-3 tablets under tongue at bedtime and

    every 4 hours during the night until relieved.

    Children 6 years

    to under 12 years

    Dissolve 1-2 tablets under tongue at bedtime and

    every 4 hours during the night until relieved.

  • 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 PM

    FAST + EFFECTIVE RELIEF*

    Helps calm

    agitated legs

    so you can sleep**

    50

    QUICK-DISSOLVING

    TABLETS

    HOMEOPATHIC

    carton1

  • INGREDIENTS AND APPEARANCE
    RESTFUL LEGS PM 
    anemone patens,matricaria chamomilla,sulfur,zinc,toxicodendron pubescens leaf,arsenic trioxide,arabica coffee bean,lycopodium clavatum spore tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3352
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE12 [hp_X]
    MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA3 [hp_X]
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR6 [hp_X]
    ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC12 [hp_X]
    ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN3 [hp_X]
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE6 [hp_X]
    PULSATILLA PATENS WHOLE (UNII: 4M1169RWJD) (PULSATILLA PATENS WHOLE - UNII:4M1169RWJD) PULSATILLA PATENS WHOLE6 [hp_X]
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF6 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    ACACIA (UNII: 5C5403N26O)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    Product Characteristics
    Colorwhite (Off-White to Light Beige) Scoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-3352-11 in 1 CARTON03/14/2018
    150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:54973-3352-24 in 1 PACKET; Type 0: Not a Combination Product03/14/2018
    3NDC:54973-3352-31 in 1 CARTON03/14/201812/29/2021
    330 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    4NDC:54973-3352-41 in 1 CARTON03/14/2018
    416 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    5NDC:54973-3352-51 in 1 CARTON03/14/2018
    516 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/14/2018
    Labeler - Hyland's Inc. (008316655)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hyland's Consumer Health Inc.008316655pack(54973-3352) , label(54973-3352) , manufacture(54973-3352)
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