Label: HYLANDS LEG CRAMPS WITH ARNICA- aconitum napellus tablet

  • NDC Code(s): 54973-4126-1, 54973-4126-2, 54973-4126-3
  • Packager: Hyland's Consumer Health 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 March 21, 2024

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  • Homeopathic claims

    *CLAIMS BASED ON TRADITIONAL HOMEOPATHICPRACTICE,

    NOT ACCEPTED MEDICAL EVIDENCE, NOT FDA EVALUATED.

  • DRUG FACTS

    Drug Facts

  • Active Ingredients

    ACONITUM NAPELLUS 5X HPUS

    ARNICA MONTANA 5X HPUS

    CINCHONA OFFICINALIS 2X HPUS

    GNAPHALIUM POLYCEPHALIUM 2X HPUS

    LEDUM PAULSTRE 5X HPUS

    MAGNESIA PHOSPHORICA 5X HPUS

    RHUS TOXICODENDRON 5X HPUS

    "HPUS" is the Homeopathic Pharmacopeia of the United States

  • Purpose*

    Pain in joints and legs

    Leg muscle soreness and pain

    Cramping in legs

    Cramps in calves and feet

    Pain and cramps in legs

    Muscle cramps

    Pain and stiffness

  • Uses*

    Helps temporarily relieve symptoms of:

    • Stiffness
    • Pain in joints or legs
    • Cramps in calves, feet or legs
    • Residuall muscle soreness
  • Directions

    Use as directed

    Adults and children 12 and over:

    At onset of symptoms, swallow 1-2 caplets with water every 4 hours as needed. If the initial dosage is not providing immediate relief, swallow 1-2 caplets with water every 30 minutes until relieved, up to 6 doses.

    Children under 12 years of age:

    Ask a doctor beofre use

  • Inactive ingredients

    Lactose, Magnesium Stearate, Microcrystalline Cellulose

  • Questions?

    www.hylands.com or care@hylands.com

  • DOSAGE & ADMINISTRATION

    Oral

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • WARNINGS

    ASK A DOCTOR BEFORE USE IF:

    SENSITIVE TO QUININE

    PREGNANT OR BREASTFEEDING

  • PRINCIPAL DISPLAY PANEL

    Leg Cramps with Arnica 100 countHylands Naturals

    Leg Cramps*

    +Arnica

    Helps relieve leg

    cramps and residual soreness

    100

    caplets

    [product image]

    Homeopathic

  • INGREDIENTS AND APPEARANCE
    HYLANDS LEG CRAMPS WITH ARNICA 
    aconitum napellus tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-4126
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS5 [hp_X]
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF5 [hp_X]
    CINCHONA BARK (UNII: 292E43P4I9) (CINCHONA BARK - UNII:292E43P4I9) CINCHONA BARK2 [hp_X]
    PSEUDOGNAPHALIUM OBTUSIFOLIUM (UNII: 36XQ854NWW) (PSEUDOGNAPHALIUM OBTUSIFOLIUM - UNII:36XQ854NWW) PSEUDOGNAPHALIUM OBTUSIFOLIUM2 [hp_X]
    LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) LEDUM PALUSTRE TWIG2 [hp_X]
    ARNICA MONTANA WHOLE (UNII: O80TY208ZW) (ARNICA MONTANA WHOLE - UNII:O80TY208ZW) ARNICA MONTANA WHOLE5 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize9mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-4126-1100 in 1 CARTON; Type 0: Not a Combination Product03/21/2024
    2NDC:54973-4126-240 in 1 CARTON; Type 0: Not a Combination Product03/21/2024
    3NDC:54973-4126-316 in 1 CARTON; Type 0: Not a Combination Product03/21/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/21/2024
    Labeler - Hyland's Consumer Health Inc. (008316655)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hyland's Consumer Health INC.008316655manufacture(54973-4126) , pack(54973-4126) , label(54973-4126)
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