Label: LEG CRAMPS- cinchona officinalis bark, aconitum napellus, pseudognaphalium obtusifolium, ledum palustre twig, magnesium phosphate, dibasic trihydrate, toxicodendron pubescens leaf and viscum album fruiting top tablet, soluble 

  • Label RSS
  • NDC Code(s): 54973-2956-1, 54973-2956-2, 54973-2956-3
  • Packager: Hyland's
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 04/13

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active Ingredients Purpose
    Cinchona Off. 3X HPUS pains in limbs & joints
    Aconitum Nap. 6X HPUS pains in joints, legs
    Gnaphalium Poly. 3X HPUS cramps in calves & feet
    Ledum Pal. 6X HPUS pain and cramps in legs
    Magnesia Phos. 6X HPUS cramps in calves
    Rhus Tox. 6X HPUS pain and stiffness
    Viscum Alb. 3X HPUS pains in joints
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  • Uses

    Temporarily relieves the symptoms of cramps and pains in lower back and legs.

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  • Warnings

    As with any drug, ask a doctor before use if

    • you are pregnant or nursing a baby
    • sensitive to quinine
    • under 12 years of age.

    Keep this and all medications out of the reach of children.

    Do not use if imprinted tamper band is broken or missing.

    In case of accidental overdose, contact a poison control center immediately.

    If symptoms persist for more than 7 days or worsen, discontinue use and seek the advice of a licensed healthcare professional.

    In case of emergency, Hyland's may be contacted 24 hours a day, 7 days a week at 800/624-9659.

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  • Directions

    Adults and children ages 12 and over

    Dissolve 2-3 tablets under tongue every 4 hours or as needed.

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  • Inactive Ingredients

    Lactose N.F.

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  • PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Carton

    NDC 54973-2956-02

    HOMEOPATHIC

    SINCE 1903

    100%
    Natural

    Stop the Pain!

    Hyland's®
    Leg
    Cramps

    Relax Calf & Foot Cramps

    100
    QUICK-DISSOLVING
    TABLETS

    PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Carton
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  • INGREDIENTS AND APPEARANCE
    LEG CRAMPS 
    cinchona officinalis bark, aconitum napellus, pseudognaphalium obtusifolium, ledum palustre twig, magnesium phosphate, dibasic trihydrate, toxicodendron pubescens leaf, and viscum album fruiting top tablet, soluble
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:54973-2956
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CINCHONA OFFICINALIS BARK (CINCHONA OFFICINALIS BARK) CINCHONA OFFICINALIS BARK 3 [hp_X]
    ACONITUM NAPELLUS (ACONITUM NAPELLUS) ACONITUM NAPELLUS 6 [hp_X]
    PSEUDOGNAPHALIUM OBTUSIFOLIUM (PSEUDOGNAPHALIUM OBTUSIFOLIUM) PSEUDOGNAPHALIUM OBTUSIFOLIUM 3 [hp_X]
    LEDUM PALUSTRE TWIG (LEDUM PALUSTRE TWIG) LEDUM PALUSTRE TWIG 6 [hp_X]
    MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (MAGNESIUM CATION) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 6 [hp_X]
    TOXICODENDRON PUBESCENS LEAF (TOXICODENDRON PUBESCENS LEAF) TOXICODENDRON PUBESCENS LEAF 6 [hp_X]
    VISCUM ALBUM FRUITING TOP (VISCUM ALBUM FRUITING TOP) VISCUM ALBUM FRUITING TOP 3 [hp_X]
    Inactive Ingredients
    Ingredient Name Strength
    LACTOSE  
    Product Characteristics
    Color WHITE Score no score
    Shape ROUND Size 9mm
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54973-2956-1 1 in 1 CARTON
    1 50 in 1 BOTTLE, PLASTIC
    2 NDC:54973-2956-3 4 in 1 POUCH
    3 NDC:54973-2956-2 1 in 1 CARTON
    3 100 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED HOMEOPATHIC 12/04/1995
    Labeler - Hyland's (028570695)
    Establishment
    Name Address ID/FEI Business Operations
    Standard Homeopathic Company 008316655 MANUFACTURE(54973-2956)
    Establishment
    Name Address ID/FEI Business Operations
    Merical, Inc. 029644978 MANUFACTURE(54973-2956)
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