Label: 4 KIDS LEG PAIN RELIEF- tribasic calcium phosphate, arnica montana, oyster shell calcium carbonate, crude, copper, eupatorium perfoliatum flowering top, magnesium phosphate, dibasic trihydrate, phosphorus, guaiacum officinale resin and phosphoric acid tablet

  • NDC Code(s): 54973-3383-1, 54973-3383-2
  • Packager: Hyland's
  • 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 June 24, 2019

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

  • Drug Facts

    Active ingredients

    Arnica Montana 30X HPUS

    Calcarea Carbonica 12X HPUS

    Calcarea Phosphorica 12X HPUS

    Cuprum Metallicum 12X HPUS

    Eupatorium Perfoliatum 30X HPUS

    Guaiacum 12X HPUS

    Magnesia Phosphorica 12X HPUS

    Phosphoricum Acidum 12X HPUS

    Phosphorus 12X HPUS

    “HPUS” indicates that the active ingredients are in the official Homeopathic

    Pharmacopœia of the United States.

    Purpose

    Arnica Montana 30X HPUS ..............................muscle soreness, stiffness and pain

    Calcarea Carbonica 12X HPUS............................................cramps and pain in legs

    Calcarea Phosphorica 12X HPUS................. aching pain in limbs, cramps in calves

    Cuprum Metallicum 12X HPUS........................pain in legs and calves when resting

    Eupatorium Perfoliatum 30X HPUS ................... soreness of limbs, aching in limbs

    Guaiacum 12X HPUS ..............................................................muscle and joint pain

    Magnesia Phosphorica 12X HPUS ...................................pain and cramps in calves

    Phosphoricum Acidum 12X HPUS....pain in thighs, cramps in thighs, legs and feet

    Phosphorus 12X HPUS...............................cramps in legs, knees extending to feet

  • Uses

    Temporarily relieves the symptoms of: • minor leg pain • muscle soreness and stiffness • aching pain and soreness in limbs • pain and cramps in calves, joints, thighs, knees and feet

  • Warnings

    As with any drug, ask doctor before use if pregnant or breast-feeding.

    Do not use

    • more than directed. • if you have a known allergy to any ingredient in this product.

    Consult a physician

    if symptoms persist for more than 7 days or worsen.

    Keep this and all medications out of reach of children

    In case of accidental overdose, contact a medical professional or Poison Control Center immediately.

    Do not use if imprinted tamper-evident bottle cap band is broken or missing

    The inner packaged bottle is child-resistant. In case of emergency, contact a medical professional or Poison Control Center immediately. Hyland’s may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.

  • Directions

    Children 2 years

    to under 6 years

    Dissolve 2 tablets under tongue every 15 minutes for up

    to 4 doses until relieved, then every 6 hours as required.

    Children 6 years

    to under 12 years

    Dissolve 3 tablets under tongue every 15 minutes for up

    to 4 doses until relieved, then every 6 hours as required.

    Adults and children

    12 years and over

    Dissolve 4 tablets under tongue every 15 minutes, for up

    to 4 doses until relieved, then every 6 hours as required.

  • Inactive ingredients

    Acacia Gum,Lactose.

  • Questions or comments?

    (800) 624-9659

  • Principal Display Panel - 50 Tablet Bottle Carton

    New!

    NDC 54973-3383-1

    HOMEOPATHIC

    NATURAL

    RELIEF

    Ages

    2-12

    SINCE 1903

    Hyland's

    4 Kids

    Leg Pain Relief*

    Muscle Aches

    & Soreness

    Pain & Stiffnes

    Leg Cramps

    50 QUICK-DISSOLVING TABLETS

    ACTUAL SIZE 194 MG

    Carton

    SIZE 194 MG

  • INGREDIENTS AND APPEARANCE
    4 KIDS LEG PAIN RELIEF 
    tribasic calcium phosphate, arnica montana, oyster shell calcium carbonate, crude, copper, eupatorium perfoliatum flowering top, magnesium phosphate, dibasic trihydrate, phosphorus, guaiacum officinale resin and phosphoric acid tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3383
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (PHOSPHATE ION - UNII:NK08V8K8HR) TRIBASIC CALCIUM PHOSPHATE12 [hp_X]
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA30 [hp_X]
    OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE12 [hp_X]
    COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5) COPPER12 [hp_X]
    EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E) EUPATORIUM PERFOLIATUM FLOWERING TOP30 [hp_X]
    GUAIACUM OFFICINALE RESIN (UNII: N0K2Z502R6) (GUAIACUM OFFICINALE RESIN - UNII:N0K2Z502R6) GUAIACUM OFFICINALE RESIN12 [hp_X]
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS12 [hp_X]
    MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE12 [hp_X]
    PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN) PHOSPHORIC ACID12 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    ACACIA (UNII: 5C5403N26O)  
    Product Characteristics
    Colorwhite (White to Off White) Scoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-3383-11 in 1 CARTON11/01/2018
    150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:54973-3383-26 in 1 PACKET; Type 0: Not a Combination Product11/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/01/2018
    Labeler - Hyland's (028570695)
    Establishment
    NameAddressID/FEIBusiness Operations
    Standard Homeopathic Company008316655manufacture(54973-3383) , pack(54973-3383) , label(54973-3383)