Label: 4 KIDS PAIN RELIEF GRAPE- aconitum napellus, toxicodendron pubescens leaf, anemone pulsatilla, gelsemium sempervirens root, arnica montana, eupatorium perfoliatum flowering top, bryonia alba root and phosphorus liquid

  • NDC Code(s): 54973-4018-1, 54973-4018-2, 54973-4018-3
  • 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 23, 2022

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  • Drug Facts

    Active ingredients

    Aconitum Napellus 30X HPUS

    Arnica Montana 30X HPUS

    Bryonia Alba 30X HPUS

    Eupatorium Perfoliatum 30X HPUS

    Gelsemium Sempervirens 12X HPUS

    Phosphorus 12X HPUS

    Pulsatilla 9X HPUS

    Rhus Toxicodendron 12X HPUS

    "HPUS" indicates that the active ingredients are in the

    official Homeopathic Pharmacopoeia of the United States.

    Purpose

    headache, back pain,minor pain in joints

    muscle aches, pain

    back pain, minor pain in joints

    pain in back and limbs

    muscle aches/pain, headache

    minor pain in joints, headache

    toothache, minor pain in joints

    stiffness, minor pain in joints, cramps

  • Uses

    • Temporarily relieves minor pain symptoms in children, including:
    • muscle aches 
    • toothache 
    • headache
    • cramps 
    • stiffness 
    • back pain
    • pain in joints or limbs
  • Warnings

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

    Do not use more than directed.

    Consult a physician if:

    • symptoms persist for more than 48 hours or worsen.
    • inflammation, fever or infection develops.
    • symptoms are accompanied by a high fever (over 101°F).

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

    In case of emergency or accidental overdose, 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

    • Shake well before using.
    • Measure only with the dosing cup provided.
    • Do not use dosing cup with other products.
    • On dosing cup, mL = milliliter.

    Children 2 years

    to under 6 years

    5 mL every 15 minutes for

    4 doses, then every 4 hours until relieved.

    Children 6 years

    to under 12 years

    10 mL every 15 minutes for

    4 doses, then every 4 hours until relieved.

    Adults and children

    12 years and over

    15 mL every 15 minutes for

    4 doses, then every 4 hours until relieved.

  • Drug Facts (continued)

    Other information

    • Do not use if imprinted "SEALED FOR YOUR PROTECTION" tamper-evident bottle cap band is broken or missing.
    • The inner packaged bottle is child-resistant.
    • Store at room temperature.
    • Do not refrigerate.
  • Inactive ingredients

    Citric Acid, Glycerine, Glycyrrhiza Extract, Natural Grape Flavor, Purified Water, Sodium Benzoate.

  • Questions or comments?

    (800) 624-9659

  • SPL UNCLASSIFIED SECTION

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

  • Principal Display Panel - 118 mL Bottle Carton

    HOMEOPATHIC

    NDC 54973-4018-1

    2-12

    YEARS

    NEW

    4 KIDS

    SINCE 1903

    Hyland's

    Pain

    Relief*

    Relieves muscle aches,

    headache, minor joint

    pain and toothache

    NO ACETAMINOPHEN

    NO ALCOHOL or PARABENS

    NO SUGAR or DYES

    NATURAL

    RELIEF

    NATURAL

    GRAPE

    FLAVOR

    4 FL. OZ. (118 mL)

    *SEE NOTE

    ON SIDE PANEL

    BELOW DRUG FACTS

    Carton

  • INGREDIENTS AND APPEARANCE
    4 KIDS PAIN RELIEF GRAPE 
    aconitum napellus, toxicodendron pubescens leaf, anemone pulsatilla, gelsemium sempervirens root, arnica montana, eupatorium perfoliatum flowering top, bryonia alba root and phosphorus liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-4018
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS12 [hp_X]  in 1 mL
    ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA9 [hp_X]  in 1 mL
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF12 [hp_X]  in 1 mL
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA30 [hp_X]  in 1 mL
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT30 [hp_X]  in 1 mL
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS30 [hp_X]  in 1 mL
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT12 [hp_X]  in 1 mL
    EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E) EUPATORIUM PERFOLIATUM FLOWERING TOP30 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-4018-11 in 1 CARTON01/27/2020
    1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:54973-4018-25 mL in 1 PACKET; Type 0: Not a Combination Product01/27/202012/16/2021
    3NDC:54973-4018-31 in 1 CARTON01/27/2020
    3148 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/27/2020
    Labeler - Hyland's Inc. (008316655)
    Establishment
    NameAddressID/FEIBusiness Operations
    Applied Laboratories Inc.117337220manufacture(54973-4018) , pack(54973-4018) , label(54973-4018)
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