Label: 4 KIDS SORE THROAT GRAPE- spongia officinalis skeleton, roasted, aconitum napellus, phosphorus, calcium sulfide and ferrosoferric phosphate liquid

  • 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 15X HPUS

    Ferrum Phosphoricum 12X HPUS

    Hepar Sulphuris Calcareum 12X HPUS

    Phosphorus 9X HPUS

    Spongia Tosta 12X HPUS

    HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.

    Purpose

    sore throat

    sore throat

    sore throat

    pain in throat

    sore throat

  • Uses

    • Temporarily relieves sore throat symptoms in children, including:
    • occasional minor irritation 
    • pain
  • 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 7 days 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.

    Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea and vomiting may be serious. Consult a doctor promptly.

    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 up to 6 times per day (every 4 hours).

    Children 6 years

    to under 12 years

    10 mL up to 6 times per day (every 4 hours).

    Adults and children

    12 years and over

    15 mL up to 6 times per day (every 4 hours).

  • 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 54973-4020-1

    2-12

    YEARS

    NEW

    4 KIDS

    SINCE 1903

    Hyland's

    Sore

    Throat*

    Relieves minor

    sore throat pain

    and irritation

    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 SORE THROAT GRAPE 
    spongia officinalis skeleton, roasted, aconitum napellus, phosphorus, calcium sulfide and ferrosoferric phosphate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-4020
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE12 [hp_X]  in 1 mL
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS9 [hp_X]  in 1 mL
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS15 [hp_X]  in 1 mL
    SPONGIA OFFICINALIS SKELETON, ROASTED (UNII: 1PIP394IID) (SPONGIA OFFICINALIS SKELETON, ROASTED - UNII:1PIP394IID) SPONGIA OFFICINALIS SKELETON, ROASTED12 [hp_X]  in 1 mL
    FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7) FERROSOFERRIC PHOSPHATE12 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-4020-11 in 1 CARTON02/14/2020
    1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/14/2020
    Labeler - Hyland's Inc. (008316655)
    Establishment
    NameAddressID/FEIBusiness Operations
    Applied Laboratories, Inc.117337220manufacture(54973-4020) , pack(54973-4020) , label(54973-4020)
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