Label: 4 KIDS COMPLETE ALLERGY DAYTIME- sodium chloride, aconitum napellus, luffa operculata fruit, euphrasia stricta,galphimia glauca flowering top, histamine dihydrochloride,onion,anemone pulsatilla and schoennocaulon officinale seed 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 22, 2022

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  • Drug Facts

    Active ingredients

    Aconitum Napellus 6X HPUS

    Allium Cepa 6X HPUS

    Euphrasia Officinalis 6X HPUS

    Galphimia Glauca 12X HPUS

    Histaminum Hydrochloricum 12X HPUS

    Luffa Operculata 12X HPUS

    Natrum Muriaticum 6X HPUS

    Pulsatilla 6X HPUS

    Sabadilla 6X HPUS

    “HPUS” indicates that the active ingredients are in the

    official Homeopathic Pharmacopœia of the United States.

    Purpose

    Aconitum Napellus 6X HPUS ....itchy throat, sneezing

    Allium Cepa 6X HPUS ..runny nose, watery/itchy eyes

    Euphrasia Officinalis 6X HPUS...........nasal discharge

    Galphimia Glauca 12X HPUS .... sneezing, runny nose

    Histaminum Hydrochloricum 12X HPUS ... itchy nose

    Luffa Operculata 12X HPUS .......sinus pain, headache

    Natrum Muriaticum 6X HPUS ....... itchy/burning eyes

    Pulsatilla 6X HPUS.............................. sinus pressure

    Sabadilla 6X HPUS ................. uncontrollable sneezing

  • Uses

    ■ Temporarily relieves symptoms of upper respiratory allergies in children, including:

    ■ runny nose  ■ sneezing

    ■ itchy or watery eyes  ■ itchy nose or throat

    ■ sinus pain or pressure ■ headache

  • Warnings

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

    Do not use

    ■ more than directed. ■ to treat food allergies.

    Consult a physician if symptoms persist for more than 7 days or worsen.

    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 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, Purified Water, Sodium Benzoate.

  • Questions or comments?

    (800) 624-9659

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

  • PRINCIPAL DISPLAY PANEL

    HOMEOPATHIC

    NDC 54973-3382-1

    2-12

    YEARS

    NEW

    LOOK

    4 KIDS

    SINCE 1903

    Hyland's

    DAYTIME

    Complete

    Allergy*

    Relieves runny nose,

    sneezing, itchy eyes

    & throat

    NO ALCOHOL or PARABENS

    NO SUGAR or DYES

    NATURAL

    RELIEF

    4 FL. OZ. (118 mL)

    *SEE NOTE

    ON SIDE PANEL

    BELOW DRUG FACTS

    carton

  • INGREDIENTS AND APPEARANCE
    4 KIDS COMPLETE ALLERGY DAYTIME 
    sodium chloride, aconitum napellus, luffa operculata fruit, euphrasia stricta,galphimia glauca flowering top, histamine dihydrochloride,onion,anemone pulsatilla and schoennocaulon officinale seed liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3382
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SCHOENOCAULON OFFICINALE SEED (UNII: 6NAF1689IO) (SCHOENOCAULON OFFICINALE SEED - UNII:6NAF1689IO) SCHOENOCAULON OFFICINALE SEED6 [hp_X]  in 1 mL
    ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION6 [hp_X]  in 1 mL
    ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA6 [hp_X]  in 1 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE6 [hp_X]  in 1 mL
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS6 [hp_X]  in 1 mL
    EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA6 [hp_X]  in 1 mL
    GALPHIMIA GLAUCA FLOWERING TOP (UNII: 93PH5Q8M7E) (GALPHIMIA GLAUCA FLOWERING TOP - UNII:93PH5Q8M7E) GALPHIMIA GLAUCA FLOWERING TOP12 [hp_X]  in 1 mL
    HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE12 [hp_X]  in 1 mL
    LUFFA OPERCULATA FRUIT (UNII: C4MO6809HU) (LUFFA OPERCULATA FRUIT - UNII:C4MO6809HU) LUFFA OPERCULATA FRUIT12 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-3382-11 in 1 CARTON11/01/2018
    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 homeopathic11/01/2018
    Labeler - Hyland's Inc. (008316655)
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