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 2, 2018

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

  • 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

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  • Uses

    Temporarily relieves the symptoms of indoor and outdoor allergens, including: • itchy nose or throat • itchy • watery or burning eyes • runny nose • sneezing • headache • sinus pain or pressure

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  • Warnings

    Do not use

    to treat food allergies.

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

    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 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.

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  • Drug Facts (continued)

    Directions

    • Measure only with the dosing cup provided

    • Do not use dosing cup with other products

    • On dosing cup, mL = milliliter, tsp = teaspoon

    Children 2 years

    to under 6 years

    5 mL or 1 tsp up to

    6 times per day (every 4 hours)

    Children 6 years

    to under 12 years

    10 mL or 2 tsp up to

    6 times per day (every 4 hours)

    Adults and children

    12 years and over

    15 mL or 3 tsp up to

    6 times per day (every 4 hours)

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  • Inactive ingredients

    Citric Acid, Glycerine, Glycyrrhiza Extract, Purified Water, Sodium Benzoate.

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  • Questions or comments?

    (800) 624-9659

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  • PRINCIPAL DISPLAY PANEL - 4 FL. OZ. (118 mL) Bottle Carton

    NDC 54973-3382-1

    HOMEOPATHIC

    Ages

    2-12

    NATURAL

    RELIEF

    SINCE 1903

    Hyland's

    4 Kids

    Complete

    Allergy*

    DAYTIME

    Itchy Nose & Throat

    Watery Eyes

    Runny Nose

    Sneezing

    ALCOHOL FREE

    SUGAR FREE

    DYE FRE

    4 FL. OZ. (118 mL)

    Carton

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  • 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 Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3382
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 6 [hp_X]  in 1 mL
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS 6 [hp_X]  in 1 mL
    EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA 6 [hp_X]  in 1 mL
    GALPHIMIA GLAUCA FLOWERING TOP (UNII: 93PH5Q8M7E) (GALPHIMIA GLAUCA FLOWERING TOP - UNII:93PH5Q8M7E) GALPHIMIA GLAUCA FLOWERING TOP 12 [hp_X]  in 1 mL
    HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE 12 [hp_X]  in 1 mL
    LUFFA OPERCULATA FRUIT (UNII: C4MO6809HU) (LUFFA OPERCULATA FRUIT - UNII:C4MO6809HU) LUFFA OPERCULATA FRUIT 12 [hp_X]  in 1 mL
    SCHOENOCAULON OFFICINALE SEED (UNII: 6NAF1689IO) (SCHOENOCAULON OFFICINALE SEED - UNII:6NAF1689IO) SCHOENOCAULON OFFICINALE SEED 6 [hp_X]  in 1 mL
    ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION 6 [hp_X]  in 1 mL
    ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA 6 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54973-3382-1 1 in 1 CARTON 11/01/2018
    1 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 11/01/2018
    Labeler - Hyland's Inc. (028570695)
    Establishment
    Name Address ID/FEI Business Operations
    Standard Homeopathic Company 008316655 manufacture(54973-3382)
    Establishment
    Name Address ID/FEI Business Operations
    Lifetech Resources 622559110 manufacture(54973-3382) , pack(54973-3382) , label(54973-3382)
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