Label: COMPLETE ALLERGY 4 KIDS- aconitum napellus, onion, euphrasia stricta, galphimia glauca flowering top, histamine dihydrochloride, luffa operculata fruit, sodium chloride, strychnos nux-vomica seed, pulsatilla vulgaris, and schoenocaulon officinale seed liquid

  • NDC Code(s): 54973-3097-1, 54973-3097-2
  • 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 June 8, 2020

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Aconitum Napellus 6X HPUSitchy throat, sneezing
    Allium Cepa 6X HPUShay fever, runny nose, watery, itchy eyes
    Euphrasia 6X HPUSnasal inflammation, nasal discharge
    Galphimia Glauca 12X HPUSsneezing, runny nose
    Histaminum Hydrochloricum 12X HPUSear pain
    Luffa Operculata 12X HPUSsinus pain, headache
    Natrum Muriaticum 6X HPUSear pain, itchy, burning eyes

    Nux Vomica 6X HPUS

    (0.0000016% Alkaloids, calculated)
    itchy nose
    Pulsatilla 6X HPUSsinus pressure
    Sabadilla 6X HPUShay fever, uncontrollable sneezing

    “HPUS” indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.

  • Uses

    • Temporarily relieves the symptoms of indoor and outdoor allergens including runny nose, itchy, watery eyes, itchy nose and throat, stuffy nose and facial pain.
  • Warnings

    Do not use to treat food allergies.

    As with any drug, ask a doctor before use if pregnant or nursing.

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

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

    Do not use if imprinted tamper band is broken or missing.

    In case of emergency

    Contact a medical professional or Poison Control Center immediately. Hyland's may be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659

  • Drug Facts (continued)

    Directions

    • Measure only with the dosing cup provided
    • Do not use dosing cup with other products
    • On dosing cup, tsp = teaspoon

    Children ages 2-under 6 years: 5 mL or 1 teaspoon up to 6 times per day (every 4 hours).

    Children 6 to under 12 years: 10 mL or 2 teaspoons up to 6 times per day (every 4 hours).

    Adults and children 12 years and over: 15 mL or 3 teaspoons up to 6 times per day (every 4 hours)

  • Inactive Ingredients

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

  • Questions or comments?

    (800) 624-9659

  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

    Natural
    Relief

    NDC 54973-3097-1
    HOMEOPATHIC*

    Ages
    2-12

    SINCE 1903
    Hyland's®

    4 Kids

    Complete
    Allergy *

    Itchy Nose & Throat

    Itchy, Watery Eyes

    Runny Nose

    Sneezing


    ALCOHOL FREE
    SUGAR FREE
    DYE FREE

    SAFE &
    EFFECTIVE

    4 FL. OZ. (118 mL)

    Carton

  • INGREDIENTS AND APPEARANCE
    COMPLETE ALLERGY 4 KIDS 
    aconitum napellus, onion, euphrasia stricta, galphimia glauca flowering top, histamine dihydrochloride, luffa operculata fruit, sodium chloride, strychnos nux-vomica seed, pulsatilla vulgaris, and schoenocaulon officinale seed liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3097
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS6 [hp_X]  in 1 mL
    ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION6 [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
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE6 [hp_X]  in 1 mL
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED6 [hp_X]  in 1 mL
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS6 [hp_X]  in 1 mL
    SCHOENOCAULON OFFICINALE SEED (UNII: 6NAF1689IO) (SCHOENOCAULON OFFICINALE SEED - UNII:6NAF1689IO) SCHOENOCAULON OFFICINALE SEED6 [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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-3097-1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/01/2010
    2NDC:54973-3097-219.8 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/01/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/01/2010
    Labeler - Hyland's, Inc. (028570695)
    Establishment
    NameAddressID/FEIBusiness Operations
    Standard Homeopathic Company008316655manufacture(54973-3097)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lifetech Resources081239587manufacture(54973-3097) , pack(54973-3097)