Label: SNIFFLES N SNEEZES 4 KIDS- aconitum napellus root, onion, gelsemium sempervirens root, and zinc gluconate tablet

  • 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 December 14, 2022

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

  • Drug Facts

    Active ingredients

    Active ingredientsPurpose
    Acontitum Napellus 6X HPUS

    sneezing, watery eyes, sore throat

    Allium Cepa 6X HPUS

    red/watery eyes, runny nose, nasal discharge

    Gelsemium Sempervirens 6X HPUS

    sneezing, headache, sore throat, cough

    Zincum Gluconium 2X HPUS

    runny nose and sore throat

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

  • Uses

    Uses

    Temporarily relieves the symptoms of the common cold, including:

    • sneezing
    • cough
    • watery eyes
    • runny nose
    • sore throat
    • headache
  • Warnings

    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.
    • inflammation, fever or infection develops.
    • symptoms are accompanied by a high fever (over 101°F).
    • cough tends to recur or is accompanied by a high fever, rash or persistent headache.

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

    In case of accidental overdose, contact a medical professional or a poison control center immediately.

    Do not use this product for persistent or chronic cough such as asthma, smoking or emphysema or if cough is accompanied by excessive mucus, unless directed by a licensed health care professional.

    A persistent cough may be a sign of a serious condition.

    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.

    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.

  • Drug Facts (continued)

    Directions

    Children 2 years to under 6 yearsdissolve 2 tablets under tongue every 15 minutes for up to 8 doses until relieved; then every 4 hours as required
    Children 6 years to under 12 yearsdissolve 3 tablets under tongue every 15 minutes for up to 8 doses until relieved; then every 4 hours as required
    Adults and children 12 years and overdissolve 4 tablets under tongue every 15 minutes for up to 8 doses until relieved; then every 4 hours as required

  • Inactive ingredients

    Acacia Gum, Lactose.

  • Questions or comments?

    (800) 624-9659

  • PRINCIPAL DISPLAY PANEL - 125 Tablet Bottle Carton

    Natural
    Relief

    NDC 54973-3160-1
    HOMEOPATHIC

    Ages
    2-12

    SINCE 1903

    Hyland's®
    4Kids

    Sniffles 'n
    Sneezes

    Runny Nose & Sore Throat

    Sneezing

    Cough

    ACTUAL SIZE 65 MG

    125 QUICK-DISSOLVING TABLETS

    *SEE NOTE ON BACK PANEL BELOW DRUG FACTS

    carton

  • INGREDIENTS AND APPEARANCE
    SNIFFLES N SNEEZES 4 KIDS 
    aconitum napellus root, onion, gelsemium sempervirens root, and zinc gluconate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3160
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACONITUM NAPELLUS ROOT (UNII: KPD2N7348X) (ACONITUM NAPELLUS ROOT - UNII:KPD2N7348X) ACONITUM NAPELLUS ROOT6 [hp_X]
    ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION6 [hp_X]
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT6 [hp_X]
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37) ZINC GLUCONATE2 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    ACACIA (UNII: 5C5403N26O)  
    LACTOSE (UNII: J2B2A4N98G)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-3160-11 in 1 CARTON06/10/2013
    1125 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/10/2013
    Labeler - Hyland's Inc. (008316655)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hyland's Inc.008316655manufacture(54973-3160) , pack(54973-3160)