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 18, 2017

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

  • Drug Facts

    Active ingredients

    Active ingredients Purpose
    Acontitum Napellus 6X HPUS sneezing, watery eyes, sore throat with sudden onset
    Allium Cepa 6X HPUS red, watery eyes, runny nose, burning 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.

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  • Uses

    Temporarily relieves the symptoms of the common cold including sneezing, cough, watery eyes, runny nose, and sore throat.

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  • Warnings

    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
    • Inflammation, fever or infection develops
    • Symptoms are accompanied by high fever (101°F)
    • Cough tends to recur or is accompanied by 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 band is broken or missing.

    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 14 hours a day, 7 days per week at (800) 624-9659.

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  • Drug Facts (continued)

    Directions

    Children 2 years to under 6 years dissolve 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 years dissolve 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 over dissolve 4 tablets under tongue every 15 minutes for up to 8 doses until relieved; then every 4 hours as required

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  • Inactive ingredients

    Acacia Gum, Lactose.

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  • Questions or comments?

    (800) 624-9659

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  • 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

    SAFE &
    EFFECTIVE

    carton

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  • INGREDIENTS AND APPEARANCE
    SNIFFLES N SNEEZES 4 KIDS 
    aconitum napellus root, onion, gelsemium sempervirens root, and zinc gluconate tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3160
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACONITUM NAPELLUS ROOT (UNII: KPD2N7348X) (ACONITUM NAPELLUS ROOT - UNII:KPD2N7348X) ACONITUM NAPELLUS ROOT 6 [hp_X]
    ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION 6 [hp_X]
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT 6 [hp_X]
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37) ZINC GLUCONATE 2 [hp_X]
    Inactive Ingredients
    Ingredient Name Strength
    ACACIA (UNII: 5C5403N26O)  
    LACTOSE (UNII: J2B2A4N98G)  
    Product Characteristics
    Color white Score no score
    Shape ROUND Size 9mm
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54973-3160-1 1 in 1 CARTON 06/10/2013
    1 125 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 06/10/2013
    Labeler - Hyland's (028570695)
    Establishment
    Name Address ID/FEI Business Operations
    Standard Homeopathic Company 008316655 manufacture(54973-3160) , pack(54973-3160)
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