Label: 4 KIDS COMPLETE COLD AND FLU- anas platyrhynchos feather, bryonia alba root, eupatorium perfoliatum flowering top, euphrasia stricta, gelsemium sempervirens root, and potassium iodide 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 30, 2018

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active ingredients Purpose
    " HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
    Anas Barbariae Hepatis Et Cordis Extractum 200C HPUS early onset flu symptoms
    Bryonia 6X HPUS body aches, headaches, cough
    Eupatorium Perfoliatum 6X HPUS body aches, headaches, cough
    Euphrasia Officinalis 6X HPUS runny nose, cough, fever, chills, congestion
    Gelsemium Sempervirens 6X HPUS aches and pain, fever, fatigue
    Kali Iodatum 6X HPUS headache, runny nose, fever, sore throat
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  • Uses

    Temporarily relieves the symptoms of the common cold and flu including body aches and headaches, cough and congestion, fever, chills, 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 occurs with 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.

    There have been no reports of interactions between this product and ibuprofen or acetaminophen.

    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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  • 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 teaspoon up to 6 times per day (every 4 hours)
    children 6 years 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)
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  • Inactive ingredients

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

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  • Questions or comments?

    (800) 624-9659

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  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

    New!

    Natural
    Relief

    NDC 54973-3186-1
    HOMEOPATHIC

    Ages
    2-12

    SINCE 1903
    Hyland's
    4Kids

    Complete
    Cold 'n Flu
    *

    Body Aches & Headache

    Cough & Congestion

    Fever & Chills

    Sore Throat

    LESS THAN 0.1% ALCOHOL
    SUGAR FREE
    DYE FREE

    SAFE &
    EFFECTIVE

    4 FL. OZ. (118 mL)

    Principal Display Panel - 118 mL Bottle Carton
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  • INGREDIENTS AND APPEARANCE
    4 KIDS COMPLETE COLD AND FLU 
    anas platyrhynchos feather, bryonia alba root, eupatorium perfoliatum flowering top, euphrasia stricta, gelsemium sempervirens root, and potassium iodide liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3186
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ANAS PLATYRHYNCHOS FEATHER (UNII: 83B65P4796) (ANAS PLATYRHYNCHOS FEATHER - UNII:83B65P4796) ANAS PLATYRHYNCHOS FEATHER 200 [hp_C]  in 1 mL
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 6 [hp_X]  in 1 mL
    EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E) EUPATORIUM PERFOLIATUM FLOWERING TOP 6 [hp_X]  in 1 mL
    EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA 6 [hp_X]  in 1 mL
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT 6 [hp_X]  in 1 mL
    POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION 6 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54973-3186-1 1 in 1 CARTON 04/14/2014
    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 04/14/2014
    Labeler - Hyland's (028570695)
    Establishment
    Name Address ID/FEI Business Operations
    Standard Homeopathic Company 008316655 manufacture(54973-3186) , pack(54973-3186)
    Establishment
    Name Address ID/FEI Business Operations
    Nexgen Pharma, Inc. 079424083 manufacture(54973-3186) , pack(54973-3186) , label(54973-3186)
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