Label: 4 KIDS COMPLETE COLD AND MUCUS- bryonia alba root, euphrasia stricta, calcium sulfide, sodium chloride, phosphorus, anemone pulsatilla, rumex crispus root, and silicon dioxide liquid

  • NDC Code(s): 54973-3179-1, 54973-3179-2, 54973-3179-4
  • Packager: Hyland's
  • 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 3, 2019

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

  • Drug Facts

    Active ingredients Purpose
    Bryonia 6X HPUS stubborn mucus in throat, cough with yellowish mucus
    Euphrasia Officinalis 6X HPUS cough with mucus in chest
    Hepar Sulph Calc 12X HPUS cough up mucus, mucus rattle with cough, stubborn mucus in chest
    Natrum Muriaticum 30X HPUS accumulation of mucus in throat, cough up mucus
    Phosphorus 30X HPUS cough with expectoration of yellow mucus, chest congestion
    Pulsatilla 6X HPUS accumulation of mucus, discharge of thick yellowish mucus, loose cough
    Rumex Crispus 6X HPUS runny nose, sneezing
    Silicea 12X HPUS nasal congestion

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

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  • Uses

    Temporarily relieves symptoms of colds, including accumulation of mucus in chest, throat and nose; cough with expectoration of thick, discolored mucus; runny nose, sneezing and nasal congestion.

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  • 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
    • infalmation, 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 accompanied by high fever, headache,nausea and vomitting me ay be serious. Consult a doctor promptly.

    Do not use if imprinted tamper-evident bottle 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 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 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,Glycerine,Glycyrrhiza Extract, Purified Water, Sodium Benzoate.

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  • Questions or comments?

    (800) 624-9659

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  • PURPOSE

    Temporarily relieves symptoms of colds, including accumulation of mucus in chest, throat and nose; cough with expectoration of thick, discolored mucus; runny nose, sneezing and nasal congestion.

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  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

    NDC 54973-3179-1

    HOMEOPATHIC

    Ages
    2-12

    Natural
    Relief

    SINCE 1903
    Hyland's®
    4 Kids

    Cold 'n
    Mucus
    *

    DAYTIME

    Loosens mucus in
    chest, throat and nose

    Mucus & Congestion

    Runny Nose

    Cough

    ALCOHOL FREE
    SUGAR FREE
    DYE FREE

    4 FL. OZ. (118 mL)

    carton

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  • INGREDIENTS AND APPEARANCE
    4 KIDS COMPLETE COLD AND MUCUS 
    bryonia alba root, euphrasia stricta, calcium sulfide, sodium chloride, phosphorus, anemone pulsatilla, rumex crispus root, and silicon dioxide liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3179
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 6 [hp_X]  in 1 mL
    EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA 6 [hp_X]  in 1 mL
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE 12 [hp_X]  in 1 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 30 [hp_X]  in 1 mL
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 30 [hp_X]  in 1 mL
    ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA 6 [hp_X]  in 1 mL
    RUMEX CRISPUS ROOT (UNII: 9N1RM2S62C) (RUMEX CRISPUS ROOT - UNII:9N1RM2S62C) RUMEX CRISPUS ROOT 6 [hp_X]  in 1 mL
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 12 [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:54973-3179-1 1 in 1 CARTON 07/01/2014
    1 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2 NDC:54973-3179-2 1 in 1 CARTON 10/17/2014
    2 19.8 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3 NDC:54973-3179-4 10 in 1 CARTON 07/01/2014
    3 5 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 07/01/2014
    Labeler - Hyland's (028570695)
    Establishment
    Name Address ID/FEI Business Operations
    Standard Homeopathic Company 008316655 manufacture(54973-3179) , pack(54973-3179)
    Establishment
    Name Address ID/FEI Business Operations
    Nexgen Pharma, Inc. 079424083 manufacture(54973-3179) , pack(54973-3179)
    Establishment
    Name Address ID/FEI Business Operations
    Applied Laboratories, Inc. 117337220 pack(54973-3179)
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