Label: 4 KIDS COLD AND COUGH DAYTIME- onion, calcium sulfide, sodium chloride, phosphorus, pulsatilla vulgaris, sulfur, and goldenseal 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 January 25, 2019

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

  • Drugs Facts

    Active ingredients

    Allium Cepa 6X HPUS

    Hepar Sulph Calc 12X HPUS

    Hydrastis 6X HPUS

    Natrum Muriaticum 6X HPUS

    Phosphorus 12X HPUS

    Pulsatilla 6X HPUS

    Sulphur 12X HPUS

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

    Purpose

    Allium Cepa 6X HPUS..........................watery/runny nose, cold, hacking cough, painful throat

    Hepar Sulph Calc 12X HPUS................cold, sneezing

    Hydrastis 6X HPUS................................rattling/tickling cough, sinus congestion, dry/raw/sore throat

    Natrum Muriaticum 6X HPUS................dry cough, sore throat

    Phosphorus 12X HPUS.........................hoarse/dry cough, nasal congestion, chest congestion

    Pulsatilla 6X HPUS................................moist cough, cold, nasal congestion

    Sulphur 12X HPUS................................chest congestion, nasal congestion, sneezing, runny nose

    Uses

    Temporarily relieves the symptoms of the common cold including: nasal or chest congestion, runny nose, sore throat, sneezing, cough.

    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 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 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 medical 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.

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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)

    Inactive ingredients

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

    Questions or comments?

    (800) 624-9659

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  • Principal Display Panel - 148 mL Bottle Carton

    25% MORE

    BONUS PACK

    NDC 54973-3400-1

    HOMEOPATHIC

    Ages

    2-12

    NATURAL

    RELIEF

    SINCE 1903

    Hyland's

    4Kiids

    Cold 'n

    Cough*

    DAYTIME

    Congestion

    Runny Nose

    Sore Throat

    Sneezing

    Cough

    ALCOHOL FREE

    SUGAR FREE

    DYE FREE

    4 + 1 = 5 S FL. OZ. (148 mL)

    Carton

    Close
  • INGREDIENTS AND APPEARANCE
    4 KIDS COLD AND COUGH DAYTIME 
    onion, calcium sulfide, sodium chloride, phosphorus, pulsatilla vulgaris, sulfur, and goldenseal liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3400
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION 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) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE 6 [hp_X]  in 1 mL
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 12 [hp_X]  in 1 mL
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 12 [hp_X]  in 1 mL
    ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA 6 [hp_X]  in 1 mL
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL 6 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54973-3400-1 1 in 1 CARTON 08/01/2008
    1 148 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 08/01/2008
    Labeler - Hyland's (028570695)
    Establishment
    Name Address ID/FEI Business Operations
    Standard Homeopathic Company 008316655 manufacture(54973-3400) , pack(54973-3400) , label(54973-3400)
    Establishment
    Name Address ID/FEI Business Operations
    Nexgen Pharma, Inc. 079424083 manufacture(54973-3400) , pack(54973-3400) , label(54973-3400)
    Establishment
    Name Address ID/FEI Business Operations
    Applied Laboratories, Inc. 876754375 manufacture(54973-3400) , pack(54973-3400) , label(54973-3400)
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