Label: 4 KIDS COLD N COUGH- onion, calcium sulfide, goldenseal, sodium chloride, phosphorus, anemone pulsatilla, and sulfur 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 May 13, 2016

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

  • 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 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 nasal and chest congestion, runny nose, sore throat, sneezing and cough.

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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
    • Inflammation, fever or infection develops
    • Symptoms are accompanied by a high fever (101F°)
    • 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 a 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 package is torn or damaged. 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

    Children 2-6 years, one packet (5mL) up to 6 times per day (every 4 hours). Children 6-12 years, 2 packets (10mL) up to 6 times per day (every 4 hours). Adults and children over 12, 3 packets (15mL) 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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  • PRINCIPAL DISPLAY PANEL - 5 mL Packet Label

    NDC 54973-3283-1
    HOMEOPATHIC

    SAFE & EFFECTIVE

    Ages
    2-12

    Natural
    Relief

    SINCE 1903
    Hyland's®
    4Kids

    Cold 'n Cough*

    Nasal Congestion

    Runny Nose

    Sore Throat

    Sneezing

    Cough

    5 mL
    (0.17 FL. OZ.)

    PRINCIPAL DISPLAY PANEL - 5 mL Packet Label
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  • INGREDIENTS AND APPEARANCE
    4 KIDS COLD N COUGH 
    onion, calcium sulfide, goldenseal, sodium chloride, phosphorus, anemone pulsatilla, and sulfur liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3283
    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
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL 6 [hp_X]  in 1 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE 6 [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
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 12 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LICORICE (UNII: 61ZBX54883)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54973-3283-1 5 mL in 1 PACKET; Type 0: Not a Combination Product 05/13/2016
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED HOMEOPATHIC 05/13/2016
    Labeler - Hyland's (028570695)
    Establishment
    Name Address ID/FEI Business Operations
    Standard Homeopathic Company 008316655 MANUFACTURE(54973-3283) , PACK(54973-3283)
    Establishment
    Name Address ID/FEI Business Operations
    Applied Laboratories, Inc. 876754375 MANUFACTURE(54973-3283) , PACK(54973-3283)
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