Label: 4 KIDS COLD N COUGH GRAPE FLAVOR- onion, calcium sulfide, goldenseal, sodium chloride, phosphorus, anemone pulsatilla, and sulfur liquid

  • NDC Code(s): 54973-3243-1, 54973-3243-2, 54973-3243-3, 54973-3243-4
  • 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 January 28, 2019

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

  • Drug Facts

    Active ingredients Purpose
    "HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
    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 and chest congestion, runny nose, sore throat, sneezing and 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 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-evident bottle band is broken or missing.

    Do not use if imprinted tamper-evident bottle 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 tsp up to 6 times per day

    (every 4 hours)

    Children 6 years

    to under 12 years

    10 mL or 2 tsp up to 6 times per day

    (every 4 hours)

    Adults and children

    12 years and over

    15 mL or 3 tsp up to

    6 times per day (every 4 hours)

    Inactive ingredients

    Citric Acid, Glycerine, Glycyrrhiza Extract, Natural Grape Flavoring, Purified Water, Sodium Benzoate.

    Questions or comments?

    (800) 624-9659

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  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

    NDC 54973-3243-1
    HOMEOPATHIC

    Ages 2-12

    NATURAL

    RELIEF

    SINCE 1903
    Hyland's
    4Kids

    Cold 'n
    Cough*

    Natural Grape Flavor

    Congestion

    Runny Nose

    Sore Throat

    Sneezing

    Cough


    ALCOHOL FREE

    SUGAR FREE
    DYE FREE

    4 FL. OZ. (118 mL)

    carton

    Close
  • INGREDIENTS AND APPEARANCE
    4 KIDS COLD N COUGH GRAPE FLAVOR 
    onion, calcium sulfide, goldenseal, sodium chloride, phosphorus, anemone pulsatilla, and sulfur liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3243
    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)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor GRAPE (Natural Grape Flavor) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54973-3243-1 1 in 1 CARTON 02/10/2016
    1 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2 NDC:54973-3243-2 1 in 1 CARTON 02/10/2016
    2 236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3 NDC:54973-3243-3 5 mL in 1 POUCH; Type 0: Not a Combination Product 02/10/2016
    4 NDC:54973-3243-4 1 in 1 CARTON 02/10/2016
    4 148 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 02/10/2016
    Labeler - Hyland's (028570695)
    Establishment
    Name Address ID/FEI Business Operations
    Standard Homeopathic Company 008316655 manufacture(54973-3243) , pack(54973-3243)
    Establishment
    Name Address ID/FEI Business Operations
    Applied Laboratories, Inc. 876754375 manufacture(54973-3243) , pack(54973-3243)
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