Label: 4 KIDS COLD AND COUGH NIGHTTIME NATURAL GRAPE FLAVOR- onion,anemone pulsatilla, phosphorus, goldenseal, calcium sulfide, sodium chloride, sulfur, matricaria chamomilla and arabica coffee bean liquid

  • NDC Code(s): 54973-3377-1, 54973-3377-2, 54973-3377-3
  • 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 September 5, 2019

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

  • Drug Facts

    Active ingredients

    Allium Cepa 6X HPUS,Chamomilla 6X HPUS,Coffea Cruda 6X HPUS,Hepar Sulph Calc 12X HPUS,Hydrastis 6X HPUS

    Natrum Muriaticum 6X, 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

    Chamomilla 6X HPUS ......... sensitive, irritable, fussy, nocturnal occasional sleeplessness

    Coffea Cruda 6X HPUS........occasional sleeplessness, restlessness

    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, post nasal drip

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

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  • Uses

    • Temporarily relieves symptoms of common cold in children especially at night, including:
    • cough 
    • runny nose 
    • post nasal drip
    • sneezing 
    • nasal or chest congestion
    • sore throat with accompanying occasional sleeplessness
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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 (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.

    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.

    In case of emergency or accidental overdose, 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

    • Shake well before using.
    • Measure only with the dosing cup provided.
    • Do not use dosing cup with other products.
    • On dosing cup, mL = milliliter.

    Children 2 years

    to under 6 years

    5 mL at bedtime and every

    4 hours during the night

    until relieved

    Children 6 years

    to under 12 years

    10 mL at bedtime and every

    4 hours during the night

    until relieved

    Adults and children

    12 years and over

    15 mL at bedtime and every

    4 hours during the night

    until relieved

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  • Other information

    • Do not use if imprinted "SEALED FOR YOUR PROTECTION" tamper-evident bottle cap band is broken or missing.
    • The inner packaged bottle is child-resistant.
    • Store at room temperature.
    • Do not refrigerate.
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  • Inactive ingredients

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

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  • Questions or comments?

    (800) 624-9659

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  • Principal Display Panel - 4 FL OZ (118 mL) Bottle Carton

    NDC 54973-3377-1

    HOMEOPATHIC

    Ages

    2-12

    NATURAL

    RELIEF

    SINCE 1903

    Hyland's

    4 Kids

    Cold 'n Cough*

    Nighttime

    Natural Grape Flavor

    Congestion

    Ocassional Sleeplessness

    Runny Nose

    Sore Throat

    Sneezing

    Cough

    +also relieves

    Post Nasal Drip

    ALCOHOL FREE

    SUGAR FREE

    DYE FREE

    4 FL. OZ. (118 mL)

    *SEE NOTE ON SIDE PANEL BELOW DRUG FACTS

    carton

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  • INGREDIENTS AND APPEARANCE
    4 KIDS COLD AND COUGH NIGHTTIME NATURAL GRAPE FLAVOR 
    onion,anemone pulsatilla, phosphorus, goldenseal, calcium sulfide, sodium chloride, sulfur, matricaria chamomilla and arabica coffee bean liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3377
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 6 [hp_X]  in 1 mL
    ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION 6 [hp_X]  in 1 mL
    MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA 6 [hp_X]  in 1 mL
    ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN 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
    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)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor GRAPE Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54973-3377-1 1 in 1 CARTON 11/01/2018
    1 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2 NDC:54973-3377-2 5 mL in 1 PACKET; Type 0: Not a Combination Product 11/01/2018
    3 NDC:54973-3377-3 1 in 1 CARTON 11/01/2018
    3 148 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 11/01/2018
    Labeler - Hyland's (028570695)
    Establishment
    Name Address ID/FEI Business Operations
    Standard Homeopathic Company 008316655 manufacture(54973-3377) , pack(54973-3377) , label(54973-3377)
    Establishment
    Name Address ID/FEI Business Operations
    Nexgen Pharma, Inc. 079424083 manufacture(54973-3377) , pack(54973-3377) , label(54973-3377)
    Establishment
    Name Address ID/FEI Business Operations
    Applied Laboratories, Inc. 876754375 manufacture(54973-3377) , pack(54973-3377) , label(54973-3377)
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