Label: 4 KIDS COLD AND MUCUS NIGHTTIME- euphrasia stricta,silicon dioxide, rumex crispus root, anemone pulsatilla, goldenseal, sodium chloride, phosphorus, onion, bryonia alba root, matricaria chamomilla, arabica coffee bean, calcium sulfide and sulfur liquid

  • NDC Code(s): 54973-3372-1, 54973-3372-2, 54973-3372-3
  • 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 November 1, 2018

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

  • Drug Facts

    Active ingredients

    Purpose

    Allium Cepa 6X HPUS

    runny nose with mucus, hacking cough, sore throat

    Bryonia Alba 6X HPUS

    stubborn mucus in throat, cough with yellowish mucus

    Chamomilla 3X HPUS

    irritability, fussiness, occasional sleeplessness

    Coffea Cruda 3X HPUS

    occasional sleeplessness, restlessness

    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

    Hydrastis 6X HPUS

    cough with mucus, dry, sore throat, occasional sleeplessness due to mucus in throat

    Natrum Muriaticum 6X 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

    Sulphur 12X HPUS

    cough with thick mucus, chest congestion, nasal congestion

    “HPUS” indicates that 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 in children especially at night including accumulation of mucus in chest, throat and nose, cough with mucus, runny nose, sneezing, nasal congestion and 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. 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 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.

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  • Drug Facts (continued)

    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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  • 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 at bedtime and every 4 hours during the night or as necessary

    Children 6 years to under 12 years

    10 mL or 2 teaspoons at bedtime and every 4 hours during the night or as necessary

    Adults and children 12 years and over

    15 mL or 3 teaspoons at bedtime and every 4 hours during the night or as necessary

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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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  • PRIMARY PRINCIPAL DISPLAY - 4 FL. OZ. (118 mL) BOTTLE CARTON

    NDC 54973-3372-2

    HOMEOPATHIC

    Ages

    2-12

    NATURAL

    RELIEF

    SINCE 1903

    Hyland's

    4KIDS

    Cold'n

    Mucus

    NIGHTTIME

    Loosens mucus in

    chest, throat and nose

    Mucus & Congestion

    Occasional Sleeplessness

    Runny Nose

    Cough

    LESS THAN 0.2%ALCOHOL

    SUGAR FREE

    DYE FREE

    4 FL. OZ. (118 mL)

    carton1

    carton2

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  • INGREDIENTS AND APPEARANCE
    4 KIDS COLD AND MUCUS NIGHTTIME 
    euphrasia stricta,silicon dioxide, rumex crispus root, anemone pulsatilla, goldenseal, sodium chloride, phosphorus, onion, bryonia alba root, matricaria chamomilla, arabica coffee bean, calcium sulfide and sulfur liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3372
    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
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 6 [hp_X]  in 1 mL
    MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA 3 [hp_X]  in 1 mL
    EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA 6 [hp_X]  in 1 mL
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL 6 [hp_X]  in 1 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 6 [hp_X]  in 1 mL
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 12 [hp_X]  in 1 mL
    ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN 3 [hp_X]  in 1 mL
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE 12 [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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54973-3372-2 1 in 1 CARTON 06/27/2018
    1 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2 NDC:54973-3372-1 1 in 1 CARTON 08/01/2018
    2 148 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3 NDC:54973-3372-3 5 mL in 1 PACKET; Type 0: Not a Combination Product 06/27/2018
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 06/27/2018
    Labeler - Hyland's (028570695)
    Establishment
    Name Address ID/FEI Business Operations
    Nexgen Pharma, Inc. 079424083 pack(54973-3372) , label(54973-3372) , manufacture(54973-3372)
    Establishment
    Name Address ID/FEI Business Operations
    Applied Laboratories, Inc. 876754375 manufacture(54973-3372) , pack(54973-3372) , label(54973-3372)
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