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

  • NDC Code(s): 54973-3375-1, 54973-3375-2, 54973-3375-3
  • 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 August 29, 2019

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

  • Drug Facts

    Active ingredients

    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

    “HPUS” indicates that the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.

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  • Uses

    • Temporarily relieves the symptoms of the common cold, 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

    Other information

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

    Inactive ingredients

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

    Questions or comments?

    (800) 624-9659

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  • SPL UNCLASSIFIED SECTION

    *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

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  • PRIMARY PRINCIPAL DISPLAY - 118 mL BOTTLE CARTON

    NDC 54973-3375-1

    HOMEOPATHIC

    Ages

    2-12

    NATURAL

    RELIEF

    SINCE 1903

    Hyland's

    4 Kids

    Cold'n

    Cough*

    NIGHTTIME

    Congestion

    Occasional Sleeplessness

    Runny Nose

    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

    C

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  • INGREDIENTS AND APPEARANCE
    4 KIDS COLD AND COUGH NIGHTTIME 
    onion, calcium sulfide, sodium chloride, anemone pulsatilla, arabica coffee bean, matricaria chamomilla, sulfur, phosphorus and goldenseal liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3375
    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) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 6 [hp_X]  in 1 mL
    ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA 6 [hp_X]  in 1 mL
    MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA 6 [hp_X]  in 1 mL
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL 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
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 12 [hp_X]  in 1 mL
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 12 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54973-3375-1 1 in 1 CARTON 07/01/2018
    1 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2 NDC:54973-3375-2 5 mL in 1 PACKET; Type 0: Not a Combination Product 07/01/2018
    3 NDC:54973-3375-3 1 in 1 CARTON 07/01/2018
    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 07/01/2018
    Labeler - Hyland's (028570695)
    Establishment
    Name Address ID/FEI Business Operations
    Nexgen Pharma, Inc. 079424083 manufacture(54973-3375) , pack(54973-3375) , label(54973-3375)
    Establishment
    Name Address ID/FEI Business Operations
    Applied Laboratories, Inc. 876754375 manufacture(54973-3375) , pack(54973-3375) , label(54973-3375)
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