Label: 4 KIDS COLD N COUGH DAY AND NIGHT VALUE PACK- onion, calcium sulfide, sodium chloride, phosphorus, pulsatilla vulgaris, sulfur, goldenseal, strychnos nux-vomica seed, coffee bean, and chamomile

  • NDC Code(s): 54973-3075-1, 54973-3098-1, 54973-3177-1
  • Packager: Hylands Inc.
  • 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 29, 2018

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

  • DAYTIME Drug Facts

    Active ingredients Purpose
    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

    "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 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 band is broken or missing.

    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, tsp = teaspoon
    Children 2 years to under 6 years 5 mL or 1 teaspoon up to 6 times per day (every 4 hours)
    Children 6 years to under 12 years 10 mL or 2 teaspoons up to 6 times per day (every 4 hours)
    Adults and children 12 years and over 15 mL or 3 teaspoons up to 6 times per day (every 4 hours)
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  • Inactive ingredients

    Citric Acid USP, Glycyrrhiza Extract, Purified Water USP, Sodium Benzoate N.F., Vegetable Glycerine USP.

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  • NIGHTTIME 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
    Nux Vomica 6X HPUS tired, difficulty falling asleep, frequent waking
    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

    "HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopœia of the United States

    Close
  • Uses

    Temporarily relieves the symptoms of the common cold including cough, runny nose, sneezing, nasal and chest congestion, and sore throat with occasional sleeplessness.

    Close
  • 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 band is broken or missing.

    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.

    Close
  • Directions

    • Measure only with the dosing cup provided
    • Do not use dosing cup with other products
    • On dosing cup, 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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  • PRINCIPAL DISPLAY PANEL - Kit Carton

    Natural
    Relief

    NDC 54973-3177-1
    HOMEOPATHIC*

    Ages
    2-12

    SINCE 1903
    Hyland's®

    4 Kids

    Cold 'n Cough*

    Day & Night Value Pack

    DAYTIME

    Nasal Congestion

    Runny Nose

    Sore Throat

    Sneezing

    Cough

    ALCOHOL FREE

    SUGAR FREE
    DYE FREE

    4 FL. OZ. (118 mL) Daytime

    NIGHTTIME

    Chest Congestion

    Occasional Sleeplessness

    Runny Nose

    Sore Throat

    Sneezing

    Cough

    ALCOHOL FREE
    SUGAR FREE
    DYE FREE

    4 FL. OZ. (118 mL) Nighttime

    8 FL. OZ. (236 mL) TOTAL

    carton_1

    carton_2

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  • INGREDIENTS AND APPEARANCE
    4 KIDS COLD N COUGH DAY AND NIGHT VALUE PACK 
    onion, calcium sulfide, sodium chloride, phosphorus, pulsatilla vulgaris, sulfur, goldenseal, strychnos nux-vomica seed, coffee bean, and chamomile kit
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3177
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54973-3177-1 1 in 1 CARTON; Type 0: Not a Combination Product 12/01/2013
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 1 BOTTLE, PLASTIC 118 mL
    Part 2 1 BOTTLE, PLASTIC 118 mL
    Part 1 of 2
    COLD N COUGH 4 KIDS 
    onion, calcium sulfide, sodium chloride, phosphorus, pulsatilla vulgaris, sulfur, and goldenseal liquid
    Product Information
    Item Code (Source) NDC:54973-3075
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS 6 [hp_X]  in 1 mL
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 12 [hp_X]  in 1 mL
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL 6 [hp_X]  in 1 mL
    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) (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
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54973-3075-1 118 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 08/01/2008
    Part 2 of 2
    NIGHTTIME COLD N COUGH 4 KIDS 
    onion, coffee bean, chamomile, calcium sulfide, goldenseal, sodium chloride, strychnos nux-vomica seed, phosphorus, pulsatilla vulgaris, and sulfur liquid
    Product Information
    Item Code (Source) NDC:54973-3098
    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) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 6 [hp_X]  in 1 mL
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED 6 [hp_X]  in 1 mL
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 12 [hp_X]  in 1 mL
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS 6 [hp_X]  in 1 mL
    COFFEE BEAN (UNII: JFH385Y744) (COFFEE BEAN - UNII:JFH385Y744) COFFEE BEAN 6 [hp_X]  in 1 mL
    CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE 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)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54973-3098-1 118 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 07/01/2010
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 12/01/2013
    Labeler - Hylands Inc. (028570695)
    Establishment
    Name Address ID/FEI Business Operations
    Standard Homeopathic Company 008316655 manufacture(54973-3177) , pack(54973-3177)
    Establishment
    Name Address ID/FEI Business Operations
    Nexgen Pharma, INC 079424083 manufacture(54973-3177) , pack(54973-3177) , label(54973-3177)
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