Label: 4 KIDS COLD N COUGH DAY AND NIGHT COMBO PACK- onion, calcium sulfide, goldenseal, sodium chloride, phosphorus, anemone pulsatilla, sulfur, matricaria recutita, arabica coffee bean, and strychnos nux-vomica seed

  • NDC Code(s): 54973-3243-2, 54973-3245-1, 54973-3282-1
  • 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 June 28, 2016

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

  • SPL UNCLASSIFIED SECTION

    DAYTIME

    Drug Facts

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  • ACTIVE INGREDIENT

    Active ingredients Purpose
    "HPUS" indicates that 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
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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 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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  • 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 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, Glycerine, Glycyrrhiza Extract, Natural Grape Flavor, Purified Water, Sodium Benzoate.

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  • SPL UNCLASSIFIED SECTION

    NIGHTTIME

    Drug Facts

    Close
  • ACTIVE INGREDIENT

    Active ingredients Purpose
    "HPUS" indicates that 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
    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
    (0.0000016% Alkaloids, calculated)
    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
    Close
  • Uses

    Temporarily relieves the symptoms of the common cold including cough, runny nose, sneezing, nasal and chest congestion, and sore throat with accompanying 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 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, 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
    Close
  • Inactive ingredients

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

    Close
  • Questions or comments?

    (800) 624-9659

    Close
  • PRINCIPAL DISPLAY PANEL - Kit Carton

    Natural Grape Flavor!

    Natural
    Relief

    NDC 54973-3282-1
    HOMEOPATHIC

    Ages
    2-12

    SINCE 1903
    Hyland's
    4Kids
    Cold 'n Cough*

    Day & Night Combo Pack

    DAYTIME

    Nasal Congestion
    Runny Nose
    Sore Throat
    Sneezing
    Cough

    Natural Grape
    Flavor

    ALCOHOL FREE
    SUGAR FREE
    DYE FREE

    8 FL. OZ. (236 mL) Daytime

    NIGHTTIME

    Chest Congestion
    Occasional Sleeplessness
    Runny Nose
    Sore Throat
    Sneezing
    Cough

    Natural Grape
    Flavor

    ALCOHOL FREE
    SUGAR FREE
    DYE FREE

    4 FL. OZ. (118 mL) Nighttime

    12 FL. OZ. (354 mL) TOTAL

    Principal Display Panel - Kit Carton
    Close
  • INGREDIENTS AND APPEARANCE
    4 KIDS COLD N COUGH DAY AND NIGHT COMBO PACK 
    onion, calcium sulfide, goldenseal, sodium chloride, phosphorus, anemone pulsatilla, sulfur, matricaria recutita, arabica coffee bean, and strychnos nux-vomica seed kit
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3282
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54973-3282-1 1 in 1 CARTON 06/17/2016
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 1 BOTTLE, PLASTIC 236 mL
    Part 2 1 BOTTLE, PLASTIC 118 mL
    Part 1 of 2
    4 KIDS COLD N COUGH GRAPE FLAVOR 
    onion, calcium sulfide, goldenseal, sodium chloride, phosphorus, anemone pulsatilla, and sulfur liquid
    Product Information
    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)  
    LICORICE (UNII: 61ZBX54883)  
    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:54973-3243-2 236 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
    Part 2 of 2
    4KIDS COLD N COUGH NIGHTTIME GRAPE FLAVOR 
    onion, matricaria recutita, arabica coffee bean, calcium sulfide, goldenseal, sodium chloride, strychnos nux-vomica seed, phosphorus, anemone pulsatilla, and sulfur liquid
    Product Information
    Item Code (Source) NDC:54973-3245
    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
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA 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
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) 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
    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)  
    LICORICE (UNII: 61ZBX54883)  
    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:54973-3245-1 118 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 04/18/2016
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED HOMEOPATHIC 06/17/2016
    Labeler - Hyland's (028570695)
    Establishment
    Name Address ID/FEI Business Operations
    Standard Homeopathic Company 008316655 MANUFACTURE(54973-3282) , PACK(54973-3282)
    Establishment
    Name Address ID/FEI Business Operations
    Applied Laboratories, Inc. 876754375 MANUFACTURE(54973-3282) , PACK(54973-3282)
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