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 kit

  • 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

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    "HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
    Allium Cepa 6X HPUSwatery/runny nose, cold, hacking cough, painful throat
    Hepar Sulph Calc 12X HPUScold, sneezing
    Hydrastis 6X HPUSrattling/tickling cough, sinus congestion, dry/raw/sore throat
    Natrum Muriaticum 6X HPUSdry cough, sore throat
    Phosphorus 12X HPUShoarse/dry cough, nasal congestion, chest congestion
    Pulsatilla 6X HPUSmoist cough, cold, nasal congestion
    Sulphur 12X HPUSchest congestion, nasal congestion, sneezing, runny nose
  • Uses

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

  • 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.

  • 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 years5 mL or 1 teaspoon up to 6 times per day (every 4 hours)
    Children 6 years to under 12 years10 mL or 2 teaspoons up to 6 times per day (every 4 hours)
    Adults and children 12 years and over15 mL or 3 teaspoons up to 6 times per day (every 4 hours)
  • Inactive ingredients

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

  • SPL UNCLASSIFIED SECTION

    NIGHTTIME

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    "HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
    Allium Cepa 6X HPUSwatery/runny nose, cold, hacking cough, painful throat
    Chamomilla 6X HPUSsensitive, irritable, fussy, nocturnal occasional sleeplessness
    Coffea Cruda 6X HPUSoccasional sleeplessness, restlessness
    Hepar Sulph Calc 12X HPUScold, sneezing
    Hydrastis 6X HPUSrattling/tickling cough, sinus congestion, dry/raw/sore throat
    Natrum Muriaticum 6X HPUSdry cough, sore throat
    Nux Vomica 6X HPUS
    (0.0000016% Alkaloids, calculated)
    tired, difficulty falling asleep, frequent waking
    Phosphorus 12X HPUShoarse/dry cough, nasal congestion, chest congestion
    Pulsatilla 6X HPUSmoist cough, cold, nasal congestion
    Sulphur 12X HPUSchest congestion, nasal congestion, sneezing, runny nose
  • 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.

  • 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.

  • 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 years5 mL or 1 teaspoon at bedtime and every 4 hours during the night or as necessary
    Children 6 years to under 12 years10 mL or 2 teaspoons at bedtime and every 4 hours during the night or as necessary
    Adults and children 12 years and over15 mL or 3 teaspoons at bedtime and every 4 hours during the night or as necessary
  • Inactive ingredients

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

  • Questions or comments?

    (800) 624-9659

  • 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
  • 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3282
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-3282-11 in 1 CARTON06/17/2016
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, PLASTIC 236 mL
    Part 21 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 AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION6 [hp_X]  in 1 mL
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE12 [hp_X]  in 1 mL
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL6 [hp_X]  in 1 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE6 [hp_X]  in 1 mL
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS12 [hp_X]  in 1 mL
    ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA6 [hp_X]  in 1 mL
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR12 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LICORICE (UNII: 61ZBX54883)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPE (Natural Grape Flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-3243-2236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC02/10/2016
    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 AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION6 [hp_X]  in 1 mL
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA6 [hp_X]  in 1 mL
    ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN6 [hp_X]  in 1 mL
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE12 [hp_X]  in 1 mL
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL6 [hp_X]  in 1 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE6 [hp_X]  in 1 mL
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED6 [hp_X]  in 1 mL
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS12 [hp_X]  in 1 mL
    ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA6 [hp_X]  in 1 mL
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR12 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LICORICE (UNII: 61ZBX54883)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPE (Natural Grape Flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-3245-1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC04/18/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC06/17/2016
    Labeler - Hyland's (028570695)
    Establishment
    NameAddressID/FEIBusiness Operations
    Standard Homeopathic Company008316655MANUFACTURE(54973-3282) , PACK(54973-3282)
    Establishment
    NameAddressID/FEIBusiness Operations
    Applied Laboratories, Inc.876754375MANUFACTURE(54973-3282) , PACK(54973-3282)