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

  • NDC Code(s): 54973-3243-1, 54973-3377-1, 54973-3379-1
  • Packager: Hyland's 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 November 5, 2018

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

  • DAYTIME

    Drug Facts

    Active ingredients

    Allium Cepa 6X HPUS

    Hepar Sulph Calc 12X HPUS

    Hydrastis 6X HPUS

    Natrum Muriaticum 6X HPUS

    Phosphorus 12X HPUS

    Pulsatilla 6X HPUS

    Sulphur 12X HPUS

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

    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

    Uses

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

    Do not use if imprinted tamper-evident bottle cap 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.

    Drug Facts (continued)

    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 tsp up to

    6 times per day (every 4 hours)

    Children 6 years

    to under 12 years

    10 mL or 2 tsp up to

    6 times per day (every 4 hours)

    Adults and children

    12 years and over

    15 mL or 3 tsp up to

    6 times per day (every 4 hours)

    Inactive ingredients

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

    Close
  • NIGHTTIME

    Drug Facts

    Active ingredients

    Allium Cepa 6X HPUS

    Chamomilla 6X HPUS

    Coffea Cruda 6X HPUS

    Hepar Sulph Calc 12X HPUS

    Hydrastis 6X HPUS

    Natrum Muriaticum 6X HPUS

    Phosphorus 12X HPUS

    Pulsatilla 6X HPUS

    Sulphur 12X HPUS

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

    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, nasal congestion

    Sulphur 12X HPUS .........................chest congestion, nasal congestion, sneezing, runny nose

    Uses

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

    Warnings

    As with any drug, ask a doctor before use if pregnant or breast-feeding.

    Drug Facts (continued)

    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.

    Do not use if imprinted tamper-evident bottle cap 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.

    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 tsp at bedtime

    and every 4 hours during the

    night or as necessary

    Children 6 years

    to under 12 years

    10 mL or 2 tsp at bedtime

    and every 4 hours during the

    night or as necessary

    Adults and children

    12 years and over

    15 mL or 3 tsp 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

    Close
  • PRINCIPAL DISPLAY PANEL - KIT CARTON

    NDC 54973-3379-1

    HOMEOPATHIC

    Ages

    2-12

    NATURAL

    RELIEF

    SINCE 1903

    Hyland's

    4 Kids

    Cold 'n Cough*

    Natural Grape Flavor

    Day & Night Value Pack

    DAYTIME

    Congestion

    Runny Nose

    Sore Throat

    Sneezing

    Cough

    ALCOHOL FREE

    SUGAR FREE

    DYE FREE

    4 FL. OZ. (118 mL) Daytime

    NIGHTTIME

    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

    Kit Carton

    Close
  • INGREDIENTS AND APPEARANCE
    4 KIDS COLD AND COUGH DAY AND NIGHT GRAPE FLAVOR 
    onion,anemone pulsatilla, phosphorus, goldenseal, calcium sulfide, sodium chloride, sulfur, matricaria chamomilla and arabica coffee bean kit
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3379
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54973-3379-1 1 in 1 CARTON; Type 0: Not a Combination Product 12/01/2018
    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
    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
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL 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
    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
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor GRAPE Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54973-3243-1 118 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 02/10/2016
    Part 2 of 2
    4 KIDS COLD AND COUGH NIGHTTIME NATURAL GRAPE FLAVOR 
    onion,anemone pulsatilla, phosphorus, goldenseal, calcium sulfide, sodium chloride, sulfur, matricaria chamomilla and arabica coffee bean liquid
    Product Information
    Item Code (Source) NDC:54973-3377
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    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
    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
    MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA 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
    ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION 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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor GRAPE Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54973-3377-1 118 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 11/01/2018
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 12/01/2018
    Labeler - Hyland's Inc. (028570695)
    Establishment
    Name Address ID/FEI Business Operations
    Standard Homeopathic Company 008316655 manufacture(54973-3379)
    Establishment
    Name Address ID/FEI Business Operations
    Applied Laboratories, Inc 876754375 manufacture(54973-3379) , pack(54973-3379) , label(54973-3379)
    Close