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

  • NDC Code(s): 54973-3075-1, 54973-3375-1, 54973-3378-1
  • 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 September 7, 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 Pharmacopoeia 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 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 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.

    Persistent cough

    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 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 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)

    Inactive ingredients

    Citric Acid, Glycerine, Glycyrrhiza Extract, 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 Pharmacopoeia 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, and 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

    • 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 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 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

    Inactive ingredients

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

    Questions or comments?

    (800) 624-9659

    Close
  • SPL UNCLASSIFIED SECTION

    *CLAIMS BASED ON TRADITIONAL

    HOMEOPATHIC PRACTICE, NOT ACCEPTED

    MEDICAL EVIDENCE. NOT FDA EVALUATED.

    Close
  • Principal Display Panel - Kit Carton

    NDC-54973-3378-1

    HOMEOPATHIC

    NATURAL

    RELIEF

    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

    KIT CARTON

    Close
  • INGREDIENTS AND APPEARANCE
    4 KIDS COLD AND COUGH DAY AND NIGHT VALUE PACK 
    onion, calcium sulfide, sodium chloride, anemone pulsatilla, arabica coffee bean, matricaria chamomilla, sulfur, phosphorus and goldenseal kit
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3378
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54973-3378-1 1 in 1 CARTON; Type 0: Not a Combination Product 06/08/2018
    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
    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
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE 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
    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
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL 6 [hp_X]  in 1 mL
    ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA 6 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    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
    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
    Item Code (Source) NDC:54973-3375
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    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
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE 12 [hp_X]  in 1 mL
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 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
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 12 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54973-3375-1 118 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 07/01/2018
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 06/08/2018
    Labeler - Hyland’s (028570695)
    Establishment
    Name Address ID/FEI Business Operations
    Nexgen Pharma, Inc. 079424083 manufacture(54973-3378) , pack(54973-3378) , label(54973-3378)
    Establishment
    Name Address ID/FEI Business Operations
    Applied Laboratories, Inc. 876754375 manufacture(54973-3378) , pack(54973-3378) , label(54973-3378)
    Close