Label: 4 KIDS COLD AND MUCUS- euphrasia stricta,silicon dioxide, rumex crispus root, anemone pulsatilla, goldenseal, sodium chloride, phosphorus, onion, bryonia alba root, matricaria chamomilla, arabica coffee bean, calcium sulfide and sulfur kit

  • NDC Code(s): 54973-3179-1, 54973-3372-2, 54973-3381-1
  • 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 August 2, 2018

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

  • DAYTIME

    Drug Facts

    Active ingredients

    Bryonia Alba 6X HPUS

    Euphrasia Officinalis 6X HPUS

    Hepar Sulph Calc 12X HPUS

    Natrum Muriaticum 30X HPUS

    Phosphorus 30X HPUS

    Pulsatilla 6X HPUS

    Rumex Crispus 6X HPUS

    Silicea 12X HPUS

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

    Bryonia Alba 6X HPUS...stubborn mucus in throat, cough with yellowish mucus

    Euphrasia Officinalis 6X HPUS...cough with mucus in chest

    Hepar Sulph Calc 12X HPUS......cough up mucus, mucus rattle with cough, stubborn mucus in chest

    Natrum Muriaticum 30X HPUS.....accumulation of mucus in throat, cough up mucus

    Phosphorus 30X HPUS.........cough with expectoration of yellow mucus, chest congestion

    Pulsatilla 6X HPUS...accumulation of mucus, discharge of thick yellowish mucus, loose cough

    Rumex Crispus 6X HPUS.................runny nose, sneezing

    Silicea 12X HPUS...................................nasal congestion

    Uses

    Temporarily relieves symptoms of colds, including accumulation of mucus in chest, throat and nose; cough with expectoration of thick, discolored mucus; runny nose, sneezing and nasal congestion.

    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 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.

  • NIGHTTIME

    Active ingredients

    Allium Cepa 6X HPUS

    Bryonia Alba 6X HPUS

    Chamomilla 3X HPUS

    Coffea Cruda 3X HPUS

    Euphrasia Officinalis 6X HPUS

    Hepar Sulph Calc 12X HPUS

    Hydrastis 6X HPUS

    Natrum Muriaticum 6X HPUS

    Phosphorus 30X HPUS

    Pulsatilla 6X HPUS

    Rumex Crispus 6X HPUS

    Silicea 12X HPUS

    Sulphur 12X HPUS

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

    Allium Cepa 6X HPUS..................runny nose with mucus, hacking cough, sore throat

    Bryonia Alba 6X HPUS...stubborn mucus in throat, cough with yellowish mucus

    Chamomilla 3X HPUS.....irritability, fussiness, occasional sleeplessness

    Coffea Cruda 3X HPUS.............occasional sleeplessness, restlessness

    Euphrasia Officinalis 6X HPUS...cough with mucus in chest

    Hepar Sulph Calc 12X HPUS......cough up mucus, mucus rattle with cough, stubborn mucus in chest

    Hydrastis 6X HPUS...cough with mucus, dry, sore throat, occasional sleeplessness due to mucus in throat

    Natrum Muriaticum 6X HPUS...accumulation of mucus in throat, cough up mucus

    Phosphorus 30X HPUS.........cough with expectoration of yellow mucus, chest congestion

    Pulsatilla 6X HPUS...accumulation of mucus, discharge of thick yellowish mucus, loose cough

    Rumex Crispus 6X HPUS.................runny nose, sneezing

    Silicea 12X HPUS...................................nasal congestion

    Sulphur 12X HPUS............cough with thick mucus, chest congestion, nasal congestion

    Uses

    Temporarily relieves the symptoms of the common cold in children especially at night including accumulation of mucus in chest, throat and nose, cough with mucus, runny nose, sneezing, nasal congestion and occasional sleeplessness.

    Drug Facts (continued)

    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 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

  • SPL UNCLASSIFIED SECTION

    *CLAIMS BASED ON TRADITIONAL

    HOMEOPATHIC PRACTICE, NOT ACCEPTED

    MEDICAL EVIDENCE. NOT FDA EVALUATED.

  • Principal Display Panel - Kit Carton

    NDC 54973-3381-1

    HOMEOPATHIC

    Ages

    2-12

    NATURAL

    RELIEF

    SINCE 1903

    Hyland's

    4 Kids

    Cold'n Mucus*

    Loosens mucus in chest, throat and nose

    Day & Night Value Pack

    DAYTIME

    Mucus & Congestion

    Runny Nose

    Cough

    ALCOHOL FREE

    SUGAR FREE

    DYE FREE

    4 FL. OZ. (118 mL) Daytime

    NIGHTTIME

    Mucus & Congestion

    Occasional Sleeplessness

    Runny Nose

    Cough

    LESS THAN 0.2% ALCOHOL

    SUGAR FREE

    DYE FREE

    4 FL. OZ. (118 mL) Nighttime

    8 FL. OZ. (236 mL) TOTAL

    KIT CARTON

  • INGREDIENTS AND APPEARANCE
    4 KIDS COLD AND MUCUS 
    euphrasia stricta,silicon dioxide, rumex crispus root, anemone pulsatilla, goldenseal, sodium chloride, phosphorus, onion, bryonia alba root, matricaria chamomilla, arabica coffee bean, calcium sulfide and sulfur kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3381
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-3381-11 in 1 CARTON08/01/2018
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, PLASTIC 118 mL
    Part 21 BOTTLE, PLASTIC 118 mL
    Part 1 of 2
    4 KIDS COLD AND MUCUS NIGHTTIME 
    euphrasia stricta,silicon dioxide, rumex crispus root, anemone pulsatilla, goldenseal, sodium chloride, phosphorus, onion, bryonia alba root, matricaria chamomilla, arabica coffee bean, calcium sulfide and sulfur liquid
    Product Information
    Item Code (Source)NDC:54973-3372
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION6 [hp_X]  in 1 mL
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT6 [hp_X]  in 1 mL
    EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA6 [hp_X]  in 1 mL
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL6 [hp_X]  in 1 mL
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS30 [hp_X]  in 1 mL
    ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN3 [hp_X]  in 1 mL
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE12 [hp_X]  in 1 mL
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE12 [hp_X]  in 1 mL
    ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA6 [hp_X]  in 1 mL
    MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA3 [hp_X]  in 1 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE6 [hp_X]  in 1 mL
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR12 [hp_X]  in 1 mL
    RUMEX CRISPUS ROOT (UNII: 9N1RM2S62C) (RUMEX CRISPUS ROOT - UNII:9N1RM2S62C) RUMEX CRISPUS ROOT6 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-3372-2118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/27/2018
    Part 2 of 2
    4 KIDS COMPLETE COLD AND MUCUS 
    bryonia alba root, euphrasia stricta, calcium sulfide, sodium chloride, phosphorus, anemone pulsatilla, rumex crispus root, and silicon dioxide liquid
    Product Information
    Item Code (Source)NDC:54973-3179
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    RUMEX CRISPUS ROOT (UNII: 9N1RM2S62C) (RUMEX CRISPUS ROOT - UNII:9N1RM2S62C) RUMEX CRISPUS ROOT6 [hp_X]  in 1 mL
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE12 [hp_X]  in 1 mL
    EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA6 [hp_X]  in 1 mL
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT6 [hp_X]  in 1 mL
    ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA6 [hp_X]  in 1 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE30 [hp_X]  in 1 mL
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS30 [hp_X]  in 1 mL
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE12 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-3179-1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/01/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/01/2018
    Labeler - Hyland's (028570695)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nexgen Pharma, Inc.079424083manufacture(54973-3381) , pack(54973-3381) , label(54973-3381)
    Establishment
    NameAddressID/FEIBusiness Operations
    Applied Laboratories, Inc.876754375manufacture(54973-3381) , pack(54973-3381) , label(54973-3381)