Label: 4KIDS COLD N MUCUS NIGHTTIME- onion, bryonia alba root, matricaria recutita, arabica coffee bean, euphrasia stricta, calcium sulfide, goldenseal, sodium chloride, strychnos nux-vomica seed, phosphorus, anemone pulsatilla, rumex crispus root, silicon dioxide, and sulfur liquid

  • NDC Code(s): 54973-3250-1, 54973-3250-2
  • 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 December 12, 2017

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

    Active ingredientsPurpose
    Allium Cepa 6X HPUSrunny nose with mucus, hacking cough, sore throat
    Bryonia Alba 6X HPUSstubborn mucus in throat,cough with yellowish mucus
    Chamomilla 3X HPUSirritability, fussiness, occasional sleeplessness
    Coffea Cruda 3X HPUSoccasional sleeplessness, restlessness
    Euphrasia Officinalis 6X HPUScough with mucus in chest
    Hepar Sulph Calc 12X HPUScough up mucus, mucus rattle with cough, stubborn mucus in chest
    Hydrastis 6X HPUScough with mucus, dry, sore throat, occasional sleeplessness due to mucus in throat
    Natrum Muriaticum 6X HPUSaccumulation of mucus in throat, cough up mucus
    Nux Vomica 6X HPUS
    (0.0000016% Alkaloids, calculated)
    tired, difficulty falling asleep, frequent waking
    Phosphorus 30X HPUScough with expectoration of yellow mucus, chest congestion
    Pulsatilla 6X HPUSaccumulation of mucus, discharge of thick yellowish mucus, loose cough
    Rumex Crispus 6X HPUSrunny nose, sneezing
    Silicea 12X HPUSnasal congestion
    Sulphur 12X HPUScough with thick mucus, chest congestion, nasal congestion

    "HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopœia of the United States.

  • 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.

  • 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 preprinted tamper band is broken or missing.

  • Drug Facts (continued)

  • SPL UNCLASSIFIED SECTION

    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, Purified Water, Sodium Benzoate.

  • Questions or comments?

    (800) 624-9659

  • PURPOSE

    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.

  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

    NDC 54973-3250-1

    HOMEOPATHIC

    Natural

    Relief

    Ages

    2-12

    SINCE 1903

    Hyland's ®

    4Kids

    Cold 'n
    Mucus *

    NIGHTTIME

    Loosens mucus in
    chest, throat and nose

    Mucus & Congestion

    Occasional Sleeplessness

    Runny Nose

    Cough

    LESS THAN 0.2% ALCOHOL
    SUGAR FREE
    DYE FREE

    SAFE &
    EFFECTIVE

    4 FL. OZ. (118 mL)

    carton

  • INGREDIENTS AND APPEARANCE
    4KIDS COLD N MUCUS NIGHTTIME 
    onion, bryonia alba root, matricaria recutita, arabica coffee bean, euphrasia stricta, calcium sulfide, goldenseal, sodium chloride, strychnos nux-vomica seed, phosphorus, anemone pulsatilla, rumex crispus root, silicon dioxide, and sulfur liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3250
    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
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA3 [hp_X]  in 1 mL
    ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN3 [hp_X]  in 1 mL
    EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA6 [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) PHOSPHORUS30 [hp_X]  in 1 mL
    ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA6 [hp_X]  in 1 mL
    RUMEX CRISPUS ROOT (UNII: 9N1RM2S62C) (RUMEX CRISPUS ROOT - UNII:9N1RM2S62C) RUMEX CRISPUS ROOT6 [hp_X]  in 1 mL
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE12 [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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-3250-11 in 1 CARTON04/29/2016
    1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:54973-3250-25 mL in 1 POUCH; Type 0: Not a Combination Product11/11/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/29/2016
    Labeler - Hyland's (028570695)
    Establishment
    NameAddressID/FEIBusiness Operations
    Standard Homeopathic Company008316655manufacture(54973-3250) , pack(54973-3250)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nexgen Pharma, Inc.079424083manufacture(54973-3250) , pack(54973-3250)
    Establishment
    NameAddressID/FEIBusiness Operations
    Applied Laboratories, Inc.117337220pack(54973-3250)