Label: 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

  • NDC Code(s): 54973-3179-1, 54973-3179-2, 54973-3179-4, 54973-3179-5
  • Packager: Hyland's Inc.
  • Category: HUMAN OTC DRUG LABEL

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 21, 2022

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • PURPOSE

    Relieves mucus, congestion, cough, runny nose and sneezing

  • Drug Facts

    Active ingredientsPurpose
    Bryonia 6X HPUSstubborn mucus in throat, cough with yellowish mucus
    Euphrasia Officinalis 6X HPUScough with mucus in chest
    Hepar Sulph Calc 12X HPUScough up mucus, mucus rattle with cough, stubborn mucus in chest
    Natrum Muriaticum 30X HPUSaccumulation of mucus in throat, cough up mucus
    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

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

    Uses

    ■Temporarily relieves symptoms of common cold in children, including: ■ accumulation of mucus in chest, throat or nose

    ■ cough with expectoration of thick, discolored mucus

    ■ runny nose ■ sneezing ■ nasal or chest 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.

    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.

    In case of emergency or accidental overdose, 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 up to 6 times per day (every 4 hours).
    children 6 years to under 12 years

    10 mL up to 6 times per day (every 4 hours).
    adults and children 12 years and over

    15 mL up to 6 times per day (every 4 hours).

    Other information

    ■ Do not use if imprinted "SEALED FOR YOUR PROTECTION" tamper-evident bottle cap band is broken or missing.

    ■ The inner packaged bottle is child-resistant.

    ■ Store at room temperature.

    ■ Do not refrigerate.

    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 - 118 mL Bottle Carton

    HOMEOPATHIC

    NDC 54973-3179-1


    2-12

    YEARS

    New
    Look

    4 Kids

    SINCE 1903
    Hyland's®

    DAYTIME

    Cold &
    Mucus     *

    Relieves mucus,

    congestion, cough,

    runny nose and sneezing

    NO ALCOHOL or PARABENS

    NO SUGAR or DYES

    NATURAL

    RELIEF

    4 FL. OZ. (118 mL)

    *SEE NOTE

    ON SIDE PANEL

    BELOW DRUG FACTS

    carton

  • INGREDIENTS AND APPEARANCE
    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
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3179
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    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
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE12 [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
    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
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-3179-11 in 1 CARTON07/01/2014
    1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:54973-3179-21 in 1 CARTON10/17/201412/15/2021
    219.8 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:54973-3179-410 in 1 CARTON07/01/201412/15/2021
    35 mL in 1 POUCH; Type 0: Not a Combination Product
    4NDC:54973-3179-51 in 1 CARTON07/01/2014
    4148 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
    Labeler - Hyland's Inc. (008316655)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hyland's Inc.008316655manufacture(54973-3179) , pack(54973-3179) , label(54973-3179)
    Establishment
    NameAddressID/FEIBusiness Operations
    Applied Laboratories, Inc.117337220pack(54973-3179)
    Establishment
    NameAddressID/FEIBusiness Operations
    LGM Pharma Solutions, LLC117549198manufacture(54973-3179) , pack(54973-3179) , label(54973-3179)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!