Label: COLD AND COUGH 4 KIDS- onion, calcium sulfide, sodium chloride, phosphorus, pulsatilla vulgaris, sulfur, and goldenseal liquid

  • NDC Code(s): 54973-3075-1, 54973-3075-2
  • 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 July 31, 2023

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  • Drug Facts

    Active ingredientsPurpose*
    Allium Cepa 6X HPUSwatery/runny nose, cold, hacking cough, painful throat
    Hepar Sulph Calc 12X HPUScold, sneezing
    Hydrastis 6X HPUSrattling/tickling cough, sinus congestion, dry/raw/sore throat
    Natrum Muriaticum 6X HPUSdry cough, sore throat
    Phosphorus 12X HPUShoarse/dry cough, nasal congestion, chest congestion
    Pulsatilla 6X HPUSmoist cough, cold, post nasal drip
    Sulphur 12X HPUSchest congestion, nasal congestion, sneezing, runny nose

    "HPUS" is the Homeopathic Pharmacopoeia of the United States.

  • Uses*

    ■ Helps temporarily relieve symptoms of common cold in children, including:
    ■ runny nose ■ sore throat ■ sneezing ■ cough
    ■ post nasal drip ■ nasal or chest congestion

  • Warnings

    Sore throat warning

    If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

    Ask a doctor before use if you have

    ■ persistent or chronic cough such as smoking, asthma, chronic bronchitis or emphysema. A persistent cough may be a sign of a serious condition. ■ cough that is accompanied by excessive phlegm (mucus).

    Stop use and ask a doctor if

    ■ symptoms persist for more than 7 days or worsen. ■ inflammation, fever or infection is present or develops. ■ cough tends to recur or is accompanied by a fever, rash or persistent headache.

    If pregnant or breastfeeding

    Ask a health professional before use.

    Keep out of reach of children

  • Directions

    ■ Use as directed. ■ Do not refrigerate. ■ Shake well before using. ■ Measure only with the dosing cup provided. ■ Do not use
    dosing cup with other products. ■ On dosing cup, mL = milliliter.

    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).

  • Inactive ingredients

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

  • Questions?

    www.hylands.com or care@hylands.com

  • *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

  • DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING.

  • PURPOSE

    Helps temporarily relieve symptoms of common cold in children, including: runny nose, sore throat, sneezing, cough, post nasal drip, nasal or chest congestion.

  • Packaging Display Panel

    Hyland's

    NATURALS

    •Kids•

    Cold &

    Cough*

    DAYTIME

    NO ALCOHOL, SUGAR,

    PARABENS or DYES

    Congestion*

    Runny Nose*

    Sore Throat*

    Cough*

    Post Nasal
    Drip*

    2 -12

    YEARS

    4 FL. OZ.

    HOMEOPATHIC

    carton

  • INGREDIENTS AND APPEARANCE
    COLD AND COUGH 4 KIDS 
    onion, calcium sulfide, sodium chloride, phosphorus, pulsatilla vulgaris, sulfur, and goldenseal liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3075
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION6 [hp_X]  in 1 mL
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE12 [hp_X]  in 1 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE6 [hp_X]  in 1 mL
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS12 [hp_X]  in 1 mL
    ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA6 [hp_X]  in 1 mL
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR12 [hp_X]  in 1 mL
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL6 [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:54973-3075-1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2008
    2NDC:54973-3075-21 in 1 CARTON08/01/200812/28/2021
    219.8 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/01/2008
    Labeler - Hyland's Inc. (008316655)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hyland's Inc.008316655manufacture(54973-3075) , pack(54973-3075) , label(54973-3075)
    Establishment
    NameAddressID/FEIBusiness Operations
    Applied Laboratories, Inc.117337220manufacture(54973-3075) , pack(54973-3075)
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