Label: 4 KIDS COLD N COUGH GRAPE FLAVOR- onion, calcium sulfide, goldenseal, sodium chloride, phosphorus, anemone pulsatilla, and sulfur liquid

  • NDC Code(s): 54973-3243-1, 54973-3243-2, 54973-3243-3, 54973-3243-4
  • 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 5, 2019

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

  • Drug Facts

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

    • watery/runny nose, cold, hacking cough, painful throat
    • cold, sneezing
    • rattling/tickling cough, sinus congestion, dry/raw/sore throat
    • dry cough, sore throat
    • hoarse/dry cough, nasal congestion, chest congestion
    • moist cough, cold, post nasal drip
    • chest congestion, nasal congestion, sneezing, runny nose

    Uses

    • Temporarily relieves the symptoms of common cold in children, including:
    • runny nose 
    • sore throat 
    • sneezing
    • cough 
    • post nasal drip
    • 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 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.

    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.

    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

    • 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)

    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, Natural Grape Flavoring, Purified Water, Sodium Benzoate.

    Questions or comments?

    (800) 624-9659

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

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

  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

    NDC 54973-3243-1
    HOMEOPATHIC

    Ages 2-12

    NATURAL

    RELIEF

    SINCE 1903
    Hyland's
    4Kids

    Cold 'n
    Cough*

    DAYTIME

    Natural Grape Flavor

    Congestion

    Runny Nose

    Sore Throat

    Sneezing

    Cough

    + also reliieves

    Post Nasal Drip

    ALCOHOL FREE

    SUGAR FREE
    DYE FREE

    4 FL. OZ. (118 mL)

    *SEE NOTE ON SIDE PANEL BELOW DRUG FACTS

    carton

  • INGREDIENTS AND APPEARANCE
    4 KIDS COLD N COUGH GRAPE FLAVOR 
    onion, calcium sulfide, goldenseal, sodium chloride, phosphorus, anemone pulsatilla, and sulfur liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3243
    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
    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
    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
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPE (Natural Grape Flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-3243-11 in 1 CARTON02/10/2016
    1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:54973-3243-21 in 1 CARTON02/10/2016
    2236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:54973-3243-35 mL in 1 POUCH; Type 0: Not a Combination Product02/10/2016
    4NDC:54973-3243-41 in 1 CARTON02/10/2016
    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 homeopathic02/10/2016
    Labeler - Hyland's (028570695)
    Establishment
    NameAddressID/FEIBusiness Operations
    Standard Homeopathic Company008316655manufacture(54973-3243) , pack(54973-3243)
    Establishment
    NameAddressID/FEIBusiness Operations
    Applied Laboratories, Inc.876754375manufacture(54973-3243) , pack(54973-3243)