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 November 1, 2021

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

  • PURPOSE

    Relieves congestion, runny nose, sore throat, sneezing, cough and post nasal drip

  • Drug Facts

    Active ingredients

    Allium Cepa 6X HPUS ................... watery/runny nose,cold, hacking cough, painful throat

    Hepar Sulph Calc 12X HPUS.................cold, sneezing

    Hydrastis 6X HPUS ..................rattling/tickling cough, sinus congestion, dry/raw/sore throat

    Natrum Muriaticum 6X HPUS .................... dry cough, sore throat

    Phosphorus 12X HPUS...................hoarse/dry cough, nasal congestion, chest congestion

    Pulsatilla 6X HPUS.........................moist cough, cold, post nasal drip

    Sulphur 12X HPUS ......................... chest congestion, nasal congestion, sneezing, runny nose

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

  • Uses

    ■ Temporarily relieves 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.

    As with any drug, ask a doctor before use if pregnant or breast-feeding.

    Keep this and all medications out of the 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, Natural Grape Flavoring, 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.

  • OTHER SAFETY INFORMATION

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

  • PACKAGE LABEL-PRINCIPAL 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

    NATURAL

    GRAPE FLAVOR

    4 FL. OZ. (118 mL)

    HOMEOPATHIC

    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)
    Registrant - Standard Homeopathic Company (Hyland's) (008316655)
    Establishment
    NameAddressID/FEIBusiness Operations
    Standard Homeopathic Company008316655manufacture(54973-3243) , pack(54973-3243)
    Establishment
    NameAddressID/FEIBusiness Operations
    Standard Homeopathic Company080253323manufacture(54973-3243) , pack(54973-3243) , label(54973-3243)
    Establishment
    NameAddressID/FEIBusiness Operations
    Applied Laboratories, Inc.876754375manufacture(54973-3243) , pack(54973-3243)