Label: 4 KIDS COLD AND COUGH NIGHTTIME NATURAL GRAPE FLAVOR- onion,anemone pulsatilla, phosphorus, goldenseal, calcium sulfide, sodium chloride, sulfur, matricaria chamomilla and arabica coffee bean liquid

  • NDC Code(s): 54973-3377-1, 54973-3377-2, 54973-3377-3
  • 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 June 22, 2023

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  • PURPOSE

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

  • Drug Facts

    Active ingredients

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

    Chamomilla 6X HPUS ......... sensitive, irritable, fussy, nocturnal occasional sleeplessness

    Coffea Cruda 6X HPUS........occasional sleeplessness, restlessness

    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

  • 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 at bedtime and every 4 hours
    during the night until relieved.
    Children 6 years
    to under 12 years     		10 mL at bedtime and every 4 hours
    during the night until relieved.
    Adults and children
    12 years and over     		15 mL at bedtime and every 4 hours
    during the night until relieved.

  • Inactive ingredients

    Citric Acid, Glycerine, Glycyrrhiza Extract,Natural Grape Flavor Purified Water, Sodium Benzoate.

  • Questions?

    www.hylands.com or care@hylands.com

  • 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.

  • Uses

    ■ Helps temporarily relieve symptoms of common cold in children at night, including:

    ■ cough ■ runny nose ■ post nasal drip ■ sneezing ■ sore throat

    ■ nasal or chest congestion ■ occasional sleeplessness

  • PRINCIPAL DISPLAY PANEL

    Hyland's

    NATURALS™

    •Kids•

    Cold & Cough

    NIGHTTIME

    NO ALCOHOL, SUGAR,

    PARABENS or DYES*

    Sleeplessness

    Congestion

    Runny Nose

    Sore Throat

    Cough

    Post Nasal

    Drip

    2-12

    YEARS

    NATURAL

    GRAPE FLAVOR

    4 FL. OZ. (118 mL)

    HOMEOPATHIC

    Carton

    label

  • PRINCIPAL DISPLAY PANEL

    NDC 54973-3377-3 5 FL. OZ. (148 mL)

    2

    label

  • INGREDIENTS AND APPEARANCE
    4 KIDS COLD AND COUGH NIGHTTIME NATURAL GRAPE FLAVOR 
    onion,anemone pulsatilla, phosphorus, goldenseal, calcium sulfide, sodium chloride, sulfur, matricaria chamomilla and arabica coffee bean liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3377
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE6 [hp_X]  in 1 mL
    ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION6 [hp_X]  in 1 mL
    MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA6 [hp_X]  in 1 mL
    ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN6 [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
    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)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-3377-11 in 1 CARTON11/01/2018
    1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:54973-3377-25 mL in 1 PACKET; Type 0: Not a Combination Product11/01/201812/15/2021
    3NDC:54973-3377-31 in 1 CARTON11/01/2018
    3148 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/01/2018
    Labeler - Hyland's Inc. (008316655)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hyland's Inc.008316655manufacture(54973-3377) , pack(54973-3377) , label(54973-3377)
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