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

  • NDC Code(s): 54973-3375-1, 54973-3375-2, 54973-3375-3
  • 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 2, 2021

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

  • Drug Facts

    Active ingredients

    Purpose

    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

    “HPUS” indicates that the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.

  • Uses

    ■Temporarily relieves symptoms of common cold in children at night, including:

    ■ cough ■ runny nose ■ post nasal drip

    ■ sneezing ■ nasal or chest congestion

    ■ sore throat ■ occasional sleeplessness

  • 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, 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*

    NIGHTTIME

    NO ALCOHOL, SUGAR,

    PARABENS or DYES

    Sleeplessness

    Congestion

    Runny Nose

    Sore Throat

    Cough

    Post Nasal

    Drip

    2-12

    YEARS

    4 FL. OZ. (118 mL)

    HOMEOPATHIC

    carton

  • INGREDIENTS AND APPEARANCE
    4 KIDS COLD AND COUGH NIGHTTIME 
    onion, calcium sulfide, sodium chloride, anemone pulsatilla, arabica coffee bean, matricaria chamomilla, sulfur, phosphorus and goldenseal liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3375
    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) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE6 [hp_X]  in 1 mL
    ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA6 [hp_X]  in 1 mL
    MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA6 [hp_X]  in 1 mL
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL6 [hp_X]  in 1 mL
    ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN6 [hp_X]  in 1 mL
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS12 [hp_X]  in 1 mL
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR12 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-3375-11 in 1 CARTON07/01/2018
    1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:54973-3375-25 mL in 1 PACKET; Type 0: Not a Combination Product07/01/2018
    3NDC:54973-3375-31 in 1 CARTON07/01/2018
    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 homeopathic07/01/2018
    Labeler - Hyland's (028570695)
    Registrant - Standard Homeopathic Company (Hyland's) (008316655)
    Establishment
    NameAddressID/FEIBusiness Operations
    Standard Homeopathic Company080253323manufacture(54973-3375) , pack(54973-3375) , label(54973-3375)
    Establishment
    NameAddressID/FEIBusiness Operations
    Applied Laboratories, Inc.876754375manufacture(54973-3375) , pack(54973-3375) , label(54973-3375)