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

  • NDC Code(s): 54973-3075-1, 54973-3375-1, 54973-3378-1
  • Packager: Hyland’s Inc.
  • Category: HUMAN OTC DRUG LABEL

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 27, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • DAYTIME

    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.

  • NIGHTTIME

    Drug Facts

    Active ingredientsPurpose*
    Allium Cepa 6X HPUSwatery/runny nose, cold, hacking cough, painful throat
    Chamomilla 6X HPUSoccasional sleeplessness
    Coffea Cruda 6X HPUSoccasional sleeplessness
    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 at night, including:
    ■ cough ■ runny nose ■ post nasal drip ■ sneezing ■ sore throat
    ■ nasal or chest congestion ■ 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?

    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 at night, including: cough, runny nose, post nasal drip, sneezing, sore throat, nasal or chest congestion, occasional sleeplessness.

  • Principal Display Panel - Kids Cold & Cough Daytime Nighttime Combo Pack

    Hyland's

    NATURALS™

    •baby•

    Cold & Cough*

    COMBO BACK

    NO ALCOHOL, SUGAR, PARABENS or DYES

    DAYTIME

    Congestion*

    Runny Nose*

    Sore Throat*

    Cough*

    Post Nasal

    Drip*

    NIGHTTIME

    Sleeplessness*

    Congestion*

    Runny Nose*

    Sore Throat*

    Cough*

    Post Nasal

    Drip*

    2 - 12 YEARS

    TWP - 4 FL. OZ. (118 mL) Bottles (1 Day, 1 Night)

    HOMEOPATHIC

    carton

  • INGREDIENTS AND APPEARANCE
    4 KIDS COLD AND COUGH DAYTIME AND NIGHTTIME 
    onion, calcium sulfide, sodium chloride, anemone pulsatilla, arabica coffee bean, matricaria chamomilla, sulfur, phosphorus and goldenseal kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3378
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-3378-11 in 1 CARTON; Type 0: Not a Combination Product06/08/2018
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, PLASTIC 118 mL
    Part 21 BOTTLE, PLASTIC 118 mL
    Part 1 of 2
    COLD AND COUGH 4 KIDS 
    onion, calcium sulfide, sodium chloride, phosphorus, pulsatilla vulgaris, sulfur, and goldenseal liquid
    Product Information
    Item Code (Source)NDC:54973-3075
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE6 [hp_X]  in 1 mL
    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
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS12 [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
    ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA6 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-3075-1118 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
    Part 2 of 2
    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
    Item Code (Source)NDC:54973-3375
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN6 [hp_X]  in 1 mL
    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
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS12 [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
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR12 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-3375-11 in 1 CARTON
    1118 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
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/08/2018
    Labeler - Hyland’s Inc. (008316655)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hyland's Inc.008316655manufacture(54973-3378) , pack(54973-3378) , label(54973-3378)