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
  • 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.

  • DAYTIME

    Drug Facts

    Active ingredients

    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 that the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.

    Purpose

    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, nasal congestion

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

    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).

    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 ingredients

    Allium Cepa 6X HPUS

    Chamomilla 6X HPUS

    Coffea Cruda 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 that the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.

    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, nasal congestion

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

    Uses

    ■ 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.

    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?

    (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 - KIT CARTON

    Hyland's

    NATURALS™

    •Kids•

    Cold & Cough*

    COMBO PACK

    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

    TWO - 4 FL. OZ. (118 mL) Bottles (1 Day, 1 Night) | TOTAL 8 FL. OZ. (236 mL)

    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 N 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 (028570695)
    Registrant - Standard Homeopathic Company (Hyland's) (008316655)
    Establishment
    NameAddressID/FEIBusiness Operations
    Standard Homeopathic Company080253323manufacture(54973-3378) , pack(54973-3378) , label(54973-3378)
    Establishment
    NameAddressID/FEIBusiness Operations
    Applied Laboratories, Inc.876754375manufacture(54973-3378) , pack(54973-3378) , label(54973-3378)