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

  • NDC Code(s): 54973-3243-1, 54973-3377-1, 54973-3379-1
  • 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 November 3, 2021

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

  • PURPOSE

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

  • DAYTIME

    Drug Facts

    Active ingredients

    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, 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, 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, Natural Grape Flavor, Purified Water, Sodium Benzoate.

  • NIGHTTIME

    Drug Facts

    Active ingredients

    Purpose

    Allium Cepa 6X HPUS

    watery/runny nose, cold, hacking cough, painful throat

    Chamomilla 6X HPUS

    occasional sleeplessness

    Coffea Cruda 6X HPUS

    occasional sleeplessness

    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, Natural Grape Flavor, 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

    NATURAL

    GRAPE FLAVOR

    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 DAY AND NIGHT GRAPE FLAVOR 
    onion,anemone pulsatilla, phosphorus, goldenseal, calcium sulfide, sodium chloride, sulfur, matricaria chamomilla and arabica coffee bean kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3379
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-3379-11 in 1 CARTON; Type 0: Not a Combination Product12/01/2018
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, PLASTIC 118 mL
    Part 21 BOTTLE, PLASTIC 118 mL
    Part 1 of 2
    4 KIDS COLD N COUGH GRAPE FLAVOR 
    onion, calcium sulfide, goldenseal, sodium chloride, phosphorus, anemone pulsatilla, and sulfur liquid
    Product Information
    Item 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
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL6 [hp_X]  in 1 mL
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE12 [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
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-3243-11 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 homeopathic02/10/2016
    Part 2 of 2
    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
    Item Code (Source)NDC:54973-3377
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    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
    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) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE6 [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
    ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION6 [hp_X]  in 1 mL
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS12 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    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 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 homeopathic11/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic12/01/2018
    Labeler - Hyland's Inc. (028570695)
    Establishment
    NameAddressID/FEIBusiness Operations
    Standard Homeopathic Company008316655manufacture(54973-3379)
    Establishment
    NameAddressID/FEIBusiness Operations
    Standard Homeopathic Company080253323manufacture(54973-3379) , pack(54973-3379) , label(54973-3379)
    Establishment
    NameAddressID/FEIBusiness Operations
    Applied Laboratories, Inc876754375manufacture(54973-3379) , pack(54973-3379) , label(54973-3379)