4 KIDS COLD AND COUGH DAYTIME (ONION, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS, SULFUR, AND GOLDENSEAL) LIQUID [HYLAND'S]

4 KIDS COLD AND COUGH DAYTIME (ONION, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS, SULFUR, AND GOLDENSEAL) LIQUID [HYLAND'S]
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NDC 54973-3400-1
Set ID 804e0e7a-20eb-128b-e053-2991aa0aa82c
Category HUMAN OTC DRUG LABEL
Packager Hyland's
Generic Name
Product Class
Product Number
Application Number
  • Drugs 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 Pharmacopœia 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 the symptoms of the common cold including: nasal or chest congestion, runny nose, sore throat, sneezing, cough.

    Warnings

    As with any drug, ask a doctor before use if pregnant or breast-feeding.

    Consult a physician if

    • Symptoms persist for more than 7 days or worsen
    • Inflammation, fever or infection develops
    • Symptoms are accompanied by high fever (101°F).
    • Cough tends to recur or is accompanied by high fever, rash or persistent headache

    Keep this and all medications out of the reach of children

    In case of accidental overdose, contact a medical professional or Poison Control Center immediately.

    Do not use this product

    For persistent or chronic cough such as asthma, smoking or emphysema or if cough is accompanied by excessive mucus, unless directed by a licensed medical professional.

    A persistent cough may be a sign of a serious condition.

    Sore throat warning

    Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea and vomiting may be serious. Consult a doctor promptly.

    Do not use if imprinted tamper-evident bottle cap band is broken or missing.

    The inner packaged bottle is child-resistant

    In case of emergency

    contact a medical professional or Poison Control Center immediately. Hyland's may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.

  • Drug Facts(continued)

    Directions

    • Measure only with the dosing cup provided
    • Do not use dosing cup with other products
    • On dosing cup, mL = milliliter, tsp = teaspoon

    Children 2 years to

    under 6 years

    5 mL or 1 teaspoon up to 6

    times per day (every 4 hours)

    Children 6 years to

    under 12 years

    10 mL or 2 teaspoons up to 6

    times per day (every 4 hours)

    Adults and children

    12 years and over

    15 mL or 3 teaspoons up to 6

    times per day (every 4 hours)

    Inactive ingredients

    Citric Acid, Glycerine, Glycyrrhiza Extract, Purified Water, Sodium Benzoate.

    Questions or comments?

    (800) 624-9659

  • Principal Display Panel - 148 mL Bottle Carton

    25% MORE

    BONUS PACK

    NDC 54973-3400-1

    HOMEOPATHIC

    Ages

    2-12

    NATURAL

    RELIEF

    SINCE 1903

    Hyland's

    4Kiids

    Cold 'n

    Cough*

    DAYTIME

    Congestion

    Runny Nose

    Sore Throat

    Sneezing

    Cough

    ALCOHOL FREE

    SUGAR FREE

    DYE FREE

    4 + 1 = 5 S FL. OZ. (148 mL)

    Carton

  • INGREDIENTS AND APPEARANCE
    4 KIDS COLD AND COUGH DAYTIME 
    onion, calcium sulfide, sodium chloride, phosphorus, pulsatilla vulgaris, sulfur, and goldenseal liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3400
    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) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE6 [hp_X]  in 1 mL
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR12 [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
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL6 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-3400-11 in 1 CARTON08/01/2008
    1148 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
    Labeler - Hyland's (028570695)
    Establishment
    NameAddressID/FEIBusiness Operations
    Standard Homeopathic Company008316655manufacture(54973-3400) , pack(54973-3400) , label(54973-3400)
    Establishment
    NameAddressID/FEIBusiness Operations
    LGM Pharma Solutions, LLC117549198manufacture(54973-3400) , pack(54973-3400) , label(54973-3400)
    Establishment
    NameAddressID/FEIBusiness Operations
    Applied Laboratories, Inc.876754375manufacture(54973-3400) , pack(54973-3400) , label(54973-3400)

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