Label: 4KIDS COLD N COUGH NIGHTTIME GRAPE FLAVOR- onion, matricaria recutita, arabica coffee bean, calcium sulfide, goldenseal, sodium chloride, strychnos nux-vomica seed, phosphorus, anemone pulsatilla, and sulfur liquid

  • NDC Code(s): 54973-3245-1, 54973-3245-2
  • 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 December 6, 2017

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

  • Drug Facts

    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

    Nux Vomica 6X HPUS

    (0.0000016% Alkaloids, calculated)

    frequent waking

    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

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

    Uses

    Temporarily relieves the symptoms of the common cold including cough, runny nose, sneezing, nasal and chest congestion, and sore throat with accompanying occasional sleeplessness.

    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 a 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 health care 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 band is broken or missing.

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  • Drug Facts (continued)

    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.

    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 at bedtime and every 4 hours during the night or as necessary
    Children 6 years to under 12 years 10 mL or 2 teaspoons at bedtime and every 4 hours during the night or as necessary
    Adults and children 12 years and over 15 mL or 3 teaspoons at bedtime and every 4 hours during the night or as necessary

    Inactive ingredients

    Citric Acid, Glycerine, Glycyrrhiza Extract, Natural Grape Flavor, Purified Water, Sodium Benzoate.

    Questions or comments?

    (800) 624-9659

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  • PURPOSE

    Temporarily relieves the symptoms of the common cold including cough, runny nose, sneezing, nasal and chest congestion, and sore throat with accompanying occasional sleeplessness.

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  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

    NDC 54973-3245-1
    HOMEOPATHIC

    Ages 2-12

    SINCE 1903
    Hyland's®

    4Kids

    Cold 'n
    Cough*

    NIGHTTIME

    Natural Grape Flavor

    Chest Congestion

    Occasional Sleeplessness

    Runny Nose

    Sore Throat

    Sneezing

    Cough

    Natural Grape Flavor

    ALCOHOL FREE
    SUGAR FREE
    DYE FREE

    SAFE &
    EFFECTIVE

    4 FL. OZ. (118 mL)

    Carton

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  • INGREDIENTS AND APPEARANCE
    4KIDS COLD N COUGH NIGHTTIME GRAPE FLAVOR 
    onion, matricaria recutita, arabica coffee bean, calcium sulfide, goldenseal, sodium chloride, strychnos nux-vomica seed, phosphorus, anemone pulsatilla, and sulfur liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3245
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION 6 [hp_X]  in 1 mL
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA 6 [hp_X]  in 1 mL
    ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN 6 [hp_X]  in 1 mL
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE 12 [hp_X]  in 1 mL
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL 6 [hp_X]  in 1 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE 6 [hp_X]  in 1 mL
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED 6 [hp_X]  in 1 mL
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 12 [hp_X]  in 1 mL
    ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA 6 [hp_X]  in 1 mL
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 12 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LICORICE (UNII: 61ZBX54883)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor GRAPE (Natural Grape Flavor) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54973-3245-1 1 in 1 CARTON 04/18/2016
    1 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2 NDC:54973-3245-2 5 mL in 1 PACKET; Type 0: Not a Combination Product 04/18/2016
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 04/18/2016
    Labeler - Hyland's (028570695)
    Establishment
    Name Address ID/FEI Business Operations
    Standard Homeopathic Company 008316655 manufacture(54973-3245) , pack(54973-3245)
    Establishment
    Name Address ID/FEI Business Operations
    Applied Laboratories, Inc. 117337220 manufacture(54973-3245) , pack(54973-3245)
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