Label: KIDS COUGH AND MUCUS NIGHTTIME GRAPE FLAVOR- rumex crispus root, antimony potassium tartrate, bryonia alba root, matricaria chamomilla whole, pulsatilla vulgaris, calcium sulfide, ipecac, goldenseal, phosphorus, ferrosoferric phosphate liquid

  • NDC Code(s): 54973-4057-1
  • Packager: Hyland's Consumer Health 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 April 25, 2024

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  • PURPOSE

    Temporarily relieves symptoms of common cold in children at night, including cough, runny nose, sneezing, sore throat, chest or nasal congestion, mucus in chest or throat, occasional sleeplessness

  • Drug Facts

    Active ingredients

    Active ingredientsPurpose
    Antimonium Tartaricum 15X HPUScough
    Bryonia Alba 15X HPUSsore throat, mucus in throat, cough
    Chamomilla 6X HPUSoccasional sleeplessness
    Ferrum Phosphoricum 12X HPUSmucus in throat, cough
    Hepar Sulph Calc 12X HPUSmucus in chest, cough
    Hydrastis Canadensis 15X HPUSoccasional sleeplessness
    due to mucus in throat
    Ipecacuanha 12X HPUScough, sore throat
    Phosphorus 15X HPUSrunny nose, chest or nasal congestion
    Pulsatilla 12X HPUSmucus in chest or throat, cough, sneezing
    Rumex Crispus 6X HPUSrunny nose, sneezing

    "HPUS" is the Homeopathic Pharmacopoeia of the United States.

  • Uses

    Temporarily relieves symptoms of common cold in children at night, including: ■ cough ■ runny nose ■ sneezing ■ sore throat
    ■ chest or nasal congestion ■ mucus in chest or 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?

    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.

  • Principal Display Panel

    Hyland's

    NATURALS™

    •Kids•

    Cough &

    Mucus*

    NIGHTTIME

    NO ALCOHOL, SUGAR,

    PARABENS or DYES

    Sleeplessness

    Cough

    Mucus

    Congestion

    Runny Nose

    EFFECTIVE

    MUCUS

    RELIEF

    2-12

    YEARS

    NATURAL

    GRAPE FLAVOR

    4 FL. OZ. (118 mL)

    HOMEOPATHIC

    Carton

  • INGREDIENTS AND APPEARANCE
    KIDS COUGH AND MUCUS NIGHTTIME GRAPE FLAVOR 
    rumex crispus root, antimony potassium tartrate, bryonia alba root, matricaria chamomilla whole, pulsatilla vulgaris, calcium sulfide, ipecac, goldenseal, phosphorus, ferrosoferric phosphate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-4057
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    RUMEX CRISPUS ROOT (UNII: 9N1RM2S62C) (RUMEX CRISPUS ROOT - UNII:9N1RM2S62C) RUMEX CRISPUS ROOT6 [hp_X]  in 1 mL
    IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L) IPECAC12 [hp_X]  in 1 mL
    ANTIMONY POTASSIUM TARTRATE (UNII: DL6OZ476V3) (ANTIMONY CATION (3+) - UNII:069647RPT5) ANTIMONY POTASSIUM TARTRATE15 [hp_X]  in 1 mL
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT15 [hp_X]  in 1 mL
    MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA WHOLE - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA WHOLE6 [hp_X]  in 1 mL
    FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7) FERROSOFERRIC PHOSPHATE12 [hp_X]  in 1 mL
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE12 [hp_X]  in 1 mL
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS12 [hp_X]  in 1 mL
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL15 [hp_X]  in 1 mL
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS15 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPE (Natural Grape Flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-4057-11 in 1 CARTON03/01/2022
    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 homeopathic03/01/2022
    Labeler - Hyland's Consumer Health Inc. (008316655)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hyland's Consumer Health Inc.008316655manufacture(54973-4057) , pack(54973-4057) , label(54973-4057)
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