Label: PEDIACARE CHILDRENS COUGH AND CONGESTION GRAPE- dextromethorphan hydrobromide and guaifenesin syrup

  • NDC Code(s): 52412-992-01
  • Packager: RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 30, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each 5 mL)Purposes
    Dextromethorphan HBr, USP 5 mgCough suppressant
    Guaifenesin, USP 100 mgExpectorant
  • Uses

    • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
    • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
  • Warnings

    Do not useif you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

    Ask a doctor before use if you have

    • cough that occurs with too much phlegm (mucus)
    • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

    Stop use and ask a doctor ifcough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistant headache. These could be signs of a serious condition.

    If pregnant or breast-feeding,ask a health professional before use.

    Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    • do not take more than 6 doses in any 24-hour period
    • measure only with dosing cup provided
    • keep dosing cup with product
    • mL=milliliter
    AGEDOSE
    children under 4 yearsdo not use
    children 4 to under 6 years5 mL every 4 hours
    children 6 to under 12 years10 mL every 4 hours
    adults and children 12 years and over20 mL every 4 hours
  • Other information

    • store at 20-25°C (68-77°F)
    • do not refrigerate
    • alcohol-free
  • Inactive ingredients

    acesulfame potassium, citric acid anhydrous, glycerin, flavor, menthol, polyethylene glycol, povidone, propylene glycol, purified water, sodium benzoate, sodium saccharin

  • SPL UNCLASSIFIED SECTION

    Distributed by
    CrossingWell Consumer Health
    PO Box 440
    Cornwall, NY 12518

  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

    Fast Acting

    Pedia
    Care ®

    100% dedicated
    to kids™

    4 Years & Up

    COUGH &
    CONGESTION

    Relieves:

    • Congestion & Mucus
    • Cough

    Dextromethorphan HBr, USP (5 mg per 5 mL)
    Guaifenesin, USP (100 mg per 5 mL)

    Non-Drowsy

    Grape Flavor

    4 FL OZ (118 mL)

    Principal Display Panel - 118 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    PEDIACARE CHILDRENS COUGH AND CONGESTION GRAPE 
    dextromethorphan hydrobromide and guaifenesin syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52412-992
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    ColorpurpleScore    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52412-992-011 in 1 CARTON01/03/2023
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01201/03/2023
    Labeler - RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH (061995007)
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