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
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 20, 2022

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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 use if 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 if cough 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 finalpart34101/03/2023
    Labeler - RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH (061995007)
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