Label: SUPRESS DX PEDIATRIC DROPS- dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride syrup

  • 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 May 12, 2022

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  • Drug Facts

  • Active Ingredients (in each 1 mL)

    Dextromethorphan HBr, 5mg
    Guaifenesin, 50mg
    Phenylephrine HCl, 2.5mg

  • Purposes

    Cough Suppressant
    Expectorant
    Nasal Decongestant

  • Uses

    • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive   • temporarily relieves: • nasal congestion due to hay fever or other upper respiratory allergies (allergic rhinitis) • cough due to minor throat and bronchial irritation as may occur with the common cold

  • Warnings

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

  • Directions

    • do not use more than 6 doses in any 24-hour period • repeat every 4 hours • measure with the dosage device provided. Do not use with any other device • children 2 to under 6 years of age: 1 mL • children under 2 years of age: Consult a doctor.

  • Other Information

    • Tamper Evident Feature: Do not use if cap seal is torn, broken or missing. • Store at controlled room temperature 15-30°C (59-86°F)

  • Inactive Ingredients

    • Citric acid, FD&C Red 40, Flavor, Glycerin, Methylparaben, Propylene Glycol, Propylparaben, Purified Water and Sucralose.

  • Questions or comments?

    call weekdays from 8 am to 4 pm AST at 1.787.767.2072

  • SPL UNCLASSIFIED SECTION

    Sugar & Alcohol Free

    Kramer Novis Pharmaceuticals within reach of patients

    Manufactured in the USA for Kramer Novis, San Juan, PR 00917.   www.kramernovis.com

    RETAIN CARTON FOR FULL PRESCRIBING INFORMATION

  • Packaging

    SupresDX

  • INGREDIENTS AND APPEARANCE
    SUPRESS DX PEDIATRIC DROPS 
    dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52083-055
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN50 mg  in 1 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 1 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Colorred (CHERRY RED) Score    
    ShapeSize
    FlavorCHERRY (SOUR CHERRY) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52083-055-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product03/29/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/29/2011
    Labeler - KRAMER NOVIS (090158395)
    Registrant - KRAMER NOVIS (090158395)
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