Label: G-SUPRESS DX- 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 December 14, 2018

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients (in each 1mL)

    Dextromethorphan HBr, 5mg

    Guaifenesin, 50mg

    Phenylephrine HCl, 2.5mg

  • Purpose

    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

    Do not use in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

    Ask a doctor before use if the child has
    • heart disease • thyroid disease • high blood pressure
    • diabetes
    • cough that occurs with too much phlegm (mucus)
    • cough that lasts or is chronic such as occurs with asthma

    When using this product do not exceed recommended dosage.

    Stop use and ask a doctor if
    • your child gets nervous, dizzy, or sleepless
    • symptoms do not get better within 7 days or are accompanied by fever
    • cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

    Keep out of the 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. For your protection, this bottle has an imprinted seal around the neck.
    • Store at controlled room temperature 15-30°C (59-86°F).
    • Avoid excessive heat and humidity.
  • Inactive Ingredients

    citric Acid, FD&C red 40, flavor, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate and sodium saccharin.

  • SPL UNCLASSIFIED SECTION

    Compare to Suppress-DX®

    By the makers of Suppress-DX®

    COUGH SUPPRESSANT

    EXPECTORANT

    NASAL DECONGESTANT

    Cherry Flavor

    Sugar & Alcohol FREE

    Manufactured in the USA for Kramer-Novis, San Juan, PR 00917 - Tel: (787) 767-2072

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    G-SUPRESS DX  
    dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52083-655
    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)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    Colorred (CHERRY RED) Score    
    ShapeSize
    FlavorCHERRY (SOUR CHERRY) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52083-655-0130 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)