Label: PRESGEN- guaifenesin, phenylephrine hydrochloride, dextromethorphan hydrobromide 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 September 13, 2019

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

  • ACTIVE INGREDIENT

    Active Ingredients per 5 ml: Guaifenesin 200 mg, Phenylephrine HCL 5 mg, Dextromethorphan HBr 10 mg

  • PURPOSE

    COUGH SUPPRESSANT

    NASAL DECONGESTANT

    EXPECTORANT

  • INDICATIONS & USAGE

    Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

    temporarily relieves these symptoms occurring with cold:

    nasal congestion

    cough due to minor throat and bronchial irritation

  • WARNINGS

    Do Not Use: in a child under 2 years of age

    if you are 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 heart disease, thyroid disease, high blood pressure, diabetes

    trouble urinating due to enlargement of the prostate gland

    cough that occurs with too much phlegm (mucus)

    chronic bronchitis or emphysema

    When using this product, do not exceed recommended dosage

    Stop use and ask a doctor if

    you get 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

  • DOSAGE & ADMINISTRATION

    adults and children 12 years and over 10mL (2 tsp) every 4 hours

    children 6 to under 12 years 5mL (1 tsp) every 4 hours

    children 2 to under 6 years 2.5mL (1/2 tsp) every 4 hours

    under 2 years do not use

    do not take more than 6 doses in any 4 hour period

  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    citric acid,red 40,glycerin,methylparaben,potassium sorbate,propylene glycol,propylparaben,purified water,sodium citrate,sucralose

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    PRESGEN 
    guaifenesin, phenylephrine hydrochloride, dextromethorphan hydrobromide syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52083-632
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 5 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Product Characteristics
    Colorred (CHERRY RED) Score    
    ShapeSize
    FlavorCHERRY (SOUR CHERRY) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52083-632-16480 mL in 1 BOTTLE; Type 0: Not a Combination Product03/28/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/28/2011
    Labeler - Kramer Novis (090158395)
    Registrant - Kramer Novis (090158395)