Label: PRESGEN PEDIATRIC- guaifenesin, phenylephrine hcl,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 December 13, 2018

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

  • Drug Facts

  • Active Ingredients (in each 5 ml tsp):

    Dextromethorphan HBr, 5 mg

    Guaifenesin 75 mg

    Phenylephrine HCl, 2.5 mg

  • Purpose:

    Cough suppressant

    Expectorant

    Nasal Decongestant

  • Uses:

    • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make cough 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 under 2 years of age.

    • 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 your child has

    • heart disease          • high blood pressure

    • thyroid disease       • diabetes

    • trouble urinating due to an enlarged prostate gland

    • cough that occurs with too much phlegm (mucus)

    • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema.

    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.

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

    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 take more than 6 doses in any 24-hour period

    EVERY 4 HOURS ADULTS AND CHILDREN 12 YEARS AND OVER 20 mL (4 tsp)
     CHILDREN 6 YEARS TO UNDER 12 YEARS 10 mL (2 tsp)
     CHILDREN 2 YEARS TO UNDER 6 YEARS 5 mL   (1 tsp)
     CHILDREN UNDER 2 YEARS OF AGE do not use

  • Other information

    • Tamper evident feature: Do not use if inner seal is torn, broken or missing.

    • Store at controlled room temperature 15-30°C (59-86°F).

    • Avoid excessive heat and humidity.

  • Inactive Ingredients:

     Citric Acid, Flavor, Glycerin, Methylparaben, Propylene Glycol, Propylparaben, Purified Water, Sodium Citrate and Sucralose

  • SPL UNCLASSIFIED SECTION

    Compare to Tussi-Pres Pediatric®

    Dextromethorphan HBr

    COUGH SUPPRESSANT

    Guaifenesin

    EXPECTORANT

    Phenylephrine HCl

    NASAL DECONGESTANT

    SUGAR AND ALCOHOL FREE

    SACCHARIN & SORBITOL FREE

    DYE FREE

    ORANGE FLAVOR

    Manufactured in the USA for Kramer-Novis, San Juan, PR 00917

    Tel: (787) 767-2072 www.kramernovis.com

  • Packaging

    Pres1

  • INGREDIENTS AND APPEARANCE
    PRESGEN PEDIATRIC 
    guaifenesin, phenylephrine hcl,dextromethorphan hydrobromide syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52083-653
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN75 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorORANGE (CITRUS ORANGE) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52083-653-16480 mL in 1 BOTTLE; Type 0: Not a Combination Product03/24/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/24/2011
    Labeler - KRAMER NOVIS (090158395)
    Registrant - KRAMER NOVIS (090158395)