Label: TUSSI PRES- guaifenesin, phenylephrine hydrochloride, dextromethorphan hydrobromide syrup

  • NDC Code(s): 52083-231-04, 52083-231-10, 52083-231-16
  • Packager: Kramer Novis
  • 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 5mL tsp)

    Dextromethorphan HBr 10 mg

    Guaifenesin 200 mg

    Phenylephrine HCl 5 mg

  • Purposes

    Cough suppressant

    Expectorant

    Nasal decongestant

  • Uses

    • 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          • 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
    • 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.

    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 10 mL (2 tsp)
    CHILDREN 6 YEARS TO UNDER 12 YEARS 5 mL (1 tsp)
    CHILDREN 2 YEARS TO UNDER 6 YEARS 2.5 mL (1/2 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, FD&C Red 40, flavor, glycerin, methylparaben, potassium sorbate, propylene glycol, propylparaben, purified water, sodium citrate, and sucralose.

  • SPL UNCLASSIFIED SECTION

    Dextromethorphan HBr

    COUGH SUPPRESSANT

    Guaifenesin

    EXPECTORANT

    Phenylephrine HCl

    NASAL DECONGESTANT

    SUGAR, ALCOHOL, SACCHARIN & SORBITOL FREE

    CHERRY FLAVOR

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

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

  • Packaging

    Tusi10

    Tusi16

  • INGREDIENTS AND APPEARANCE
    TUSSI PRES 
    guaifenesin, phenylephrine hydrochloride, dextromethorphan hydrobromide syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52083-231
    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
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    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:52083-231-16480 mL in 1 BOTTLE; Type 0: Not a Combination Product03/28/2011
    2NDC:52083-231-04120 mL in 1 BOTTLE; Type 0: Not a Combination Product03/28/201107/12/2017
    3NDC:52083-231-1010 mL in 1 PACKET; 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)