Label: TUSSLIN- dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride syrup

  • Category: HUMAN OTC DRUG LABEL

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 16, 2019

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Drug Facts

  • Active Ingredients (in each 5 mL tsp)

    Dextromethorphan HBr, 28 mg

    Guaifenesin, 388 mg

    Phenylephrine HCl, 10 mg

  • Purposes

    Antitussive

    Expectorant

    Nasal Decongestant

  • Uses

    • suppresses cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passages of bothersome mucus, drain bronchial tubes, and make cough more productive • temporarily relieves nasal congestion due to a cold
  • Warnings

    Do not use if you are now 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 the enlarged prostate gland • cough that occurs with too much phlegm (mucus) • a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema.

    Ask a doctor or pharmacist before use if you are taking any other oral nasal decongestant or stimulant.

    When using this product, do not use more than directed

    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

    • Take every 6 hours, or as directed by a doctor.

    Adults and children 12 years of age and olderTake one teaspoonful (5 mL). Do not exceed 4 teaspoonfuls in 24 hours
    Children 6 to under 12 years of ageTake 1/2 teaspoonful (2.5 mL). Do not exceed 2 teaspoonfuls in 24 hours
    Children 2 to under 6 years of ageTake 1/4 teaspoonful (1.25 mL). Do not exceed 1 teaspoonful in 24 hours
    Children under 2 years of ageConsult a doctor

  • Other information

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

    Citric acid, flavor, glycerin, methylparaben, propylparaben, polyethylene glycol, purified water, sodium citrate, and sucralose.

  • Questions or comments?

    Call weekdays from 8 AM to 4 PM AST at 1-787-767-2072. San Juan, PR 00917
    www.kramernovis.com

  • SPL UNCLASSIFIED SECTION

    NDC 52083-622-16

    Contains the same active ingredients as Giltuss®*

    Sugar, Alcohol, and Dye FREE

    GRAPE FLAVOR

    Manufactured in the USA for 

    Kramer Novis

    *Giltuss® is a registered trademark of Gil Pharmaceutical Corp. This product is not manufactured, distributed or marketed by Gil Pharmaceutical Corp.

  • Packaging

    Tusln1

  • INGREDIENTS AND APPEARANCE
    TUSSLIN 
    dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52083-622
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE28 mg  in 5 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN388 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorPURPLE (clear, purple) Score    
    ShapeSize
    FlavorGRAPE (artificial grape flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52083-622-16474 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/01/2014
    Labeler - Kramer Novis (090158395)