Label: TUSICOF- dextromethorphan, guaifenesin, and phenylephrine syrup

  • NDC Code(s): 52083-239-01, 52083-239-04, 52083-239-16
  • 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 November 13, 2019

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  • SPL UNCLASSIFIED SECTION

    COUGH SUPPRESSANT - EXPECTORANT
    NASAL DECONGESTANT

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each 5mL tsp)Purpose
    Dextromethorphan Hydrobromide, 20 mgCough suppressant
    Guaifenesin, 400 mgExpectorant
    Phenylephrine HCl, 10 mgNasal Decongestant
  • Uses

    • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
    • temporarily relieves these symptoms occuring with a cold:
      • nasal congestion
      • cough due to minor throat and bronchial irritation
  • 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

    • diabetes
    • heart disease
    • thyroid disease
    • high blood pressure
    • 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 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 illness.

    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 older: 5 mL (1 tsp)
    • Children under 12 years of age: consult physician
  • 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 or humidity
  • Inactive ingredients

    Artificial and natural flavors, citric acid, glycerin, menthol, methylparaben, polyethylene glycol, propylparaben, purified water, sodium citrate and sucralose

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - TUSICOF

    Principal Display Panel

    NDC 52083-239-16

    TUSICOF

    COUGH SUPPRESSANT - EXPECTORANT
    NASAL DECONGESTANT

    SUGAR & ALCOHOL FREE

    NO SACCHARIN - NO SORBITOL - NO ASPARTAME - NO DYE - NO PPA

    16 Fl. oz. (474 mL)
    Kramer Novis

    Pharmaceuticals within reach of patients

  • INGREDIENTS AND APPEARANCE
    TUSICOF 
    dextromethorphan, guaifenesin, and phenylephrine syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52083-239
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 5 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 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)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINT (Mint Flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52083-239-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product08/17/2010
    2NDC:52083-239-04120 mL in 1 BOTTLE; Type 0: Not a Combination Product08/17/2010
    3NDC:52083-239-16474 mL in 1 BOTTLE; Type 0: Not a Combination Product10/08/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/17/2010
    Labeler - Kramer Novis (090158395)
    Registrant - Kramer Novis (090158395)
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