TUSICOF (DEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINE) SYRUP [KRAMER NOVIS]

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TUSICOF (DEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINE) SYRUP [KRAMER NOVIS]
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NDC 52083-239-01, 52083-239-04, 52083-239-16
Set ID e966b75c-4bb4-4216-8247-baada8f5d759
Category HUMAN OTC DRUG LABEL
Packager Kramer Novis
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
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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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