TUSICOF (GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN) TABLET, COATED [KRAMER NOVIS.]

  • Home
  • TUSICOF (GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN) TABLET, COATED [KRAMER NOVIS.]

TUSICOF (GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN) TABLET, COATED [KRAMER NOVIS.]
PDF | XML
NDC 52083-289-02, 52083-289-60
Set ID e6391d61-36ea-4926-878c-6758f65caa7e
Category HUMAN OTC DRUG LABEL
Packager Kramer Novis.
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
View All Sections
  • Drug Facts

  • Active Ingredients (in each caplet)

    Dextromethorphan HBr, 20 mg

    Guaifenesin, 400 mg

    Phenylephrine HCl, 10 mg

  • Purpose

    Cough suppressant

    Expectorant

    Nasal Decongestant

  • Uses

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

    Do not use 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
    • 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 exceed recommended dose.

    Stop use and ask a doctor if
    • symptoms do not improve • new symptoms occur
    • redness or swelling is present
    • nervousness, dizziness or sleeplessness occur
    • symptoms do not improve within 7 days or are accompanied by fever
    • cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash or a persistent headache. A persistent cough may be a sign 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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms

  • Directions

    Adults and children 12 years of age or older: Take 1 caplet every 4 hours as needed, do not exceed 6 caplets in 24 hours, or as directed by a doctor.

    Children under 12 years: consult a doctor.

  • Other Information

    • Tamper evident feature: Do not use if packet is torn, cut or open.
    • Store at controlled room temperature 15-30°C (59-86°F).
    • Avoid excessive heat and humidity.
  • Inactive Ingredients

    Hypromellose, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, sodium starch glycolate, stearic acid

  • SPL UNCLASSIFIED SECTION

    Dextromethorphan HBr

    COUGH SUPPRESSANT

    Guaifenesin

    EXPECTORANT

    Phenylphrine HCL

    NASAL DECONGESTANT

    SUGAR & DYE FREE

    Manufactured in the USA for Kramer Novis

    San Juan, PR 00917. Tel: (787) 767-2072

    www.kramernovis.com

  • Packaging

    Tusicofnw

  • INGREDIENTS AND APPEARANCE
    TUSICOF 
    guaifenesin, phenylephrine hcl, dextromethorphan tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52083-289
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Colorwhite (snow white) Score2 pieces
    ShapeCAPSULE (T) Size19mm
    FlavorImprint Code T
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52083-289-022 in 1 PACKET; Type 0: Not a Combination Product07/18/2012
    2NDC:52083-289-6060 in 1 BOTTLE; Type 0: Not a Combination Product07/18/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/18/2012
    Labeler - Kramer Novis. (090158395)
View All Sections

Related Drugs

Search DailyMed Drugs