Label: TUSICOF- guaifenesin, phenylephrine hcl, dextromethorphan tablet, coated

  • 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 15, 2018

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  • 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)
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