Label: TUSICOF - guaifenesin, dextromethorphan hydrobromide and phenylephrine hydrochloride tablet, coated

  • NDC Code(s): 52083-289-02, 52083-289-60
  • Packager: Kramer Novis.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 08/12

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredients (In Each Tablet)
    Guaifenesein 400 mg
    Phenylephrine HCl 10 mg
    Dextromethorphan HBr. 20 mg

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  • PURPOSE

    Expectorant, nasal decongestant, antitussive (anti cough)

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  • INDICATIONS & USAGE

    Uses: temporarily relieves these symptoms occurring with a cold

    nasal decongestion: cough due to minor throat and bronchial irritation

    • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

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  • DOSAGE & ADMINISTRATION

    Directions:
    Adults and children 12 years of age and older
    • Take 1 tablet every 4 hours as needed, do not exceed 6
    tablets in 24 hours, or as directed by a doctor.
    • Children under 12 years, consult a doctor
    • Warnings:

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  • WARNINGS

    Warnings:
    • when using this product do not exceed recommended dose.
    • 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 MAOI drug. If you do not know if your prescription
    drug contains an MAOI, consult a doctor or pharmacist before
    taking this product
    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 a fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition
    Ask a doctor before use if you have:
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • difficulty in urination due to enlargement of the prostate gland
    • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema or where cough is accompanied by excessive phlegm (mucus)

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  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding baby, ask a health professional
    before use.

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  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN. In case of 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.

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  • INACTIVE INGREDIENT

    Inactive Ingredients: Hypromellose, Microcrystalline Cellulose, Polydextrose, Polyethylene Glycol, Povidone, Sodium Starch Glycolate, Stearic Acid

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  • PRINCIPAL DISPLAY PANEL

    MM1
    Tusicof Caplet




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  • INGREDIENTS AND APPEARANCE
    TUSICOF 
    guaifenesin, phenylephrine hcl, dextromethorphan tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:52083-289
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 400 mg
    DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 20 mg
    PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 10 mg
    Inactive Ingredients
    Ingredient Name Strength
    CELLULOSE, MICROCRYSTALLINE  
    POLYDEXTROSE  
    PROPYLENE GLYCOL  
    POVIDONE K30  
    SODIUM STARCH GLYCOLATE TYPE A POTATO  
    STEARIC ACID  
    Product Characteristics
    Color white (snow white) Score 2 pieces
    Shape CAPSULE (T) Size 19mm
    Flavor Imprint Code T
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52083-289-02 2 in 1 PACKET
    2 NDC:52083-289-60 60 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 07/18/2012
    Labeler - Kramer Novis. (090158395)
    Registrant - Ultraseal Corporation (085752004)
    Establishment
    Name Address ID/FEI Business Operations
    Ultratab Laboratories, Inc. 151051757 manufacture(52083-289)
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