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GILTUSS TOTAL RELEASE (Gil Pharmaceutical Corp)

Available Formats

Dosage Form Package Information Links
TABLET 100 TABLET in 1 BOTTLE (58552-317-01) Label Information
TABLET 12 BLISTER PACK in 1 CARTON (58552-317-02) > 2 TABLET in 1 BLISTER PACK Label Information

Complete GILTUSS TOTAL RELEASE Information

  • Drug Facts

    Active Ingredients (in each tablet)

    Guaifenesin 388 mg

    Dextromethorphan HBr 28 mg

    Phenylephrine HCl 10 mg


  • PURPOSE

    Purposes

    Expectorant

    Antitussive

    Nasal Decongestant


  • Uses

    • temporarily relieves these symptoms associated with a cough, the common cold, hay fever, or other upper respiratory allergies
    • helps loosen phlegm (mucus)
    • loosens nasal congestion
    • thin bronchial secretions
    • drain bronchial tubes
    • make coughs more productive
    • clears stuffy nose
    • clear nasal passageways
    • shrinks swollen membranes

  • WARNINGS

    Do not use this product more than the recommended dosage, or 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 are uncertain whether your prescription drug contains an MAOI, ask a health professional.

    Ask a doctor before use if you have

    • heart disease
    • excessive phlegm (mucus)
    • high blood pressure
    • diabetes
    • thyroid disease
    • difficulty in urination due to enlargement of the prostate gland
    • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occurs
    • symptoms are accompanied by fever, rash, persistent headache, or excessive phlegm (mucus)
    • cough and congestion do not improve within 7 days or tend to recur

    These could be signs of a serious condition.

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

    Keep out of the reach of children.

    In case of accidental overdose, get medical help or contact a Poison Control Center immediately.


  • Directions

    Do not exceed recommended doses in a 24 hour period

    Adults and Children 12 years and over: 1 tablet every 6 to 8 hours. Do not exceed 4 tablets in 24 hours.

    Children 6 to 12 years: 1/2 tablet every 6 to 8 hours. Do not exceed 2 tablets in 24 hours.

    Children under 6 years of age: ask a doctor


  • Other Information

    • store at room temperature, USP
    • do not use if imprinted safety seal under cap is broken or missing.

  • INACTIVE INGREDIENT

    Croscarmellose Sodium, Dicalcium Phosphate, Hypromellose, Magnesium Silicate, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Mineral Oil, Polyvinylpyrrolidone, Silica, Sodium Lauryl Sulfate, Stearic Acid, Titanium Dioxide and Triacetin.


  • Questions?

    Call 787-848-9114



  • SPL UNCLASSIFIED SECTION

    Manufactured for:

    GIL PHARMACEUTICAL CORP.

    Ponce, Puerto Rico 00717-1565



  • PRINCIPAL DISPLAY PANEL

    NDC 58552-317-01

    GILTUSS ®

    TOTAL RELEASE

    EXPECTORANT, ANTITUSSIVE, AND NASAL DECONGESTANT

    SUGAR FREE AND PRESERVATIVE FREE

    Each scored tablet contains:

    Guaifenesin................................388 mg.

    Dextromethorphan HBr................28 mg.

    Phenylephrine HCl........................10 mg.

    100 Tablets

    MANUFACTURED FOR:

    GIL PHARMACEUTICAL CORP.

    PONCE, PUERTO RICO 00716

    4060-gil-label


  • INGREDIENTS AND APPEARANCE
    GILTUSS TOTAL RELEASE 
    guaifenesin, dextromethorphan hbr, and phenylephrine hcl tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:58552-317
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 388 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 28 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg
    Inactive Ingredients
    Ingredient Name Strength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    TALC (UNII: 7SEV7J4R1U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    Color white Score 2 pieces
    Shape OVAL Size 15mm
    Flavor Imprint Code GIL;303
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:58552-317-02 12 in 1 CARTON 07/15/2011
    1 2 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2 NDC:58552-317-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/27/2011
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 10/19/2009
    Labeler - Gil Pharmaceutical Corp (176826592)