Label: GILTUSS TOTAL RELEASE- guaifenesin, dextromethorphan hbr, and phenylephrine hcl tablet, film coated
EXACTUSS TOTAL RELEASE- guaifenesin, dextromethorphan hbr, and phenylephrine hcl tablet, film 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 August 18, 2021

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  • 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


  • Giltuss TR

    NDC 58552-317-02

    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

    4060-24BB-1

    4060-24BB-2

  • Exactuss TR

    NDC: 58552-327-01

    Exactuss

    Total Release

    Expectorant, Antitissive, and Nasal Decongestant

    Sugar Free and Preservative free

    Exactuss TR is the bioequivalent and contains the exact ingredients of Giltuss TR

    100 Tablets

    Manufactured For

    Gil Pharmaceutical Corp.

    Ponce, Puerto Rico 00716

    4060-100G Label

  • INGREDIENTS AND APPEARANCE
    GILTUSS TOTAL RELEASE 
    guaifenesin, dextromethorphan hbr, and phenylephrine hcl tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58552-317
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN388 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE28 mg
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorwhiteScore2 pieces
    ShapeOVALSize15mm
    FlavorImprint Code GIL;GIL;303;303
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58552-317-0212 in 1 CARTON07/15/2011
    12 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:58552-317-01100 in 1 BOTTLE; Type 0: Not a Combination Product05/27/201111/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/19/2009
    EXACTUSS TOTAL RELEASE 
    guaifenesin, dextromethorphan hbr, and phenylephrine hcl tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58552-327
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN388 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE28 mg
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorwhiteScore2 pieces
    ShapeOVALSize15mm
    FlavorImprint Code GIL;GIL;303;303
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58552-327-01100 in 1 BOTTLE; Type 0: Not a Combination Product05/27/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/19/2009
    Labeler - Gil Pharmaceutical Corp (176826592)
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