Label: GILTUSS SINUS AND CHEST CONGESTION- guaifenesin, phenylephrine hcl tablet

  • NDC Code(s): 58552-332-20
  • Packager: Gil Pharmaceutical Corp
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 24, 2023

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  • Drug Facts

    Active Ingredient (in each tablet)

    Guaifenesin 388 mg

    Phenylephrine HCl 10 mg

  • PURPOSE

    Purpose

    Expectorant

    Nasal Decongestant

  • INDICATIONS & USAGE

    Uses

    temporarily relieves the 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

    Warnings

    Do not use

    • more than the recommended dosage
    • this product 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 4 hours. Do not exceed 6 tablets in 24 hours.
    • Children 6 to 12 years: 1/2 tablet every 4 hours. Do not exceed 3 tablets in 24 hours
    • Children under 6 years of age: ask a doctor
  • Other information

    Other information

    • store at room temperature, USP
    • do not use if blister seal is broken
  • INACTIVE INGREDIENT

    Inactive ingredients Croscarmellose Sodium, Hypromellose, Lactose, Magnesium Silicate, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Mineral Oil, Polyethylene Glycol, Polyvinylpyrrolidone, Silica, Sodium Lauryl Sulfate, Stearic Acid, Titanium Dioxide and Triacetin.

  • QUESTIONS

    Questions? Call 787-848-9114

  • SPL UNCLASSIFIED SECTION

    MANUFACTURED FOR GIL PHARMACEUTICAL CORP.

    PONCE, PUERTO RICO 00717-1565

    giltuss.com

  • PRINCIPAL DISPLAY PANEL

    MAXIMUM STRENGTH

    GILTUSS®

    SINUS & CHEST CONGESTION

    20 TABLETS

    NON-DROWSY. DYE FREE. PRESERVATIVE . SODIUM FREE

    RELIEVES

    • STUFFY NOSE
    • NASAL CONGESTION
    • SINUS PRESSURE
    • CHEST CONGESTION
    • LOOSENS PHLEGM AND MUCUS

    58552-332 Sinus Chest Congestion 11-2-2018

  • INGREDIENTS AND APPEARANCE
    GILTUSS SINUS AND CHEST CONGESTION 
    guaifenesin, phenylephrine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58552-332
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN388 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LACTOSE (UNII: J2B2A4N98G)  
    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)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeOVALSize19mm
    FlavorImprint Code GILGIL;304304
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58552-332-202 in 1 CARTON04/01/2021
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01204/01/2021
    Labeler - Gil Pharmaceutical Corp (176826592)
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