Label: GILTUSS TR- guaifenesin,dextromethorphan hbr,phenylephrine hcl tablet

  • NDC Code(s): 58552-335-01, 58552-335-02
  • Packager: Gil Pharmaceutical Corp
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 24, 2023

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  • Drug Facts

    Active Ingredients(in each tablet)

    Guaifenesin 390 mg.

    Dextromethorphan HBr 29 mg.

    Phenylephrine HCl 10 mg.

  • Purposes

    Expectorant

    Antitussive

    Nasal Decongestant

  • 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, clear stuffy nose, clear nasal passageways, and shrinks swollen membranes.

  • Warnings

    Do not usethis 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.

  • PREGNANCY OR BREAST FEEDING

    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.

  • KEEP OUT OF REACH OF CHILDREN

  • 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 Ingredients

    Hydroxypropyl Methylcellulose, Magnesium Stearate, Maltodextrin, Microcrystalline  Cellulose, Polyethylene Glycol, Povidone, Silicone Dioxide and Stearic Acid.

  • Questions? Call 787-848-9114

    Manufactured for:

    GIL PHARMACEUTICAL CORP.

    Ponce, Puerto Rico 00716

    Label revised: 04/22

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Giltuss ®Total Release - NDC-58552-335-01 - 100's Bottle Label.

    image description

  • INGREDIENTS AND APPEARANCE
    GILTUSS TR 
    guaifenesin,dextromethorphan hbr,phenylephrine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58552-335
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN390 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE29 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize8mm
    FlavorImprint Code 303;Gil
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58552-335-01100 in 1 BOTTLE; Type 0: Not a Combination Product01/07/2022
    2NDC:58552-335-022 in 1 BLISTER PACK; Type 0: Not a Combination Product01/07/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01201/07/2022
    Labeler - Gil Pharmaceutical Corp (176826592)
    Registrant - Syntho Pharmaceuticals, Inc (113616187)
    Establishment
    NameAddressID/FEIBusiness Operations
    Syntho Pharmaceuticals, Inc.088797407manufacture(58552-335)
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