Label: GILTUSS D ALLERGY AND CONGESTION- chlorpheniramine maleate, phenylephrine hcl tablet

  • NDC Code(s): 58552-333-20, 58552-333-25
  • 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 Ingredients (in each tablet)

    Chlorpheniramine Maleate 3.5 mg
    Phenylephrine HCl 10 mg

  • PURPOSE

    Purposes
    Antihistamine
    Nasal Decongestant

  • INDICATIONS & USAGE

    Uses
    Temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:

    • runny nose
    • sneezing
    • itchy, watery eyes
    • nasal congestion
    • itching of the nose or throat
    • sinus congestion and pressure

  • WARNINGS

    Warnings

    Do not use 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 do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

    Ask a doctor before use if you have

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • trouble urinating due to an enlarged prostate gland
    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma

    Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

    When using this product

    • do not exceed recommended dose
    • excitability may occur, especially in children
    • drowsiness may occur
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • avoid alcoholic drinks
    • be careful when driving a motor vehicle or operating machinery

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occurs
    • symptoms do not improve within 7 days or occur with a fever

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

    Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

  • DOSAGE & ADMINISTRATION

    Directions

    adults and children 12 years and over

    • take 1 tablet every 4 hours
    • do not take more than 6 tablets in 24 hours
    • children 6 to under 12 years of age: take 1/2 tablet every 4 hours, not to exceed 3 tablets in a 24 hour period
    • do not use this product for children under 6 years of age
  • STORAGE AND HANDLING

    Other information

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

  • INACTIVE INGREDIENT

    Inactive ingredients

    Magnesium Stearate, Microcrystalline Cellulose and Silica.

  • 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

    NO PSEUDOEPHEDRINE

    Giltuss®-D

    ALLERGY & CONGESTION

    20 TABLETS

    SUGAR FREE. ALCOHOL FREE. DYE FREE. SODIUM FREE

    RELIEVES

    • SNEEZING
    • RUNNY NOSE
    • ITCHY, WATERY EYES
    • ITCHY THROAT OR NOSE
    • SINUS PRESSURE
    • STUFFY NOSE

    58552-333 Giltuss D 1-16-2019

  • INGREDIENTS AND APPEARANCE
    GILTUSS D ALLERGY AND CONGESTION 
    chlorpheniramine maleate, phenylephrine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58552-333
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE3.5 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code GIL;322
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58552-333-2010 in 1 BOX11/17/2016
    12 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:58552-333-2525 in 1 CARTON05/28/201901/01/2023
    21 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01211/17/2016
    Labeler - Gil Pharmaceutical Corp (176826592)
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