Label: PHENAGIL- phenylephrine hcl and chlorpheniramine maleate tablet

  • NDC Code(s): 58552-322-01, 58552-322-02
  • 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

  • Uses

    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

    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).

  • Directions

    Adults and Children12 years of age and over:take 1 tablet every 4-6 hours. Do not exceed 6 tablets in 24 hours
    Children 6 to under 12 years of age:1/2 tablet every 4-6 hours, not to exceed 3 tablets in a 24 our period
    Children under 6 years of age:Consult a physician.


  • Other Informaton

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

  • INACTIVE INGREDIENT

    Magnesium Stearate, Microcrystalline Cellulose and Silica.

  • QUESTIONS

    Questions? Call 787-848-9114
    Manufactured for: GIL PHARMACEUTICAL CORP. Ponce, Puerto Rico 00716

  • PRINCIPAL DISPLAY PANEL

    NDC 58552-322-01
    PHENAGIL

    ANTIHISTAMINE AND NASAL DECONGESTANT

    SUGAR FREE AND DYE FREE

    Each tablet contains:
    Chlorpheniramine Maleate 3.5 mg
    Phenylephrine HCI 10 mg

    100 Tablets

    MANUFACTURED FOR
    GIL PHARMACEUTICAL CORP.

    PONCE, PUERTO RICO 00716

    4131-label

  • INGREDIENTS AND APPEARANCE
    PHENAGIL 
    phenylephrine hcl and chlorpheniramine maleate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58552-322
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE3.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code 322;GIL
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58552-322-01100 in 1 BOTTLE; Type 0: Not a Combination Product12/14/2012
    2NDC:58552-322-0212 in 1 BOX12/14/2012
    22 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01212/14/2012
    Labeler - Gil Pharmaceutical Corp (176826592)
    Establishment
    NameAddressID/FEIBusiness Operations
    Syntho Pharmaceuticals Inc088797407manufacture(58552-322)
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