Label: PHENAGIL- chlorpheniramine maleate,phenylephrine hcl tablet

  • 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 June 13, 2022

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  • Drug Facts

    Active Ingredients (in each tablet)

    Chlorpheniramine Maleate 3.5 mg

    Phenylephrine HCl 10 mg

  • Purposes

    Antihistamine

    Nasal Decongestant

  • 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 you 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.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

  • KEEP OUT OF REACH OF CHILDREN

  • Directions

    • Adults and children 12 years and over.
      Take 1 tablet every 4 hours.
      Do not take more than 6 tablets in a 24 hours.
    • Children 6 to 12 years of age:: Take 1/2 tablet every 4 hours, Do not to exceed 3 tablets in a 24 hour period.
    • Do not use this product children under 6 years of age.
  • Other information

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

  • Inactive Ingredients

    Hydroxypropyl Methylcellulose, Lactose Monohydrate, Magnesium Stearate,
    Microcrystalline Cellulose and Polyethylene Glycol.

  • Questions? Call 787-848-9114

    Manufactured for:
    GIL PHARMACEUTICAL CORP.,
    Ponce, Puerto Rico 00716

    Manufactured by:
    Syntho Pharmaceuticals, Inc.
    Farmingdale, New York (NY) 11735
    Label revised: 04/22

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    PHENAGIL- NDC- 66576-322-01- 100's Bottle Label.

    image description

  • INGREDIENTS AND APPEARANCE
    PHENAGIL 
    chlorpheniramine maleate,phenylephrine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66576-322
    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
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code 322;Gil
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66576-322-01100 in 1 BOTTLE; Type 0: Not a Combination Product06/15/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/15/2022
    Labeler - Syntho Pharmaceuticals, Inc. (088797407)
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