Label: PHENAGIL- chlorpheniramine maleate, dextromethorphan hbr and 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

If you are a consumer or patient please visit this version.

  • Drug Facts

    Active ingredients
    (in each tablet)

    Chlorpheniramine maleate 3.5 mg
    Dextromethorphan HBr 29 mg
    Phenylephrine HCI 10 mg

  • Purposes

    Antihistamine
    Cough suppressant
    Nasal decongestant

  • Uses

    Temporarily relieves:

    • cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants.

    • nasal congestion due to the common cold, hay fever or other upper respiratory allergies.

    • temporarily relieves these symptoms due to hay fever (allergic rhinitis):

      • runny nose.

      • sneezing.

      • itchy, watery eyes.

      • itching of the nose or throat.

      • temporarily restores freer breathing through the nose.

  • Warnings

    Do not use

    • to sedate a child or to make a child sleepy.
    • 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.
    • glaucoma.
    • cough that occurs with too much phlegm (mucus).
    • a breathing problem or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema.

  • Ask a doctor or pharmacist before use if you are

    • taking sedatives or tranquilizers.
    • taking any other oral nasal decongestant or stimulant.

  • When using this product

    • do not use more than directed.
    • may cause drowsiness.
    • avoid alcoholic beverages.
    • alcohol, sedatives, and tranquilizers may increase drowsiness.
    • be careful when driving a motor vehicle or operating machinery.
    • excitability may occur, especially in children.

  • Stop use and ask a doctor if

    • you get nervous, dizzy, or sleepless.
    • symptoms do not get better within 7 days or are accompanied by fever.
    • cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

  • PREGNANCY OR BREAST FEEDING

  • KEEP OUT OF REACH OF CHILDREN

    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.

  • Directions

    Adults and Children 12 years and over.: Take one tablet every 6-8 hours.
       Do not take more than 4 tablets in a 24 hour period.
    Children 6 to 12 years of age: Take 1/2 tablet every 6-8 hours.
       Do not take more than 2 tablets in a 24 hour period.
    Children under 6 years: Consult a doctor.

  • Other information

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

  • Inactive ingredients

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

  • Questions or comments?

    Call 1-787-848-9114, Monday–Friday 9AM-5PM EST. Call your doctor for medical advice in the event of side effects.


    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 ® CH - NDC 66576-337-01 - 100's Bottle Label.

    image description

  • INGREDIENTS AND APPEARANCE
    PHENAGIL 
    chlorpheniramine maleate, dextromethorphan hbr and phenylephrine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66576-337
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE3.5 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)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize3mm
    FlavorImprint Code 323;Gil
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66576-337-01100 in 1 BOTTLE; Type 0: Not a Combination Product05/26/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/26/2022
    Labeler - Syntho Pharmaceuticals, Inc. (088797407)