Label: PHENAGIL CH- phenyleprine hcl, chlorpheniramine maleate and chlophedianol 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 December 30, 2020

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  • Drug Facts

    Active Ingredients (in each tablet)


    Chlorpheniramine Maleate 3.5 mg
    Phenylephrine HCl 10 mg
    Chlophedianol HCl 24 mg

  • PURPOSE

    Purposes

    Antihistamine
    Nasal Decongestant
    Cough Suppressant

  • Uses

    Uses

    Temporarily relieves runny nose and alleviates sneezing, itchy, watery eyes due to hay fever or other upper respiratory allergies. Temporarily relieves nasal congestion due to the common cold. Temporarily controls cough due to minor bronchial irritation occurring with the common cold.

  • 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

    • persistent or chronic cough such as occurs with smoking, asthma

    • chronic bronchitis, or emphysema

    • excessive phlegm (mucus)

    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

    • cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache

    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).

  • Directions

    Adults and Children 12 years of age and over: take 1 tablet every 6 hours. Do not exceed 4 tablets in 24 hours
    Children 6 to under 12 years of age:

    take 1/2 tablet every 6 hours as needed.

    Do not exceed 2 tablets in 24 hours

    Children under 6 years of age: Consult a physician.

  • Other information

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

  • INACTIVE INGREDIENT

    Croscarmellose Sodium, 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 58552-323-01

    PHENAGIL® CH

    ANTIHISTAMINE, NASAL DECONGESTANT AND ANTITUSSIVE
    SUGAR FREE AND DYE FREE
    Each tablet contains:
    Chlorpheniramine Maleate 3.5 mg
    Phenylephrine HCI 10 mg
    Chlophedianol HCl 24 mg

    100 Tablets

    MANUFACTURED FOR
    GIL PHARMACEUTICAL CORP.
    PONCE, PUERTO RICO 00716

    Gil label

  • INGREDIENTS AND APPEARANCE
    PHENAGIL CH 
    phenyleprine hcl, chlorpheniramine maleate and chlophedianol hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58552-323
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOPHEDIANOL HYDROCHLORIDE (UNII: 69QQ58998Y) (CHLOPHEDIANOL - UNII:42C50P12AP) CHLOPHEDIANOL HYDROCHLORIDE24 mg
    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)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code GIL;323
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58552-323-0212 in 1 BOX06/17/2015
    12 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:58552-323-01100 in 1 BOTTLE; Type 0: Not a Combination Product06/17/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/17/2015
    Labeler - Gil Pharmaceutical Corp (176826592)
    Registrant - Contract Pharmacal Corp. (057795122)
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