Label: SINUS AND ALLERGY RELIEF PE- chlorpheniramine maleate, phenylephrine hcl tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated July 22, 2023

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  • Active ingredients (in each tablet)

    Chlorpheniramine maleate 4 mg
    Phenylephrine HCl 10 mg

  • Purpose

    Antihistamine
    Nasal decongestant

  • Uses

    • temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:
      • runny nose
      • sneezing
      • itching of the nose or throat
      • itchy, watery eyes
      • sinus congestion and pressure
      • nasal congestion
  • 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

    • high blood pressure
    • heart disease
    • thyroid disease
    • diabetes
    • glaucoma
    • difficulty in urination due to enlargement of the prostate gland
    • a breathing problem such as emphysema or chronic bronchitis

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers.

    When using this product

    • do not exceed recommended dosage
    • excitability may occur, especially in children
    • drowsiness may occur
    • avoid alcoholic beverages
    • alcohol, sedatives and tranquilizers may increase drowsiness
    • use caution when driving a motor vehicle or operating machinery

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur
    • 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 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 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours.
    • children under 12 years: do not use
  • Other information

    • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • see end flap for expiration date and lot number
  • Inactive ingredients

    croscarmellose sodium, lactose anhydrous, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid

  • Questions or comments?

    1-888-423-0139

  • Principal display panel

    +TopCare®
    health

    NDC 36800-642-08

    MAXIMUM STRENGTH
    Sinus & Allergy Relief PE

    CHLORPHENIRAMINE MALEATE 4 mg - ANTIHISTAMINE
    PHENYLEPHRINE HCl 10 mg - NASAL DECONGESTANT

    RELIEVES:
    • Sneezing                  • Sinus Congestion & Pressure
    • Runny Nose             • Itching of the Nose or Throat
    • Nasal Congestion    • Itchy, Watery Eyes

    24 TABLETS

    actual size

    TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT
    IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

    DISTRIBUTED BY TOPCO ASSOCIATES LLC
    ELK GROVE VILLAGE, IL 60007
    ©TOPCO LNKA0621
    QUESTIONS? 1-888-423-0139
    topcare@topco.com
    www.topcarebrand.com

    50844    ORG031946208

    QUALITY GUARANTEED
    This TopCare® product is laboratory
    tested to guarantee its highest quality.
    Your total satisfaction is guaranteed.

    TopCare 44-462

    TopCare 44-462

  • INGREDIENTS AND APPEARANCE
    SINUS AND ALLERGY RELIEF PE 
    chlorpheniramine maleate, phenylephrine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-642
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE4 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code 44;462
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-642-081 in 1 CARTON07/02/2021
    124 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01207/02/2021
    Labeler - Topco Associates, LLC (006935977)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837pack(36800-642)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(36800-642)
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