ALLERGY PLUS CONGESTION (DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES, LLC]

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  • ALLERGY PLUS CONGESTION (DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES, LLC]

ALLERGY PLUS CONGESTION (DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES, LLC]
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NDC 36800-985-08
Set ID a1767b69-bf64-4ae7-ab99-d687c9b71e2a
Category HUMAN OTC DRUG LABEL
Packager Topco Associates, LLC
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
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  • Active ingredients (in each tablet)

    Diphenhydramine HCl 25 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:
      • nasal congestion
      • runny nose
      • sneezing
      • itchy nose or throat
      • itchy, watery eyes
      • sinus congestion and pressure
    • temporarily relieves these symptoms due to the common cold:
      • nasal congestion
      • runny nose
      • sneezing
      • 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.
    • with any other product containing diphenhydramine, even one used on skin

    Ask a doctor before use if you have

    • heart disease
    • diabetes
    • high blood pressure
    • trouble urinating due to an enlarged prostate gland
    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma
    • thyroid disease

    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
    • marked 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

    • symptoms do not improve within 7 days or are accompanied by fever
    • nervousness, dizziness, or sleeplessness occur

    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 (1-800-222-1222) right away.

  • Directions

    • adults and children 12 years of age 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 this product in children under 12 years of age
  • Other information

    • 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, dicalcium phosphate, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, silica gel, stearic acid, titanium dioxide, triacetin

  • Questions or comments?

    1-888-423-0139

  • Principal Display Panel

    TopCare®

    NDC 36800-985-08

    REGULAR STRENGTH

    Allergy Plus
    Sinus

    DIPHENHYDRAMINE HCl
    PHENYLEPHRINE HCl

    ANTIHISTAMINE • NASAL DECONGESTANT

    Relief of:

    • Sneezing   • Itchy, Watery Eyes
    • Runny Nose  • Itchy Throat
    • Sinus Congestion   •Sinus Pressure
    Easy to Swallow

    QUALITY GUARANTEED 

    COMPARE TO BENADRYL-D® ALLERGY PLUS SINUS active ingredients*

    actual size

    24 TABLETS

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

    *This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Benadryl-D® Allergy Plus Sinus.

    50844   ORG051248508

    TopCare 44-485

    TopCare 44-485

  • INGREDIENTS AND APPEARANCE
    ALLERGY PLUS CONGESTION 
    diphenhydramine hcl, phenylephrine hcl tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-985
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    ColorBLUEScoreno score
    ShapeOVALSize11mm
    FlavorImprint Code 44;485
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-985-082 in 1 CARTON08/10/200503/19/2022
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34108/10/200503/19/2022
    Labeler - Topco Associates, LLC (006935977)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894MANUFACTURE(36800-985)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837PACK(36800-985)
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