Label: ALLERGY PLUS SINUS RELIEF- diphenhydramine hcl and phenylephrine hcl tablet, film coated

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

Drug Label Information

Updated April 16, 2024

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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 or other upper respiratory allergies:
      • nasal congestion
      • runny nose
      • sneezing
      • itching of the nose or throat
      • itchy, watery eyes
    • temporarily relieves these symptoms due to the common cold:
      • nasal congestion
      • runny nose
      • sneezing
    • temporarily relieves 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
    • difficulty in urination due to enlargement of the 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 dosage
    • excitability may occur, especially in children
    • marked drowsiness may occur
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • avoid alcoholic beverages
    • use caution 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 right away.

  • Directions

    • do not take more than directed
    • 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

    • each tablet contains: calcium 25 mg
    • 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, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, silicon dioxide, stearic acid, titanium dioxide, triacetin

  • Questions or comments?

    1-800-426-9391

  • Principal display panel

    Compare to the active ingredients in
    Benadryl® Allergy Plus Congestion*

    ALLERGY PLUS
    SINUS RELIEF
    PHENYLEPHRINE HCl
    DIPHENHYDRAMINE HCl

    ANTIHISTAMINE
    NASAL DECONGESTANT
    RELIEF OF
    Sneezing, runny nose, sinus congestion,
    sinus pressure, itchy throat,
    & itchy, watery eyes

    24 
    TABLETS

    *This product is not manufactured or distributed by Johnson & Johnson
    Corporation, owner of the registered trademark Benadryl® Allergy Plus Congestion.
    50844        ORG122048508

    DISTRIBUTED BY:
    RITE AID, 200 NEWBERRY COMMONS,
    ETTERS, PA 17319 www.riteaid.com

    SATISFACTION GUARANETT: If you're not
    satisfied, we'll happily refund your money.

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

    Rite Aid 44-485

    Rite Aid 44-485

  • INGREDIENTS AND APPEARANCE
    ALLERGY PLUS SINUS RELIEF 
    diphenhydramine hcl and phenylephrine hcl tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-0485
    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 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    HYPROMELLOSE, UNSPECIFIED (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:11822-0485-82 in 1 CARTON08/10/2005
    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 DrugM01208/10/2005
    Labeler - Rite Aid Corporation (014578892)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837manufacture(11822-0485) , pack(11822-0485)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(11822-0485)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.117025878manufacture(11822-0485)