Label: ALLERGY- diphenhydramine hydrochloride capsule

  • NDC Code(s): 53943-113-01, 53943-113-03
  • Packager: DISCOUNT DRUG MART
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 17, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each capsule)

    Diphenhydramine HCl 25 mg

  • Purpose

    Antihistamine

  • Uses

    • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
      • runny nose
      • sneezing
      • itchy, watery eyes
      • itching of the nose or throat
    • temporarily relieves these symptoms due to the common cold:
      • runny nose
      • sneezing
  • Warnings

    Do not use with any other product containing diphenhydramine, even one used on skin

    Ask a doctor before use if you have

    • glaucoma
    • trouble urinating due to an enlarged 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

    • marked drowsiness may occur
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • excitability may occur, especially in children
    • be careful when driving a motor vehicle or operating machinery

    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

    • take every 4 to 6 hours
    • do not exceed 6 doses in 24 hours
    *
    12.5 mg dosage strength is not available in this package. Do not attempt to break capsules.
    adults and children 12 years of age and over25 mg to 50 mg (1 to 2 capsules)
    children 6 to under 12 years of age12.5 mg * to 25 mg (1 capsule)
    children under 6 years of ageask a doctor
  • Other information

    • store at room temperature 15°-30°C (59°-86°F)
    • protect from moisture
    • retain carton for complete product information
  • Inactive ingredients

    benzyl alcohol, butylparaben, D&C red #28, edible black ink, FD&C blue #1, FD&C red #40, gelatin, lactose, magnesium stearate, methylparaben, polysorbate 80, propylparaben, sodium lauryl sulfate

  • PRINCIPAL DISPLAY PANEL

    DISCOUNT drug mart FOOD FAIR

    †COMPARE TO THE ACTIVE INGREDIENT IN BENADRYL® ALLERGY KAPSEALS®

    ALLERGY

    Diphenhydramine HCl • Antihistamine 

    Temporary Relief of:

    • Sneezing

    • Runny Nose

    • Itchy, Watery Eyes

    • Itchy Throat

    24 CAPSULES - 25 mg each

    image description

  • INGREDIENTS AND APPEARANCE
    ALLERGY 
    diphenhydramine hydrochloride capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53943-113
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    Product Characteristics
    Colorpink, whiteScoreno score
    ShapeOVALSize14mm
    FlavorImprint Code A;20
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53943-113-012 in 1 CARTON11/30/2007
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:53943-113-031 in 1 CARTON11/30/2007
    2100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01211/30/2007
    Labeler - DISCOUNT DRUG MART (047741335)
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