Label: ALLERGY RELIEF- diphenhydramine hydrochloride capsule

  • NDC Code(s): 83324-087-01, 83324-087-24
  • Packager: CHAIN DRUG MARKETING ASSOCIATION, INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated August 16, 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

    • to make a child sleepy
    • with any other product containing diphenhydramine, even one used on skin

    Ask a doctor before use if you have

    • glaucoma
    • a breathing problem such as emphysema or chronic bronchitis
    • trouble urinating due to an enlarged prostate gland

    Ask a doctor or pharmacist before use if you aretaking sedatives or tranquilizers

    When using this product

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

    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

    • take every 4 to 6 hours, or as directed by a doctor
    • do not take more than 6 times in 24 hours
    adults and children 12 years and over1 to 2 capsules
    children 6 to under 12 years1 capsule
    children under 6 yearsdo not use

  • Other information

    • store between 20-25°C (68-77°F)
    • 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

    QUALITY CHOICE®

    NDC 83324-087-01

    †Compare to Active Ingredient in BENADRYL® Allergy

    Allergy Relief

    Diphenhydramine HCl 25 mg

    Antihistamine

    For Relief of:

    Sneezing | Itchy, Watery Eyes | Runny Nose | Itchy Throat

    Actual Size

    100 CAPSULES

    image description

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    diphenhydramine hydrochloride capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83324-087
    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:83324-087-242 in 1 CARTON08/16/2024
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:83324-087-011 in 1 CARTON08/16/2024
    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 DrugM01208/16/2024
    Labeler - CHAIN DRUG MARKETING ASSOCIATION, INC. (011920774)
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