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Pill Identifier Information of Diphenhydramine Hydrochloride 50 MG Oral Capsule

Drug Information

Diphenhydramine Hydrochloride 50 MG Oral Capsule

Imprint: AP;021
Shape: C48336
Color: C48328
Ingredients: Diphenhydramine
Size: 14.00
Score: 1
Rxtty: SCD
Author: Advance Pharmaceutical Inc.
Inactive Ingredients: BENZYL ALCOHOL / BUTYLPARABEN / D&C RED NO. 28 / FD&C BLUE NO. 1 / FD&C RED NO. 40 / GELATIN / LACTOSE / MAGNESIUM STEARATE / METHYLPARABEN / POLYSORBATE 80 / PROPYLPARABEN / SODIUM LAURYL SULFATE>

Complete Information

  • Active Ingredient

    (in each capsule)

    Diphenhydramine HCl 50 mg

  • Purpose

    Antihistamine

  • Uses

    temporarily relieves these symptoms of hay fever or other upper respiratory allergies:

    • runny nose
    • itchy nose or throat
    • sneezing
    • itchy, watery eyes
  • 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

    • you may get very drowsy
    • avoid alcoholic drinks
    • alcohol, sedatives & 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.

  • Directions

    • adults and children 12 years and over: take 1 capsule every 4-6 hours; not more than 6 doses in 24 hours
    • children under 12 years: ask a doctor
  • Other Information

    • store at 15-30 °C (59-86 °F)
    • protect from moisture
    • For 1000 Count: THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN
  • Inactive Ingredients

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

  • Questions or Comments

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP OR BAND AROUND ANY CAPSULE IS MISSING OR DAMAGED

    Manufactured by: Advance Pharmaceutical Inc. Holtsville, NY 11742

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    47bb2ce7-figure-01

    47bb2ce7-figure-02

    DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, USP 50 MG

    ANTIHISTAMINE

    NDC: 17714-021-01 – 100 COUNT

    NDC: 17714-021-10 – 1000 COUNT (THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN)

  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HYDROCHLORIDE 
    diphenhydramine hydrochloride capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17714-021
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 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
    ColorpinkScoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code AP;021
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17714-021-01100 in 1 BOTTLE; Type 0: Not a Combination Product10/05/1989
    2NDC:17714-021-101000 in 1 BOTTLE; Type 0: Not a Combination Product10/05/1989
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/05/1989
    Labeler - Advance Pharmaceutical Inc. (078301063)
    Registrant - Advance Pharmaceutical Inc. (078301063)
    Establishment
    NameAddressID/FEIBusiness Operations
    Advance Pharmaceutical Inc.078301063manufacture(17714-021)