Label: DIPHENHYDRAMINE HYDROCHLORIDE capsule

  • NDC Code(s): 54738-115-13, 54738-116-13
  • Packager: Richmond Pharmaceuticals Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 23, 2019

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  • Drug Facts

  • Active ingredient

    (in each capsule)

    Diphenhydramine HCl 25 mg

  • Purpose

    Antihistamine

  • Uses

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

    • runny nose
    • sneezing
    • itchy nose or throat
    • 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 to 2 capsules every 4 to 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
  • 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

  • Questions or comments? 

    call 804-270-4498, 8:30 am - 4:30 pm ET, Monday – Friday

    TAMPER EVIDENT: DO NOT USE IF BLISTER PACK IS TORN OR DAMAGED

    *Richmond Pharmaceuticals, Inc. is not affiliated with the owner of the trademark BENADRYL® Allergy.

    Distributed by: Richmond Pharmaceuticals Inc., Richmond, VA 23233 Made in USA

    RI1010

    Principle Display Panel

    Richmond Pharmaceuticals, Inc.

    *Compare to active ingredient in BENADRYL® Allergy

    Diphenhydramine HCI Capsules, USP

    25 mg
    50 mg

    ANTIHISTAMINE

    100 CAPSULES (10 x 10)

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HYDROCHLORIDE 
    diphenhydramine hydrochloride capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54738-115
    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 (pink, natural) Scoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code AP;20
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54738-115-13100 in 1 BOTTLE; Type 0: Not a Combination Product02/15/2000
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34102/15/2000
    DIPHENHYDRAMINE HYDROCHLORIDE 
    diphenhydramine hydrochloride capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54738-116
    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
    Colorpink (pink, pink) Scoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code AP;21
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54738-116-13100 in 1 BOTTLE; Type 0: Not a Combination Product02/15/2000
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34102/15/2000
    Labeler - Richmond Pharmaceuticals Inc. (043569607)
    Registrant - Advance Pharmaceutical Inc. (078301063)
    Establishment
    NameAddressID/FEIBusiness Operations
    Advance Pharmaceutical Inc.078301063manufacture(54738-115, 54738-116)
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