Label: DIPHENHYDRAMINE HCL capsule

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

Drug Label Information

Updated March 12, 2024

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  • Active ingredient (in each capsule)

    Diphenhydramine HCl 25mg

    Purpose

    Antihistamine

  • Uses

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

    Do not use

    • to make child sleepy
    • with any other product containing diphenhydramine, even one used on skin
  • Ask a doctor before use if you have

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

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers

  • When using this product

    • avoid alcoholic drinks
    • marked drowsiness may occur
    • excitability may occur, especially in children
    • alcohol, sedatives and tranquilizers may increase drowsiness
    • 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 immediately (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
    • 12.5 mg dosage strength is not available in this bottle.
    • Do not attempt to break capsule.
    adults and children 12 years of age and over25 mg to 50 mg (1-2 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

    • Tamper Evident: Do not use if safety seal is broken or missing from bottle.
    • store between 20°-25°C (68°-77°F) 
    • protect from excessive moisture
    • use by expiration date on bottle
  • Inactive ingredients

    black iron oxide, D&C red #28, D&C blue #1, FD&C red #40, gelatin, lactose monohydrate, magnesium stearate, silicon dioxide, sodium lauryl sulfate

  • Questions?

    Adverse drug event call (866)562-2756 Mon - Fri 8 AM to 4 PM

  • PRINCIPAL DISPLAY PANEL

    Diphenhydramine HCl 25mg

    55289479 Label

  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HCL 
    diphenhydramine hcl capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55289-479(NDC:16103-348)
    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
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    Product Characteristics
    Colorpink (PINK (clear) , WHITE (clear) , RED (band)) Scoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code PH014
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55289-479-1010 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/27/2021
    2NDC:55289-479-1212 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/27/2021
    3NDC:55289-479-1515 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/27/2021
    4NDC:55289-479-2020 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/27/2021
    5NDC:55289-479-2424 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/27/2021
    6NDC:55289-479-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/11/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01202/01/2016
    Labeler - PD-Rx Pharmaceuticals, Inc. (156893695)
    Registrant - PD-Rx Pharmaceuticals, Inc. (156893695)
    Establishment
    NameAddressID/FEIBusiness Operations
    PD-Rx Pharmaceuticals, Inc.156893695repack(55289-479)
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