Label: DIPHENHYDRAMINE HYDROCHLORIDE capsule

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 2, 2023

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  • Drug Facts

    Active ingredient (in each capsule)
    Diphenhydramine HCl 25 mg

  • PURPOSE

    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

  • WARNINGS

     to make a child sleepy

     with any other product containing diphenhydramine, even one used on skin

    Ask a doctor before use if you have
     a breathing problem such as emphysema or chronic bronchitis

     glaucoma
     trouble urinating due to an enlarged prostate gland

    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

     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 doses in 24 hours

    adults and children
    12 years of age and over     		1 to 2 capsules
    children 6 to
    under 12 years of age     		1 capsule
    children under 6 years of agedo not use this product
    in children under 6 years of age

  • Other information

     store in a dry place at 15° – 30°C (59° – 86°F)

  • INACTIVE INGREDIENT

    corn starch, D&C red #28, FD&C blue #1, FD&C red #40, gelatin, lactose monohydrate, magnesium stearate, sodium lauryl sulfate

  • Questions or comments?

    1-800-616-2471

  • SPL UNCLASSIFIED SECTION

    TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING FROM BOTTLE.

  • HOW SUPPLIED

    HOW SUPPLIED: Diphenhydramine HCL capsules are available as follows:

    NDC 72789-317-10 Bottles of 10

    NDC 72789-317-12 Bottles of 12

    NDC 72789-317-15 Bottles of 15

    NDC 72789-317-20 Bottles of 20

    NDC 72789-317-30 Bottles of 30

  • PRINCIPAL DISPLAY PANEL

    72789317 Label
  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HYDROCHLORIDE 
    diphenhydramine hydrochloride capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72789-317(NDC:0904-7237)
    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
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    GELATIN (UNII: 2G86QN327L)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    Colorpink (Half pink and half clear with white powder inside and sealed with red band) Scoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code CPC;835
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72789-317-1010 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/05/2023
    2NDC:72789-317-1212 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/05/2023
    3NDC:72789-317-1515 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/05/2023
    4NDC:72789-317-2020 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/05/2023
    5NDC:72789-317-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/05/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01204/14/2022
    Labeler - PD-Rx Pharmaceuticals, Inc. (156893695)
    Registrant - PD-Rx Pharmaceuticals, Inc. (156893695)
    Establishment
    NameAddressID/FEIBusiness Operations
    PD-Rx Pharmaceuticals, Inc.156893695repack(72789-317)
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