Label: DIPHENHYDRAMINE HCL 25 MG- diphenhydramine hcl capsule

  • NDC Code(s): 69618-024-01
  • Packager: Reliable 1 Laboratories LLC
  • 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 March 29, 2023

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  • Active ingredient (in each capsule)

    Diphenhydramine HCL 25 mg

  • Purpose

    Antihistamine

  • Uses

    temporarily releaves 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 otherprodcut containing diphenhydramine, even one use on skin
    • to make a child sleepy
  • ASK DOCTOR

    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 DOCTOR/PHARMACIST

    Ask a doctor or pharamcist before use if you are taking sedatives or tranquilizers

    Drug Facts continued of back of label

  • WHEN USING

    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
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    • take every 4-6 hours
    • do not take more than 6 doses in 24 hours

    adults and children 12 years and over

    1 to 2 capsules
    children 6 to under 12 years

    1 capsule
    children under 6 yearsdo not use

  • Other information

    • store at room temperature
    • protect from moisture
  • Inactive ingredients

    benzl alcohol, butylparaben, D&C red #28, edible black ink, FD&C blue #1, FD&C red #40, gelatin, lactose, magnesium stearate, methlyparaben, polysorbate 80, propylparaben, sodium lauryl sulfate

  • Questions or comments?

    call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday

  • SPL UNCLASSIFIED SECTION

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

  • SPL UNCLASSIFIED SECTION

    Distributed by: Reliable 1 Laboratories LLC

    Valley Stream, NY 11580

    www.reliable1labs.com

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • PRINCIPAL DISPLAY PANEL

    NDC 69618-024-01

    Diphenhydramine HCL 25 mg

    ANTIHISTAMINE

    100 CAPSULES

    DIPHENHYDRAMINE 25 CAPSULES

  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HCL 25 MG 
    diphenhydramine hcl capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69618-024
    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)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    GELATIN (UNII: 2G86QN327L)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    Colorpink (Half pink and half white) Scoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code AP;20
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69618-024-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/01/2015
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34111/01/2015
    Labeler - Reliable 1 Laboratories LLC (079718111)
    Registrant - Reliable 1 Laboratories LLC (079718111)
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