Label: DIPHENHYDRAMINE HCL 25 MG- diphenhydramine hcl tablet

  • NDC Code(s): 69618-025-01
  • 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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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each caplet)

    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 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 breating problem such as emphysema or chronic bronchitis
  • ASK DOCTOR/PHARMACIST

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

    Drug Facts continued on 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 breat-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 helo 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 over1 to 2 caplets
    children 6 to under 12 years1 caplet
    children under 6 yearsdo not use

  • Other information

    • each caplet contains: calcium 45 mg
    • store at room temperature
    • protect from moisture
  • Inactive ingredients

    croscarmellose sodium, D&C red #27, dicalcium phosphate, HPMC, magnesium stearate, microcrystalline cellulose, PEG, titanium dioxide

  • Questions or comments?

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

  • SPL UNCLASSIFIED SECTION

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

  • SPL UNCLASSIFIED SECTION

    *Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark BENADRYL®

    Distributed by: Reliable 1 Laboratories LLC

    Valley Stream, NY 11580

    www.reliable1labs.com

  • PRINCIPAL DISPLAY PANEL

    NDC 69618-025-01

    Diphenhydramine HCL 25 mg

    ANTIHISTAMINE

    100 CAPLETS

    *Compare to Active Ingredient in BENADRYL® ALLERGY

    Diphenhydramine 25 mg caplets

  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HCL 25 MG 
    diphenhydramine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69618-025
    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
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeOVALSize11mm
    FlavorImprint Code AP;135
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69618-025-01100 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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