Label: ALLERGY ANTIHISTAMINE- diphenhydramine hydrochloride tablet

  • NDC Code(s): 59726-691-01, 59726-691-04, 59726-691-12, 59726-691-48
  • Packager: P & L Development, 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 October 26, 2021

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  • Active ingredient (in each tablet)

    Diphenhydramine HCl 25 mg

  • 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
    • temporarily relieves these symptoms due to the common cold:
      • runny nose
      • sneezing 
  • Warnings

    Do not use

    • 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 and over take 1 to 2 tablets 
    children 6 to under 12 years  take 1 tablet
    children under 6 years  do not use this
  • Other information

    • each tablet contains: calcium 25 mg
    • store between 20-25°C (68-77°F)
    • protect from light and moisture
  • Inactive ingredients

    carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C Red #27 Aluminum Lake, dibasic calcium phosphate dihydrate, hypromellose, lecithin*, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol*, purified water*, talc*, titanium dioxide

    * contains one or more of these ingredients

  • Questions or comments?

    Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

    Compare to the active ingredient in Benadryl® Allergy**

    Allergy relief

    Diphenhydramine HCl, 25 mg

    Antihistamine

    for allergy relief

    • runny nose
    • sneezing
    • itchy, watery eyes
    • Itchy nose or throat

    TABLETS

    †This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Benadryl® Allergy.

    TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    Distributed by:

    PL Developments

    200 Hicks Street

    Westbury, NY  11590

  • Product Label

    Diphenhydramine HCI 25 mg

    ReadyinCase Allergy Relief

  • INGREDIENTS AND APPEARANCE
    ALLERGY  ANTIHISTAMINE
    diphenhydramine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59726-691
    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
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeCAPSULESize12mm
    FlavorImprint Code T;061;V;25;S4
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59726-691-122 in 1 CARTON08/27/201301/05/2024
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:59726-691-011 in 1 BOX08/27/201301/05/2024
    2100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:59726-691-04400 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/27/201301/05/2024
    4NDC:59726-691-4848 in 1 CARTON08/27/201301/05/2024
    41 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/27/201301/05/2024
    Labeler - P & L Development, LLC (800014821)
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