Label: ALLERGY RELIEF- diphenhydramine hydrochloride tablet

  • NDC Code(s): 69842-264-62, 69842-264-67, 69842-264-79
  • Packager: CVS Pharmacy
  • 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 June 27, 2023

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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 and the common cold
  • 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

    1 to 2 tablets

    children 6 to under 12 years

    1 tablet

    children under 6 years

    do not use
  • Other information

    •
    each tablet contains: calcium 20 mg
    •
    store at 20-25°C (68-77°F). Avoid high humidity. Protect from light.
  • Inactive ingredients

    carnauba wax, crospovidone, D&C red no. 27 aluminum lake, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid, titanium dioxide

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    CVS Health™

    Compare to the active ingredient in Benadryl® Allergy Tablets

    Allergy Relief

    DIPHENHYDRAMINE HCl, 25 mg

    Antihistamine

    Relief of:

    • Sneezing

    • Runny nose

    • Itchy, watery eyes

    • Itchy throat

    400 TABLETS

    allergy relief image
  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    diphenhydramine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-264
    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)  
    CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    Product Characteristics
    ColorPINK (dark) Scoreno score
    ShapeOVALSize10mm
    FlavorImprint Code L479;25
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-264-6224 in 1 CARTON08/19/201602/29/2020
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:69842-264-6748 in 1 CARTON08/19/201602/29/2020
    21 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:69842-264-79400 in 1 BOTTLE; Type 0: Not a Combination Product06/27/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/19/2016
    Labeler - CVS Pharmacy (062312574)
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