Label: ALLERGY RELIEF- diphenhydramine hydrochloride tablet, film coated

  • NDC Code(s): 0363-0100-61, 0363-0100-65
  • Packager: WALGREENS
  • 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 December 28, 2021

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  • DRUG FACTS

  • ACTIVE INGREDIENT

    Active ingredient (in each caplet)

    Diphenhydramine HCl 25 mg

  • PURPOSE

    Purpose

    Antihistamine

  • INDICATIONS & USAGE

    Uses

    temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

    • runny nose
    • itchy, watery eyes
    • sneezing
    • Itching of the nose or throat

    temporarily relieves these symptoms due to the common cold:

    • runny nose
    • sneezing
  • WARNINGS

    Warnings

    Ask a doctor before use if you have

    • glaucoma
    • trouble urinating due to enlarged prostrate gland
    • a breathing problem such as emphysema or chronic bronchitis

    Do not use

    • to make a child sleepy
    • with any other product containing diphenhydramine, even one used on skin

    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
    • excitability may occur, especially in children
    • be careful when driving a motor vehicle or operating machinery
  • 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. (1-800-222-1222)

  • DOSAGE & ADMINISTRATION

    Directions

    • Take every 4 to 6 hours, or as directed by a doctor
    • do not take more than 6 times in 24 hours

    adults and children 12 years of age and over: 1 to 2 caplets

    children 6 to under 12 years of age: 1 caplet

    children under 6 years of age: do not use

  • OTHER SAFETY INFORMATION

    Other information

    • each caplet contains: calcium 25 mg
    • protect from light
    • Store between 20-25°C (68-77° F)
    • use by expiration date on package
  • INACTIVE INGREDIENT

    Inactive ingredients carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C red #27 aluminum lake, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polysorbate 80, titanium dioxide

  • QUESTIONS

  • PRINCIPAL DISPLAY PANEL

    160R-Walgreens-Allergy-Relief-bottle-label-365s160R-Wagreens-Allergy-Relief-bottle-label-600s

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    diphenhydramine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0100
    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
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeCAPSULESize11mm
    FlavorImprint Code T061
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0100-65365 in 1 BOTTLE; Type 0: Not a Combination Product12/31/2021
    2NDC:0363-0100-61600 in 1 BOTTLE; Type 0: Not a Combination Product12/31/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/31/2021
    Labeler - WALGREENS (008965063)
    Registrant - TIME CAP LABORATORIES, INC. (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    TIME CAP LABORATORIES, INC.037052099manufacture(0363-0100)
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