Label: DIPHENHYDRAMINE- diphenhydramine hydrochloride tablet, coated

  • NDC Code(s): 57344-090-02, 57344-090-03
  • Packager: AAA Pharmaceutical, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 2, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • 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 with any other product containing diphenhydramine, even one used on skin

    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 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

    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.

  • Directions

    • take every 4 to 6 hours
    • do not exceed 6 doses in 24 hours
    *
    12.5 mg dosage strength is not available in this package. Do not attempt to break tablets.
    adults and children 12 years of age and over25 mg to 50 mg (1 to 2 tablets)
    children 6 to under 12 years of age12.5 mg * to 25 mg (1 tablet)
    children under 6 years of ageask a doctor
  • Other information

    • each tablet contains: calcium 45 mg
    • store at room temperature 15°-30°C (59°-86°F)
    • retain carton for complete product information
  • Inactive ingredients

    colloidal silicon dioxide, croscarmellose sodium, D&C red #27, dibasic calcium phosphate, FD&C yellow #6, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

  • PRINCIPAL DISPLAY PANEL

    RESTORE U

    NDC 57344-090-02

    †COMPARE TO THE ACTIVE INGREDIENT IN BENADRYL® ALLERGY ULTRATABS®

    Allergy Relief

    Antihistamine 
    Diphenhydramine HCl

    Easy To Swallow

    Relieves: • Sneezing • Runny Nose 
    • Itchy, Watery Eyes • Itchy Throat

    48 TABLETS

    image description

  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE 
    diphenhydramine hydrochloride tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57344-090
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeOVALSize11mm
    FlavorImprint Code 25;052
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57344-090-024 in 1 CARTON04/13/2012
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:57344-090-031 in 1 CARTON11/27/2017
    2100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01204/13/2012
    Labeler - AAA Pharmaceutical, Inc. (181192162)
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