Label: MEDIQUE AT HOME DIPHEN- diphenhydramine hcl tablet, film coated

  • NDC Code(s): 47682-166-50
  • Packager: Unifirst First Aid Corporation
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 8, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each caplet)

    Diphenhydramine Hydrochloride 25 mg

  • PURPOSE

    Purpose

    Antihistamine

  • INDICATIONS & USAGE

    Uses

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

    ■ runny nose ■ sneezing ■ itching of the nose or throat ■ itchy, watery eyes

    ■ temporarily relieves these symptoms due to the common cold

    ■ runny nose ■ sneezing

  • WARNINGS

    Warnings

  • DO NOT USE

    Do not use

    ■ to make a child sleepy

    ■ with any other product containing diphenhydramine, even one that is used on skin.

  • ASK DOCTOR

    Ask a doctor before use if you have

    ■ a breathing problem such as emphysema or chronic bronchitis

    ■ trouble urinating due to an enlarged prostate gland

    ■ glaucoma

  • ASK DOCTOR/PHARMACIST

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

  • WHEN USING

    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

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the 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 children12 years and over 1 to 2 caplets

    Children 6 to under 12 years 1 caplet

    Children under 6 years do not use

  • OTHER SAFETY INFORMATION

    Other information

    ■ store at room temperature 68º-77ºF (20º-25ºC)

    ■ protect from light

    TAMPER EVIDENT child resistant packets

    ■ do not use any opened or torn packets

  • INACTIVE INGREDIENT

    Inactive ingredients

    croscarmellose sodium, D&C red #27 aluminum lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide

  • QUESTIONS

    Questions or comments? 1-800-634-7680

  • PRINCIPAL DISPLAY PANEL

    Medique® @ Home

    Diphen Caplets

    Diphenhydramine HCl 25 mg

    Antihistamine

    Pull to Open

    Child-Resistant Packets

    *not actual size

    50 Packets

    (1 Caplet Per Packet)

    Compare to the active ingredient in Benadryl® Ultratab® Tablets

    MDQ

  • INGREDIENTS AND APPEARANCE
    MEDIQUE AT HOME DIPHEN 
    diphenhydramine hcl tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-166
    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
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeCAPSULESize11mm
    FlavorImprint Code 048;D
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47682-166-5050 in 1 BOX02/01/2021
    11 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01202/01/2021
    Labeler - Unifirst First Aid Corporation (832947092)