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
  • 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 March 17, 2022

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  • 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 finalpart34102/01/2021
    Labeler - Unifirst First Aid Corporation (832947092)
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