Label: MEDIQUE DIPHEN- diphenhydramine hydrochloride tablet, film coated

  • NDC Code(s): 47682-167-32, 47682-167-46, 47682-167-47, 47682-167-64, view more
    47682-184-32, 47682-184-46, 47682-184-47, 47682-184-64
  • 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 15, 2022

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  • SPL UNCLASSIFIED SECTION

    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 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

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

    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 a doctor or pharmacist before use if you are

    • taking sedatives or tranquilizers

    When using this product

    • marked drowsiness may occur
    • avoid alcohol beverages
    • alcohol, sedatives and tranquilizers may increase drowsiness
    • use caution 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 the reach of children.

    In case of overdose, contact a physician or poison control center right away (1-800-222-1222).

  • DOSAGE & ADMINISTRATION

    Directions

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

    Adults and children: (12 years and over) 1 to 2 caplets

    Children under 12 years: do not use

  • SPL UNCLASSIFIED SECTION

    Other information

    • store at room temperature 68º-77ºF (20º-25ºC)
    • protect from light
    • tamper-evident sealed 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

  • 184R Medique Diphen Label

    Collect MediBucks See inside flap for more details

    Medique®

    Diphen

    Hay Fever / Allergies

    Fiebre del Heno / Alergias

    This Package is for Households without Young Children.

    Este Paquete Es Para Hogares Sin Ninos Pequenos.

    Antihistamine • Diphenhydramine HCl 25 mg

    Antihistaminico • Hidrocloruro de Difenhidramina 25mg

    200 Caplets

    (200 x 1)

    Tamper Evident Unit Dose Packets

    Empaquetado con Sellado Evidente en Dosis Unitarias

    184R

  • Medique 167 Diphen Principal Display Panel

    Collect MediBucks See inside flap for more details

    Medique®

    Diphen

    Hay Fever / Allergies

    Fiebre del Heno / Alergias

    This Package is for Households without Young Children.

    Este Paquete Es Para Hogares Sin Ninos Pequenos.

    Antihistamine • Diphenhydramine HCl 25 mg

    Antihistaminico • Hidrocloruro de Difenhidramina 25mg

    200 Caplets

    (200 x 1)

    Tamper Evident Unit Dose Packets

    Empaquetado con Sellado Evidente en Dosis Unitarias

    Diphen

  • INGREDIENTS AND APPEARANCE
    MEDIQUE DIPHEN 
    diphenhydramine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-184
    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)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorpink (pink) Scoreno score
    ShapeOVAL (OVAL) Size11mm
    FlavorImprint Code 061;T
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47682-184-3212 in 1 BOX01/01/201211/01/2012
    1NDC:47682-184-461 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:47682-184-6424 in 1 BOX01/01/201208/01/2023
    21 in 1 PACKET; Type 0: Not a Combination Product
    3NDC:47682-184-47200 in 1 BOX01/01/201208/01/2023
    31 in 1 PACKET; Type 0: Not a Combination Product
    4NDC:47682-184-461 in 1 PACKET; Type 0: Not a Combination Product01/01/201208/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/01/201208/01/2023
    MEDIQUE DIPHEN 
    diphenhydramine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-167
    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
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorpink (pink) Scoreno score
    ShapeOVAL (OVAL) Size11mm
    FlavorImprint Code 048;D
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47682-167-3212 in 1 BOX01/01/201211/01/2012
    11 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:47682-167-6424 in 1 BOX01/01/2012
    21 in 1 PACKET; Type 0: Not a Combination Product
    3NDC:47682-167-47200 in 1 BOX01/01/2012
    3NDC:47682-167-461 in 1 PACKET; Type 0: Not a Combination Product
    4NDC:47682-167-461 in 1 PACKET; Type 0: Not a Combination Product01/01/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/01/2012
    Labeler - Unifirst First Aid Corporation (832947092)
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