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

Drug Label Information

Updated November 18, 2024

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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 DrugM01201/01/201208/01/2023
    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 DrugM01201/01/2012
    Labeler - Unifirst First Aid Corporation (832947092)
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