WAL-SOM (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [WALGREEN ]

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WAL-SOM (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [WALGREEN ]
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NDC 0363-0223-01, 0363-0223-02
Set ID 21f18921-e0d7-42ad-8a62-e912711aa8a3
Category HUMAN OTC DRUG LABEL
Packager Walgreen
Generic Name
Product Class
Product Number
Application Number PART338
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  • Active ingredient

    Diphenhydramine HCl 25mg
  • Purpose

    Nighttime Sleep-aid

  • Uses

    For relief of occasional sleeplessness

  • Warnings


    Do not use

    • For children under 12 years of age
    • With any other product containing Diphenhydramine, even one used on skin

    Ask a doctor before use if you have

    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma
    • trouble urinating due to an enlarged prostate gland

    Ask a doctor or pharmacist before use if you are

    • Taking sedatives or tranquilizers

    While using this product

    avoid alcoholic drinks

    Stop use and ask a doctor if

    sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

    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 center (1-800-222-1222) right away
  • Directions

    Adults and children 12 years of age and over:

    • 2 Rapidmelt (25mg each) at bedtime if needed, or as directed by a doctor
    • Place 2 tablets on to tongue; tablets dissolve with or without water
    • allow tablets to dissolve in mouth or chew before swallowing
  • Other information

    • Each tablet contains Sodium 5mg
    • Do not use if carton is opened or blister unit is broken
    • Store between 20-25 °C(68-77°F). Avoid high humidity. Protect from light.
    • See side panel for lot number and expiration date
  • Inactive ingredients

    crospovidone, D&C Red No 7 calcium lake, ethyl cellulose, flavor, magnesium stearate, maltodextrin, mannitol, microcrystalline cellulose, modified food starch, silicon dioxide, sodium lauryl sulfate, sodium polystyrene sulfonate, sodium starch glycolate, sucralose

  • Question or comments?

     Call toll free 1--800-walgreens

  • Principal display panel

    NEW

    QUICK DISSOLVING

    NIGHTTIME SLEEP AID

    WELL AT WALGREENS

    WALGREENS PHARMACIST RECOMMENDED

    WAL-SOM

    DIPHENHYDRAMINE HCL TABLETS 25MG

    RAPIDMELT/ SLEEP AID

    SAFE, NON-HABIT FORMING, FALL ASLEEP FASTER, SLEEP SOUNDLY, WAKE UP REFRESHED

    24 QUICK DISSOLVING TABLETS

    COMPARE TO UNISOM SLEEPMELTS ACTIVE INGREDIENT

    DO NOT SWALLOW WHOLE TABLET

    Carton image

  • INGREDIENTS AND APPEARANCE
    WAL-SOM  
    diphenhydramine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0223
    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
    CROSPOVIDONE (UNII: 68401960MK)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MANNITOL (UNII: 3OWL53L36A)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM POLYSTYRENE SULFONATE (UNII: 1699G8679Z)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)  
    Product Characteristics
    Colorpink (pink color) Scoreno score
    ShapeROUND (Round lozenge shaped) Size14mm
    FlavorCHERRY (Cherry flavor) Imprint Code CP223
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0223-024 in 1 CARTON
    1NDC:0363-0223-016 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33808/22/2012
    Labeler - Walgreen (008965063)
    Registrant - Capricorn Pharma Inc. (041704524)
    Establishment
    NameAddressID/FEIBusiness Operations
    Capricorn Pharma Inc.041704524manufacture(0363-0223) , analysis(0363-0223) , pack(0363-0223) , label(0363-0223)
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