Label: WAL-SOM- diphenhydramine hydrochloride tablet

  • 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 August 22, 2012

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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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