WAL SOM NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) CAPSULE [WALGREEN COMPANY]

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  • WAL SOM NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) CAPSULE [WALGREEN COMPANY]

WAL SOM NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) CAPSULE [WALGREEN COMPANY]
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NDC 0363-0682-11
Set ID 93b010a8-85af-4beb-8960-19291a1a0332
Category HUMAN OTC DRUG LABEL
Packager Walgreen Company
Generic Name
Product Class
Product Number
Application Number PART338
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  • Active ingredient (in each mini-capsule)

    Diphenhydramine HCl 25 mg

  • Purpose

    Nighttime sleep-aid

  • Use

    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
    • difficulty in urination due to enlargement of the prostate gland

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers.

    When using this product

    avoid alcoholic beverages.

    Stop use and ask a doctor if

    sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a 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 Control Center (1-800-222-1222) right away.

  • Directions

    • adults and children 12 years and over: take 2 mini-capsules (50 mg) at bedtime if needed, or as directed by a doctor
  • Other information

    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • see end flap for expiration date and lot number
    • protect from moisture
  • Inactive ingredients

    butylparaben, corn starch, FD&C blue #1, FD&C red #3, gelatin, lactose, magnesium stearate, methylparaben, polysorbate 80, povidone, propylene glycol, propylparaben, shellac, silicon dioxide, sodium hydroxide, titanium dioxide

  • Questions or comments?

     1-800-426-9391

  • Principal display panel

    Well at
    Walgreens
    WALGREENS PHARMACIST RECOMMENDED‡

    NIGHTTIME SLEEP AID
    Wal-Som®
    Diphenhydramine HCl 25 mg /
    Nighttime Sleep Aid
    • Easy to swallow
    • Non-habit forming

    60
    MINI-CAPSULES

    Actual Size

    Compare to Unisom® SleepMinis™ active ingredient‡‡

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING OR IF BLUE BAND AROUND CAPSULE IS BROKEN OR MISSING

    †Walgreens Pharmacist Survey
    Study, November 2014
    ‡‡This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Unisom® SleepMinis™.
    50844    REV0216A68211
    Walgreens 44-682

    Walgreens 44-682

  • INGREDIENTS AND APPEARANCE
    WAL SOM  NIGHTTIME SLEEP AID
    diphenhydramine hcl capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0682
    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
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
    GELATIN (UNII: 2G86QN327L)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SHELLAC (UNII: 46N107B71O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBLUE (blue and blue banded) Scoreno score
    ShapeOVALSize14mm
    FlavorImprint Code 44;682
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0682-111 in 1 CARTON07/31/201603/18/2022
    160 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33807/31/201603/18/2022
    Labeler - Walgreen Company (008965063)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464PACK(0363-0682)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088MANUFACTURE(0363-0682) , PACK(0363-0682)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305PACK(0363-0682)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837PACK(0363-0682)
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