SLEEP AID (DOXYLAMINE SUCCINATE) TABLET [SUPERVALU INC.]

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SLEEP AID (DOXYLAMINE SUCCINATE) TABLET [SUPERVALU INC.]
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NDC 41163-386-22
Set ID cb213889-10f0-402e-b093-a86491fc2a5b
Category HUMAN OTC DRUG LABEL
Packager SUPERVALU INC.
Generic Name
Product Class Antihistamine
Product Number
Application Number ANDA040564
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  • Active ingredient (in each tablet)

    Doxylamine succinate 25 mg

  • Purpose

    Nighttime sleep-aid

  • Use

    helps to reduce difficulty in falling asleep

  • Warnings

    Ask a doctor before use if you have

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

    Ask a doctor or pharmacist before use if you are

    taking any other drugs.

    When using this product

    • avoid alcoholic beverages
    • take only at bedtime 

    Stop use and ask a doctor if

    sleeplessness persists continuously for more than two 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: take one tablet 30 minutes before going to bed; take once daily or as directed by a doctor
    • do not give to children under 12 years of age 
  • Other information

    • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
    • store at controlled room temperature 20º-25ºC (68º-77ºF)
    • see end flap for expiration date and lot number 
  • Inactive ingredients

    dicalcium phosphate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

  • Questions or comments?

    Call 1-877-932-7948 24 hours a day, 7 days a week

  • Principal display panel

    EQUALINE®

    compare to Unisom® SleepTabs® active ingredient*

    NDC 41163-386-22

    nighttime
    sleep aid

    doxylamine succinate 25 mg
    (nighttime sleep aid)

    • fall asleep fast & safely
    • just one tablet per dose

    48 mini tablets

    TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

    DOES NOT CONTAIN GLUTEN

    *This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Unisom® SleepTabs®.
    50844    REV0513A38622

    DISTRIBUTED BY SUPERVALU INC.
    EDEN PRAIRIE, MN 55344 USA

    We're committed to your satisfaction and guarantee the quality of this product. Contact us at 1-877-932-7948, or www.supervalu-ourwnbrands.com.
    Please have package available.

    Equaline 44-386

    Equaline 44-386


  • INGREDIENTS AND APPEARANCE
    SLEEP AID 
    doxylamine succinate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-386
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorBLUEScore2 pieces
    ShapeOVALSize10mm
    FlavorImprint Code 44;386
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41163-386-223 in 1 CARTON04/11/200206/30/2022
    116 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA04056404/11/200206/30/2022
    Labeler - SUPERVALU INC. (006961411)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464PACK(41163-386)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894MANUFACTURE(41163-386)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305PACK(41163-386)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837PACK(41163-386)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088PACK(41163-386)
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