SLEEP AID NIGHTTIME (DOXYLAMINE SUCCINATE) TABLET [CARDINAL HEALTH]

  • Home
  • SLEEP AID NIGHTTIME (DOXYLAMINE SUCCINATE) TABLET [CARDINAL HEALTH]

SLEEP AID NIGHTTIME (DOXYLAMINE SUCCINATE) TABLET [CARDINAL HEALTH]
PDF | XML
NDC 70000-0249-1
Set ID 08a0b7c4-40b2-4571-b699-de68bca81d17
Category HUMAN OTC DRUG LABEL
Packager Cardinal Health
Generic Name
Product Class Antihistamine
Product Number
Application Number ANDA040564
View All Sections
  • 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

    • a breathing problem such as asthma, emphysema or chronic bronchitis
    • glaucoma
    • 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

    • take only at bedtime
    • avoid alcoholic beverages

    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 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

  • Principal display panel

    LEADER™

    NDC 70000-0249-1

    Sleep Aid

    Doxylamine Succinate, 25 mg ι Nighttime Sleep-Aid

    Fall Asleep Fast
    One Tablet Per Dose
    Easy to Swallow

    32 TABLETS 

    ACTUAL SIZE

    COMPARE TO
    UNISOM® SLEEPTABS®
    active ingredient*

    100% Money
    Back Guarantee

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

    CIN 5315494 REV. 2/17

    CardinalHealth™

    DISTRIBUTED BY CARDINAL HEALTH
    DUBLIN, OHIO 43017
    www.myleader.com    1-800-200-6313
    Essential to Care™ since 1979

    ©2017 Cardinal Health. All Rights Reserved.
    CARDINAL HEALTH, the Cardinal Health LOGO,
    LEADER, and the Leader LOGO are trademarks
    or registered trademarks of Cardinal Health.

    All LEADER™ Brand Products Have A 
    100% Money Back Guarantee
    Return to place of purchase if not satisfied.

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

    50844  ORG051338627

    Leader 44-386

    Leader 44-386

  • INGREDIENTS AND APPEARANCE
    SLEEP AID  NIGHTTIME
    doxylamine succinate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0249
    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
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    Product Characteristics
    ColorBLUEScore2 pieces
    ShapeOVALSize10mm
    FlavorImprint Code 44;386
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0249-12 in 1 CARTON04/11/200202/03/2023
    116 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA04056404/11/200202/03/2023
    Labeler - Cardinal Health (097537435)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464PACK(70000-0249)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894MANUFACTURE(70000-0249)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837PACK(70000-0249)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305PACK(70000-0249)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088PACK(70000-0249)
View All Sections

Related Drugs

Search DailyMed Drugs