Label: NIGHTTIME SLEEP AID tablet

  • NDC Code(s): 69168-439-06, 69168-439-40, 69168-439-84, 69168-439-98
  • Packager: Allegiant Health
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 16, 2023

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  • Active ingredient(s)

    Doxylamine succinate 25 mg

  • Purpose

    Nighttime sleep-aid

  • Use(s)

    helps to reduce difficulty in falling asleep

  • Warnings

    Do not use

    • in children under 12 years of age

    Ask a doctor before use if

    you have 

    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma
    • difficulty in urination due to an enlargement of the 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 2 weeks.
    Insomnia may be a symptom of a serious underlying medical illness.

    If pregnant or breastfeeding,

    ask a health professional before use.

    Keep out of reach of children

    Overdose Warning: 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 one tablet 30 minutes before going to bed; take
        once daily or as directed by a doctor

    Children under 12 years of age: do not use

  • Other information

    • DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
    • store at controlled room temperature 20°– 25°C (68°– 77°F)
    • use by expiration date on package
  • Inactive ingredients

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

  • Questions

    Call 1-888-952-0050 Monday through Friday 9AM - 5PM

  • Principal Display Panel

    Nighttime sleep aid

    Nighttime sleep aid


  • INGREDIENTS AND APPEARANCE
    NIGHTTIME SLEEP AID 
    nighttime sleep aid tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-439
    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
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVALSize10mm
    FlavorImprint Code 44;386
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69168-439-06120 in 1 BOTTLE; Type 0: Not a Combination Product05/16/2023
    2NDC:69168-439-842 in 1 CARTON05/16/2023
    28 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:69168-439-4040 in 1 BOTTLE; Type 0: Not a Combination Product11/06/2023
    4NDC:69168-439-98200 in 1 BOTTLE; Type 0: Not a Combination Product11/06/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA04056405/16/2023
    Labeler - Allegiant Health (079501930)
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