NIGHTTIME SLEEP AID- nighttime sleep aid tablet 
Allegiant Health

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439 - Nighttime Sleep Aid

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

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


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)

Revised: 3/2023
Document Id: 8accb0e9-d994-4b6a-acc3-4b416f3f65ba
Set id: 3761182c-275b-40f3-a262-9ef5f5a80723
Version: 3
Effective Time: 20230316
 
Allegiant Health