NIGHTTIME SLEEP AID tablet

Nighttime Sleep Aid by

Drug Labeling and Warnings

Nighttime Sleep Aid by is a Otc medication manufactured, distributed, or labeled by Allegiant Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

NIGHTTIME SLEEP AID 
nighttime sleep aid tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69168-439
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	25 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	blue	Score	no score
Shape	OVAL	Size	10mm
Flavor		Imprint Code	44;386
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69168-439-06	120 in 1 BOTTLE; Type 0: Not a Combination Product	05/16/2023
2	NDC: 69168-439-84	2 in 1 CARTON	05/16/2023
2		8 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 69168-439-40	40 in 1 BOTTLE; Type 0: Not a Combination Product	11/06/2023
4	NDC: 69168-439-98	200 in 1 BOTTLE; Type 0: Not a Combination Product	11/06/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA040564	05/16/2023

Labeler - Allegiant Health (079501930)