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Nighttime Sleepaid

Package insert / prescribing information
Generic name: doxylamine succinate
Dosage form: tablet
Drug class: Miscellaneous anxiolytics, sedatives and hypnotics

Medically reviewed by Drugs.com. Last updated on Oct 1, 2021.

Active ingredient (in each tablet)

Doxylamine succinate 25 mg

Purpose

Nighttime sleep-aid

Use

helps to reduce difficulty in falling asleep

Warnings

Do not use

in children under 12 years of age

Ask 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

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 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 right away. (1-800-222-1222)

Directions

adults and children 12 years of age 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

store at 68°-77°F (20°-25°C)
retain in carton until time of use
see carton end panel for lot number and expiration date

Inactive ingredients

anhydrous dibasic calcium phosphate, dibasic calcium phosphate dihydrate, FD&C blue no. 1 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to the active ingredient in Unisom® SleepTabs®

Tablets

Nighttime

Sleep-Aid

DOXYLAMINE SUCCINATE TABLETS, 25 mg

Nighttime sleep-aid

Helps to reduce difficulty in falling asleep

Actual Size

Actual Bottle Size on Side Panel

96 TABLETS

One tablet per dose

NIGHTTIME SLEEP AID
doxylamine succinate tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-441
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE 25 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
FD&C BLUE NO. 1
Product Characteristics
Color BLUE Score 2 pieces
Shape OVAL Size 10mm
Flavor Imprint Code L441
Contains
Packaging
# Item Code Package Description
1 NDC:59779-441-64 2 BLISTER PACK in 1 CARTON
1 16 TABLET in 1 BLISTER PACK
2 NDC:59779-441-67 48 BLISTER PACK in 1 CARTON
2 1 TABLET in 1 BLISTER PACK
3 NDC:59779-441-01 1 BOTTLE in 1 CARTON
3 96 TABLET in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040167 07/23/1997
Labeler - CVS Pharmacy (062312574)
CVS Pharmacy