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Nighttime Sleepaid Prescribing Information

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

Medically reviewed by Drugs.com. Last updated on Oct 17, 2023.

Active ingredient (in each tablet)

Doxylamine succinate 25 mg

Purpose

Nighttime sleep-aid

Indications and Usage for Nighttime Sleepaid

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)

Nighttime Sleepaid Dosage and Administration

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

Storage and Handling

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

sleep-aid-image

NIGHTTIME SLEEP AID
doxylamine succinate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-441
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
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
Product Characteristics
ColorBLUEScore2 pieces
ShapeOVALSize10mm
FlavorImprint CodeL441
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-441-642 in 1 CARTON07/23/199701/01/2016
116 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:59779-441-6748 in 1 CARTON04/18/201811/30/2022
21 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:59779-441-011 in 1 CARTON05/09/2018
396 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA04016707/23/1997
Labeler - CVS Pharmacy (062312574)

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