SLEEP AID- doxylamine succinate tablet

Sleep Aid by

Drug Labeling and Warnings

Sleep Aid by is a Otc medication manufactured, distributed, or labeled by Walgreen Company, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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
• with any other product containing doxylamine
• unless you have time for a full night’s sleep

Ask a doctor before use if you have

• a breathing problem such as emphysema or chronic bronchitis
• trouble urinating due to an enlarged prostate gland
• glaucoma

Ask a doctor or pharmacist before use if you are

taking

• any other drugs
• sedatives or any other sleep-aid
• any other antihistamines
• tranquilizers

When using this product

• avoid alcoholic beverages
• do not drive a motor vehicle or operate machinery
• 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.

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 controlled room temperature 20°-25°C (68°-77°F)
• see end flap for expiration date and lot number

Inactive ingredients

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

Questions or comments?

Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

Principal display panel

VALUE SIZE

Walgreens

WALGREENS PHARMACIST RECOMMENDED†

Compare to the active ingredient
in Unisom® SleepTabs®††

Sleep Aid
DOXYLAMINE SUCCINATE TABLETS,
25 mg / NIGHTTIME SLEEP-AID
Nighttime

80
TABLETS

ONE TABLET PER DOSE

ACTUAL SIZE

TAMPER EVIDENT: DO NOT USE IF
IMPRINTED SAFETY SEAL UNDER CAP IS
BROKEN OR MISSING

†Our pharmacists recommend the
Walgreens brand. We invite you to
compare to national brands.
††This product is not manufactured
or distributed by Chattem, Inc.,
owner of the registered trademark
Unisom® SleepTabs®.

DISTRIBUTED BY: WALGREEN CO.
DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED
walgreens.com ©2023 Walgreen Co.

50844    ORG012338631

NDC: 0363-0386-31

WALGREENS 44-386

INGREDIENTS AND APPEARANCE

SLEEP AID 
doxylamine succinate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-0386
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: 0363-0386-22	3 in 1 CARTON	04/05/2024
1		16 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 0363-0386-31	1 in 1 CARTON	04/05/2024
2		80 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3	NDC: 0363-0386-12	1 in 1 CARTON	12/31/2024
3		100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA040564	04/05/2024

Labeler - Walgreen Company (008965063)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	pack(0363-0386)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	manufacture(0363-0386) , pack(0363-0386)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	pack(0363-0386)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		117025878	manufacture(0363-0386)