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
glaucoma
trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

taking

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

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

Walgreens

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®.

50844 ORG012338631 NDC 0363-0386-31

WALGREENS 44-386

SLEEP AID
doxylamine succinate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-0386
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0363-0386-31	1 in 1 CARTON	04/05/2024
1		80 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

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

Labeler - Walgreen Company (008965063)

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

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

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

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

Walgreens 44-386