Walgreens 44-386

Drug Facts

Composition & Product

Active Ingredients

Doxylamine (25 mg)

Inactive Ingredients

Dibasic Calcium Phosphate Dihydrate Fd&c Blue No. 1 Aluminum Lake Magnesium Stearate Microcrystalline Cellulose Sodium Starch Glycolate Type A Potato

Identifiers & Packaging

Pill Appearance

Imprint: 44;386 Shape: oval Color: blue Size: 10 mm Score: 1

Marketing Status

ANDA Active Since 2024-04-05

Medication Information

Purpose

Nighttime sleep-aid

Description

Doxylamine succinate 25 mg

Use

helps to reduce difficulty in falling asleep

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

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

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

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.

Active Ingredient (in Each Tablet)

Doxylamine succinate 25 mg

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

Structured Label Content

Use

helps to reduce difficulty in falling asleep

Purpose

Nighttime sleep-aid

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

Do Not Use (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

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

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

Principal Display Panel (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®.

50844 ORG012338631

NDC 0363-0386-31

WALGREENS 44-386

When Using This Product (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 (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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away.

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Doxylamine succinate 25 mg

Ask A Doctor Before Use If You Have (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 (Ask a doctor or pharmacist before use if you are)

taking

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

Advanced Ingredient Data

[{"name": "DOXYLAMINE", "unii": "95QB77JKPL", "classCode": "ACTIB", "strengthNumerator": "25", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "DIBASIC CALCIUM PHOSPHATE DIHYDRATE", "unii": "O7TSZ97GEP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1 ALUMINUM LAKE", "unii": "J9EQA3S2JM", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A POTATO", "unii": "5856J3G2A2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "helps to reduce difficulty in falling asleep", "Purpose": "Nighttime sleep-aid", "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", "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", "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", "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.", "Active ingredient (in each tablet)": "Doxylamine succinate 25 mg", "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"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information