Walgreens 44-189

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (25 mg)

Inactive Ingredients

Croscarmellose Sodium Dibasic Calcium Phosphate Dihydrate Fd&c Blue No. 1 Aluminum Lake Magnesium Stearate Microcrystalline Cellulose Silicon Dioxide Stearic Acid

Identifiers & Packaging

Pill Appearance

Imprint: 44;189 Shape: round Color: blue Size: 10 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 1990-04-10 Until 2022-02-13

Medication Information

Purpose

Nighttime sleep-aid

Description

Diphenhydramine HCl 25 mg

Uses

for relief of occasional sleeplessness
reduces time to fall asleep if you have difficulty falling asleep

Directions

do not take more than directed
adults and children 12 years and over: take 2 tablets at bedtime if needed or as directed by a doctor
children under 12 years: do not use

Do Not Use

for children under 12 years of age
with any other product containing diphenhydramine, even one used on skin

Other Information

each tablet contains: calcium 60 mg
protect from moisture
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
see end flap for expiration date and lot number

Inactive Ingredients

croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid

Questions Or Comments?

1-800-426-9391

Principal Display Panel

Walgreens

WALGREENS PHARMACIST RECOMMENDED^†

Compare to the active ingredient

in Original Formula Sominex®^††

NDC 0363-0189-46

NIGHTTIME SLEEP AID

Sleep II

DIPHENHYDRAMINE HCl 25 mg /

NIGHTTIME SLEEP AID

Nighttime

96 TABLETS

ACTUAL SIZE

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

100% SATISFACTION GUARANTEED

walgreens.com ©2021 Walgreen Co.

50844 ORG101918946

^†Our pharmacists recommend the Walgreens brand.

We invite you to compare to national brands.

^††This product is not manufactured or distributed by

Medtech Products Inc., owner of the registered

trademark Original Formula Sominex®.

Walgreens 44-189

When Using This Product

avoid alcoholic beverages.

Stop Use and Ask A Doctor If

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a 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)

Diphenhydramine HCl 25 mg

Ask A Doctor Before Use If You Have

a breathing problem such as emphysema or chronic bronchitis
difficulty in urination due to enlargement of the prostate gland
glaucoma

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers.

Structured Label Content

Uses

for relief of occasional sleeplessness
reduces time to fall asleep if you have difficulty falling asleep

Purpose

Nighttime sleep-aid

Directions

do not take more than directed
adults and children 12 years and over: take 2 tablets at bedtime if needed or as directed by a doctor
children under 12 years: do not use

Do Not Use (Do not use)

for children under 12 years of age
with any other product containing diphenhydramine, even one used on skin

Other Information (Other information)

each tablet contains: calcium 60 mg
protect from moisture
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
see end flap for expiration date and lot number

Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel

Walgreens

WALGREENS PHARMACIST RECOMMENDED^†

Compare to the active ingredient

in Original Formula Sominex®^††

NDC 0363-0189-46

NIGHTTIME SLEEP AID

Sleep II

DIPHENHYDRAMINE HCl 25 mg /

NIGHTTIME SLEEP AID

Nighttime

96 TABLETS

ACTUAL SIZE

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

100% SATISFACTION GUARANTEED

walgreens.com ©2021 Walgreen Co.

50844 ORG101918946

^†Our pharmacists recommend the Walgreens brand.

We invite you to compare to national brands.

^††This product is not manufactured or distributed by

Medtech Products Inc., owner of the registered

trademark Original Formula Sominex®.

Walgreens 44-189

When Using This Product (When using this product)

avoid alcoholic beverages.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a 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))

Diphenhydramine HCl 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
difficulty in urination due to enlargement of the prostate gland
glaucoma

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

taking sedatives or tranquilizers.

Advanced Ingredient Data

[{"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "25", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"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": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "for relief of occasional sleeplessness reduces time to fall asleep if you have difficulty falling asleep", "Purpose": "Nighttime sleep-aid", "Directions": "do not take more than directed adults and children 12 years and over: take 2 tablets at bedtime if needed or as directed by a doctor children under 12 years: do not use", "Do not use": "for children under 12 years of age with any other product containing diphenhydramine, even one used on skin", "Other information": "each tablet contains: calcium 60 mg protect from moisture store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number", "Inactive ingredients": "croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid", "Questions or comments?": "1-800-426-9391", "Principal Display Panel": "Walgreens WALGREENS PHARMACIST RECOMMENDED † Compare to the active ingredient in Original Formula Sominex® †† NDC 0363-0189-46 NIGHTTIME SLEEP AID Sleep II DIPHENHYDRAMINE HCl 25 mg / NIGHTTIME SLEEP AID Nighttime 96 TABLETS ACTUAL SIZE TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING DISTRIBUTED BY: WALGREEN CO. 200 WILMOT RD., DEERFIELD, IL 60015 100% SATISFACTION GUARANTEED walgreens.com ©2021 Walgreen Co. 50844 ORG101918946 † Our pharmacists recommend the Walgreens brand. We invite you to compare to national brands. †† This product is not manufactured or distributed by Medtech Products Inc., owner of the registered trademark Original Formula Sominex®. Walgreens 44-189", "When using this product": "avoid alcoholic beverages.", "Stop use and ask a doctor if": "sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a 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)": "Diphenhydramine HCl 25 mg", "Ask a doctor before use if you have": "a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland glaucoma", "Ask a doctor or pharmacist before use if you are": "taking sedatives or tranquilizers."}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information