Cvs 44-367

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (25 mg)

Inactive Ingredients

Starch, Corn Dibasic Calcium Phosphate Dihydrate Fd&c Blue No. 1 Aluminum Lake Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Silicon Dioxide Stearic Acid Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: 44;367 Shape: oval Color: blue Size: 11 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-07-09

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 caplets 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 caplet contains: calcium 30 mg
TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
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

corn starch, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide

Questions Or Comments?

1-800-426-9391

Principal Display Panel

CVS _™

NDC 51316-367-12

SLEEP-AID

Diphenhydramine HCl, 25 mg, Nighttime Sleep-Aid

Helps to reduce difficulty in falling asleep Non-Habit forming

Compare to simply sleep^®active ingredient*

100

MINI-CAPLETS

actual size

Does not

contain pain

reliever.

TAMPER EVIDENT: DO NOT USE IF

IMPRINTED SAFETY SEAL UNDER CAP

IS BROKEN OR MISSING

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2025 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

*This product is not manufactured or distributed by

Kenvue Inc., owner of the registered trademark

Simply Sleep®.

50844 ORG101936712

44-367

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 Caplet)

Diphenhydramine HCl 25 mg

Ask A Doctor Before Use If You Have

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

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 caplets 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 caplet contains: calcium 30 mg
TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
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)

corn starch, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel (Principal display panel)

CVS _™

NDC 51316-367-12

SLEEP-AID

Diphenhydramine HCl, 25 mg, Nighttime Sleep-Aid

Helps to reduce difficulty in falling asleep Non-Habit forming

Compare to simply sleep^®active ingredient*

100

MINI-CAPLETS

actual size

Does not

contain pain

reliever.

TAMPER EVIDENT: DO NOT USE IF

IMPRINTED SAFETY SEAL UNDER CAP

IS BROKEN OR MISSING

*This product is not manufactured or distributed by

Kenvue Inc., owner of the registered trademark

Simply Sleep®.

50844 ORG101936712

44-367

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 Caplet) (Active ingredient (in each caplet))

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
glaucoma
difficulty in urination due to enlargement of the prostate gland

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

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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 caplets 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 caplet contains: calcium 30 mg TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN 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": "corn starch, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide", "Questions or comments?": "1-800-426-9391", "Principal display panel": "CVS ™ NDC 51316-367-12 SLEEP-AID Diphenhydramine HCl, 25 mg, Nighttime Sleep-Aid Helps to reduce difficulty in falling asleep Non-Habit forming Compare to simply sleep ® active ingredient* 100 MINI-CAPLETS actual size Does not contain pain reliever. TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 © 2025 CVS/pharmacy CVS.com® 1-800-SHOP CVS *This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Simply Sleep®. 50844 ORG101936712 44-367", "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 caplet)": "Diphenhydramine HCl 25 mg", "Ask a doctor before use if you have": "a breathing problem such as emphysema or chronic bronchitis glaucoma difficulty in urination due to enlargement of the prostate gland", "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