2834-cvs

2834-cvs
SPL v4
SPL
SPL Set ID 6e0f7ab7-eb1e-9a19-e053-2991aa0a6d1f
Route
ORAL
Published
Effective Date 2019-01-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Light Mineral Oil Titanium Dioxide Triacetin Calcium Phosphate, Dibasic, Dihydrate Fd&c Blue No. 1 Microcrystalline Cellulose Silicon Dioxide Stearic Acid Magnesium Stearate Talc Croscarmellose Hypromelloses

Identifiers & Packaging

Pill Appearance
Imprint: CPC;2824 Shape: oval Color: blue Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-07-23
Description

Active ingredient (in each caplet) Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Medication Information

Purpose

Nighttime sleep-aid

Description

Active ingredient (in each caplet) Diphenhydramine HCl 25 mg

Use

for relief of occasional sleeplessness

Section 34088-5

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 42229-5

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

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark

Simply Sleep®.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2018 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

V-34571

Section 51945-4

CVSHealth

Compare to the active ingredient in Simply Sleep®*

Nighttime

Sleep-Aid

DIPHENHYDRAMINE HCl, 25 mg

Nighttime sleep-aid

• Safe, non-habit forming

• Fall asleep fast, wake up rested

• Does not contain pain reliever

500 MINI-CAPLETS

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

■ in children under 12 years of age

■ with any other product containing diphenhydramine, even one used on skin

Drug Facts

Active ingredient (in each caplet)

Diphenhydramine HCl 25 mg

Other Information

■ each caplet contains: calcium 37 mg

■ store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

■ protect from moisture

■ use by expiration date on package

Inactive Ingredients

croscarmellose sodium, dicalcium phosphate, FD&C blue #1 lake, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, silica, stearic acid, talc, titanium dioxide, triacetin

Questions Or Comments?

1-800-231-4670

When Using This Product

■ use caution when driving a motor vehicle or operating machinery ■ drowsiness will occur

■ 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.

Ask A Doctor Before Use If You Have

■ glaucoma

■ a breathing problem such as emphysema or chronic bronchitis

■ 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

Use

for relief of occasional sleeplessness

Section 34088-5 (34088-5)

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 42229-5 (42229-5)

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

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark

Simply Sleep®.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2018 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

V-34571

Section 51945-4 (51945-4)

CVSHealth

Compare to the active ingredient in Simply Sleep®*

Nighttime

Sleep-Aid

DIPHENHYDRAMINE HCl, 25 mg

Nighttime sleep-aid

• Safe, non-habit forming

• Fall asleep fast, wake up rested

• Does not contain pain reliever

500 MINI-CAPLETS

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)

■ in children under 12 years of age

■ with any other product containing diphenhydramine, even one used on skin

Drug Facts

Active ingredient (in each caplet)

Diphenhydramine HCl 25 mg

Other Information (Other information)

■ each caplet contains: calcium 37 mg

■ store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

■ protect from moisture

■ use by expiration date on package

Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, dicalcium phosphate, FD&C blue #1 lake, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, silica, stearic acid, talc, titanium dioxide, triacetin

Questions Or Comments? (Questions or comments?)

1-800-231-4670

When Using This Product (When using this product)

■ use caution when driving a motor vehicle or operating machinery ■ drowsiness will occur

■ 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.

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

■ glaucoma

■ a breathing problem such as emphysema or chronic bronchitis

■ 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

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:38.516563 · Updated: 2026-03-14T23:05:32.543899