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
Purpose

Nighttime sleep-aid

Description

Active ingredient (in each caplet) Diphenhydramine HCl 25 mg

Medication Information

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

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

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

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

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

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

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

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

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

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

Back to search View SPL set listing Open on DailyMed ↗

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