2834-CVS

Set ID
6e0f7ab7-eb1e-9a19-e053-2991aa0a6d1f
Manufacturer
CVS Pharmacy, Inc.
Effective date
2024-12-02
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:40:55

Key Label Information

Active Ingredients And Purpose

Drug Facts

Active ingredient (in each caplet) Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Uses

Use

for relief of occasional sleeplessness

Warnings

Warnings

Directions And Dosage

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 Label Information

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

Products

NDC Codes

Ingredients

NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
LIGHT MINERAL OILN6K5787QVPIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIACETINXHX3C3X673IACT
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEO7TSZ97GEPIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STEARIC ACID4ELV7Z65APIACT
MAGNESIUM STEARATE70097M6I30IACT
TALC7SEV7J4R1UIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
HYPROMELLOSES3NXW29V3WOIACT

Complete SPL Sections

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each caplet) Diphenhydramine HCl 25 mg

Purpose

OTC - PURPOSE SECTION

Nighttime sleep-aid

Use

INDICATIONS & USAGE SECTION

for relief of occasional sleeplessness

Warnings

WARNINGS SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

■ 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 SAFETY 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 INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

1-800-231-4670

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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XML bytes
29459

Legacy File Index

FolderFileDate
otc28515ff8-379e-5356-e063-6394a90af3f3.xml2024-12-08
otc2834-500G_13254_LBL_CVS-07-18.jpg2020-12-11
otcb61ddd66-9b48-12ae-e053-2995a90a3639.xml2020-12-11
otc2834-365G-label-back.jpg2019-01-24
otc2834-365G-label-front.jpg2019-01-24
otc7ff9962e-2c1b-28f3-e053-2a91aa0ac7f3.xml2019-01-24