FDA.reportPublic FDA data

Target Nighttime Sleep-aid Diphenhydramine Hydrochloride 25 mg Tablets

Manufacturer
TARGET CORPORATION | TIME CAP LABORATORIES, INC.
Effective date
2023-12-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:07:13

Label at a glance#

ProductNighttime Sleep Aid
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

■ for relief of occasional sleeplessness

Dosage and administration

Do not take more than directed. See overdose warning 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

Label contents#

Full prescribing information#

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25 mg

Purpose

OTC - PURPOSE SECTION

Nighttime sleep aid

Uses

INDICATIONS & USAGE SECTION

■ for relief of occasional sleeplessness

WARNINGS SECTION

Warnings

Do not use

OTC - DO NOT USE SECTION

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

■ a breathing problem such as emphysema or chronic bronchitis
■ glaucoma
■ trouble urinating due to an enlarged prostrate gland

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

■ avoid alcoholic drinks
■ drowsiness will occur
■ do not drive a motor vehicle or operate machinery

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Do not take more than directed.
See overdose warning

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 25 mg
■ store between 20-25°C (68-77°F). Avoid high humidity. Protect from light

Inactive ingredients

INACTIVE INGREDIENT SECTION

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-910-6874

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

241R-Target-Diphenhydramine-100s-label241R-Target-Diphenhydramine-100s-label241R-Target-Diphenhydramine-100s-IFC241R-Target-Diphenhydramine-100s-IFC

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN2
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11673-496-01Nighttime Sleep Aid100 in 1 BOTTLETABLET1002
11673-496-01Nighttime Sleep Aid1 in 1 CARTONTABLET12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11673-496NIGHTTIME SLEEP AID (DIPHENYDRAMINE HYDROCHLORIDE) TABLET [TARGET CORPORATION]2Current NDC, 2 package rows20240115_fc7ed67f-bac9-f9ed-e053-6294a90ad9a1.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11673-49611673-496-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
SILICON DIOXIDEETJ7Z6XBU4IACT
MAGNESIUM STEARATE70097M6I30IACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
CARNAUBA WAXR12CBM0EIZIACT
FD&C BLUE NO. 1 ALUMINUM LAKEJ9EQA3S2JMIACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
TALC7SEV7J4R1UIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nighttime Sleep AidDIPHENYDRAMINE HYDROCHLORIDETARGET CORPORATIONfc7ed67f-bac9-f9ed-e053-6294a90ad9a12023-12-16WarningsExact identifier
ndc (package): 11673-496-01
ndc (product): 11673-496
ndc11 (package): 11673049601
spl id: 0c9a396d-ccf7-5267-e063-6294a90aa00c
spl set id: fc7ed67f-bac9-f9ed-e053-6294a90ad9a1

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.