FDA.reportPublic FDA data

Nighttime Sleep Aid

Manufacturer
TARGET CORPORATION | TIME CAP LABORATORIES, INC | MARKSANS PHARMA LIMITED
Effective date
2023-12-21
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 the relief of occasional sleeplessness ■ reduces time to fall asleep if you have difficulty falling asleep

Dosage and administration

■ take only one dose per day (24 hours) adults & children 12 yrs & over 2 softgels at bedtime if needed or as directed by a doctor children under 12 yrs do not use

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25 mg

Purpose

OTC - PURPOSE SECTION

Nighttime sleep-aid

Uses

INDICATIONS & USAGE SECTION

■ for the relief of occasional sleeplessness
■ reduces time to fall asleep if you have difficulty falling asleep

Warnings

WARNINGS SECTION

Do not use
■ for children under 12 years of age
■ with any other product containing diphenhydramine, even one used on skin.

OTC - DO NOT USE SECTION

Do not use
■ for children under 12 years of age
■ with any other product containing diphenhydramine, even one used on skin.

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

OTC - WHEN USING SECTION

When using this product
■ avoid alcoholic beverages

OTC - STOP USE SECTION

Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

■ take only one dose per day (24 hours)


adults & children 12 yrs & over
2 softgels at bedtime if needed or as directed by a doctor
children under 12 yrsdo not use

Other information

OTHER SAFETY INFORMATION

■ store at 20-25° C (68-77°F)
■ avoid excessive heat above 40°C (104°F)
■ protect from light

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C blue no. 1, FD&C red no. 40, gelatin, polyethylene glycol 400, propylene glycol, purified water, shellac,sorbitol sorbitan solution, titanium dioxide.

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-910-6874

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

613T-Target-Diphenhydramine-24s-IFC613T-Target-Diphenhydramine-24s-IFC613T-Target-Diphenhydramine-48s-IFC613T-Target-Diphenhydramine-48s-IFC

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN2
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD2

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
11673-703-24Nighttime Sleep Aid2 in 1 CARTONCAPSULE, LIQUID FILLED22
11673-703-24Nighttime Sleep Aid12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED122
11673-703-48Nighttime Sleep Aid12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED122
11673-703-48Nighttime Sleep Aid4 in 1 CARTONCAPSULE, LIQUID FILLED42

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11673-703NIGHTTIME SLEEP AID (DIPHENHYRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [TARGET CORPORATION]2Current NDC, 4 package rows20240115_fac83dad-f6fd-3316-e053-6394a90a99aa.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11673-70311673-703-24, 11673-703-48

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
PROPYLENE GLYCOL6DC9Q167V3IACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
SHELLAC46N107B71OIACT
WATER059QF0KO0RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FD&C RED NO. 40WZB9127XOAIACT
GELATIN2G86QN327LIACT
SORBITOL SOLUTION8KW3E207O2IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
SORBITAN6O92ICV9RUIACT

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 AidDIPHENHYRAMINE HYDROCHLORIDETARGET CORPORATIONfac83dad-f6fd-3316-e053-6394a90a99aa2023-12-21WarningsExact identifier
ndc (package): 11673-703-48
ndc (package): 11673-703-24
ndc (product): 11673-703
ndc11 (package): 11673070324
ndc11 (package): 11673070348
spl id: 0be89c6e-baa1-ba2a-e063-6394a90a5721
spl set id: fac83dad-f6fd-3316-e053-6394a90a99aa

Reported adverse events (FAERS/openFDA)#

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