Walgreens 613T Diphenhydramine HCl 25mg capsule

Manufacturer: WALGREENS | TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LIMITED
Effective date: 2025-09-04
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-06-01 01:13:11

Label at a glance#

ProductSleep Aid

Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE

Label structure11 sections

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-877-290-4008

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each softgel)

Diphenhydramine HCl 25 mg

OTC - PURPOSE SECTION

Purpose

Nighttime sleep-aid

INDICATIONS & USAGE SECTION

Uses

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

WARNINGS SECTION

Warnings

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 - STOP USE SECTION

When using this product

avoid alcoholic beverages

OTC - WHEN USING 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.

DOSAGE & ADMINISTRATION SECTION

Directions

take only one dose (2 softgels) 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

OTHER SAFETY INFORMATION

Other information

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

INACTIVE INGREDIENT SECTION

Inactive ingredients

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

OTC - QUESTIONS SECTION

Questions or comments? Call 1-877-290-4008

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

WALG_613T 48ct_IFCWALG_613T 24ct_IFC

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1049909	diphenhydrAMINE HCl 25 MG Oral Capsule	PSN	2
1049909	diphenhydramine hydrochloride 25 MG Oral Capsule	SCD	2

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DIPHENHYDRAMINE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0363-6130-24	Sleep Aid	12 in 1 BLISTER PACK	CAPSULE	12	2
0363-6130-24	Sleep Aid	2 in 1 CARTON	CAPSULE	2	2
0363-6130-48	Sleep Aid	4 in 1 CARTON	CAPSULE	4	2
0363-6130-48	Sleep Aid	12 in 1 BLISTER PACK	CAPSULE	12	2

Products#

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

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

Sleep Aid
Diphenhydramine Hydrochloride
FD&C RED NO. 40
SHELLAC
DIPHENHYDRAMINE
FD&C BLUE NO. 1
GELATIN, UNSPECIFIED
WATER
TITANIUM DIOXIDE
PROPYLENE GLYCOL
SORBITAN
SORBITOL SOLUTION
GLYCERIN
POLYETHYLENE GLYCOL 400

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0363-6130	0363-6130-24, 0363-6130-48

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
Name	UNII	Kind
FD&C RED NO. 40	WZB9127XOA	IACT
SHELLAC	46N107B71O	IACT
DIPHENHYDRAMINE HYDROCHLORIDE	TC2D6JAD40	ACTIB
FD&C BLUE NO. 1	H3R47K3TBD	IACT
GELATIN, UNSPECIFIED	2G86QN327L	IACT
WATER	059QF0KO0R	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SORBITAN	6O92ICV9RU	IACT
SORBITOL SOLUTION	8KW3E207O2	IACT
GLYCERIN	PDC6A3C0OX	IACT
POLYETHYLENE GLYCOL 400	B697894SGQ	IACT

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sleep Aid	DIPHENHYDRAMINE HYDROCHLORIDE	WALGREENS	35b78063-e717-2ccb-e063-6394a90a18eb	2025-09-04	Warnings	Exact identifier ndc (package): 0363-6130-48 ndc (package): 0363-6130-24 ndc (product): 0363-6130 ndc11 (package): 00363613048 ndc11 (package): 00363613024 spl id: 3df38296-8eaa-e9d6-e063-6294a90a97c9 spl set id: 35b78063-e717-2ccb-e063-6394a90a18eb

Reported adverse events (FAERS/openFDA)#

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