Diphenhydramine Hydrochloride - Walgreen Company

Manufacturer
Walgreen Company
Effective date
2026-09-28
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
daily-update
Hydrated at
2026-09-30 01:02:05

Label at a glance#

ProductDiphenhydramine Hydrochloride
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

 temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:  runny nose  sneezing  itchy, watery eyes  itching of the nose or throat  temporarily relieves these symptoms due to the common cold:  runny nose  sneezing

Dosage and administration

 take every 4 to 6 hours, or as directed by a doctor  do not take more than 6 doses in 24 hours adults and children 12 years of age and over 1 to 2 capsules children 6 to under 12 years of age 1 capsule children under 6 years of age do not use

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each capsule)

Diphenhydramine HCI 25 mg

OTC - PURPOSE SECTION

Purpose

Antihistamine

Uses

INDICATIONS & USAGE SECTION

 temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:  runny nose  sneezing  itchy, watery eyes  itching of the nose or throat
 temporarily relieves these symptoms due to the common cold:  runny nose  sneezing

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not use

 to make a child sleepy

 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

 trouble urinating due to an enlarged prostate gland

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use ifyou are taking sedatives or tranquilizers

OTC - WHEN USING SECTION

When using this product

 marked drowsiness may occur

 avoid alcoholic drinks
 alcohol, sedatives and tranquilizers may increase drowsiness

 use caution when driving a motor vehicle or operating machinery

 excitability may occur, especially in children

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.

OVERDOSAGE SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

 take every 4 to 6 hours, or as directed by a doctor

 do not take more than 6 doses in 24 hours

adults and children 12 years of age and over1 to 2 capsules
children 6 to under 12 years of age1 capsule
children under 6 years of agedo not use

Other information

OTHER SAFETY INFORMATION

 store in a dry place at 15° – 30°C (59° – 86°F)
 protect from moisture

INACTIVE INGREDIENT SECTION

D&C red #28, FD&C blue #1, FD&C red #40, gelatin, lactose and starch

Questions or comments?

OTC - QUESTIONS SECTION

1-800-925-4733

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED
walgreens.com ©2021 Walgreen Co.
PRODUCT OF JAPAN

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING OR IF RED BAND AROUND CAPSULE IS BROKEN OR MISSING

†Our pharmacists recommend the Walgreens brand. We invite you to compare to national brands

††This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Benadryl®

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Walgreens

Compare to the active ingredient in Benadryl® Allergy††

NDC 0363-9835-01

Relieves allergy symptoms

Allergy Relief

Diphenhysramine HCl 25 mg / Antihistamine

Relief of runny nose, sneezing, itchy throat & itchy, watery eyes

100 Capsules

0835-Walgreen0835-Walgreen

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

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-98350363-9835-01, 0363-9835-06, 0363-9835-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42024-12-06full-release2026-06-01 00:41:05

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
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEWalgreen Companybeb34c94-8370-e97d-e053-2995a90a59cc2024-12-06WarningsExact identifier
ndc (package): 0363-9835-01
ndc (package): 0363-9835-06
ndc (package): 0363-9835-02
ndc (product): 0363-9835
ndc11 (package): 00363983506
ndc11 (package): 00363983502
ndc11 (package): 00363983501
spl set id: beb34c94-8370-e97d-e053-2995a90a59cc

Reported adverse events (FAERS/openFDA)#

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