FDA.reportPublic FDA data

walgreens-Diphenhydramine HCl Capsules, 50 mg dye free

Manufacturer
WALGREEN COMPANY | Bionpharma Inc. | SOFTGEL HEALTHCARE PRIVATE LIMITED
Effective date
2025-12-01
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:18:42

Label at a glance#

ProductAllergy Relief
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure17 sections

Indications and uses

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

Dosage and administration

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

Storage and handling

■ store at 20°C to 25°C (68°F to 77°F) ■ avoid high humidity and excessive heat above 40°C (104°F). ■ protect from light

Label contents#

Full prescribing information#

Active ingredient (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 50 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

• May cause excitability especially in children.
• May cause marked drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect.

Do not use

OTC - DO NOT USE SECTION

• for children under 12 years of age • with any other product conaining diphenhydramine, even one used on skin.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

■ glaucoma ■ difficulty in urination due to enlargement of the prostate gland

■ a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use

OTC - ASK DOCTOR/PHARMACIST SECTION

if you are taking sedatives or tranquilizers.

When using this product

OTC - WHEN USING SECTION

■ avoid alcoholic beverages ■ be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

OTC - STOP USE SECTION

sleeplessness persists continuosly for more than 2 weeks

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

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

STORAGE AND HANDLING SECTION

■ store at 20°C to 25°C (68°F to 77°F) ■ avoid high humidity and excessive heat above 40°C (104°F).
■ protect from light

Inactive ingredients

INACTIVE INGREDIENT SECTION

gelatin, glycerin, polyethylene glycol 400, polyethylene glycol 600, propylene glycol, purified water, sorbitol sorbitan solution

Questions or comments?

OTC - QUESTIONS SECTION

call toll-free 1-888-235-2466 (Mon - Fri 9AM - 5PM EST)

SPL UNCLASSIFIED SECTION

DO NOT USE IF TAMPER-EVIDENT SEAL UNDER BOTTLE CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

ƚOur pharmacists recommend the Walgreens brand.

We invite you to compare to national brands.

ƚƚThis product is not manufactured or distributed by Kenvue, Inc.,

owner of the registered trademark Benadryl ®Allergy Extra Strength.

DISTRIBUTED BY: WALGREENS CO.

DEERFIELD, IL 60015

100% SATISFACTION GUARANTEED

wlagreens.com

©2024 Walgreen Co, MADE IN INDIA

Mfg. Lic. No.: TN00002123

L0000957

R0125

Lot No.:

Exp. Date:

carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Walgreens

Compare to the active ingredient in

Benadryl® Allergy Extra Strength

EXTRA STRENGTH

Allergy

Relief

DIPHENHYDRAMINE HCl CAPSULES USP,

50 mg/ANTIHISTAMINE

Dye-Free Extra Strength

Sneezing, itchy, watery eyes;

runny nose & itchy throat or nose

100

SOFTGELS**

(** liquid-filled capsules)

cartoncarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN3
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD3
1020477diphenhydramine HCl 50 MG Oral CapsuleSY3

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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-6123-20Allergy Relief1 in 1 CARTONCAPSULE, LIQUID FILLED13
0363-6123-20Allergy Relief100 in 1 BOTTLECAPSULE, LIQUID FILLED1003

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-61230363-6123-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYETHYLENE GLYCOL 600NL4J9F21N9IACT
SORBITAN6O92ICV9RUIACT
GELATIN2G86QN327LIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SORBITOL506T60A25RIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB

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
Allergy ReliefDIPHENHYDRAMINE HCLWALGREEN COMPANY2969ba8f-c477-222a-e063-6394a90af7032025-12-01WarningsExact identifier
ndc (package): 0363-6123-20
ndc (product): 0363-6123
ndc11 (package): 00363612320
spl id: 44e9ea39-930a-30e6-e063-6394a90a6428
spl set id: 2969ba8f-c477-222a-e063-6394a90af703

Reported adverse events (FAERS/openFDA)#

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