Allergy Relief

Manufacturer
BIONPHARMA INC. | SOFTGEL HEALTHCARE PRIVATE LIMITED
Effective date
2026-02-27
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:47:33

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 containing 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 continuously 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 Centre 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 IMPRINTED WITH “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

†This product is not manufactured or distributed by the owners of Benadryl® Allergy Extra Strength.

Manufactured for:

Bionpharma

Princeton, NJ 08540

Mfg. Lic. No.: TN00002123

L0000864
R0524
2122631

100's count

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

†Compare to the active ingredient in Benadryl® Allergy Extra Strength

NDC 69452-452-20

a+ health TM

dye-free

extra strength

allergy relief

diphenhydramine HCl capsules USP, 50 mg

antihistamine

• sneezing • runny nose
• itchy, watery eyes • 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
69452-452-20Allergy Relief1 in 1 CARTONCAPSULE, LIQUID FILLED13
69452-452-20Allergy Relief100 in 1 BOTTLECAPSULE, LIQUID FILLED1003
69452-452-83Allergy Relief300 in 1 BOTTLECAPSULE, LIQUID FILLED3003

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
69452-45269452-452-20, 69452-452-83

Ingredients#

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

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

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22025-12-01monthly-update2026-06-03 17:45:07

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 HCLBIONPHARMA INC.1f737b76-14b5-618a-e063-6294a90a19c22026-02-27WarningsExact identifier
ndc (package): 69452-452-20
ndc (package): 69452-452-83
ndc (product): 69452-452
ndc11 (package): 69452045220
ndc11 (package): 69452045283
spl id: 4bd1057c-3ae7-5275-e063-6394a90af757
spl set id: 1f737b76-14b5-618a-e063-6294a90a19c2

Reported adverse events (FAERS/openFDA)#

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