Diphenhydramine HCl 50 mg tablet, A+ Health, allergy relief dye free

Manufacturer
BIONPHARMA INC. | OrBion Pharmaceuticals Private Limited | JOHNSON & SMITH COMPANY
Effective date
2026-06-22
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
monthly-update
Hydrated at
2026-07-17 21:35:12

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 ■ itchy, watery eyes ■ itching of the nose or throat

Dosage and administration

adults and children 12 years and over ■ take 1 tablet every 4 to 6 hours, or as directed by the doctor ■ do not take more than 6 tablets in 24 hours children under 12 years do not use

Storage and handling

■ each tablet contains: calcium 35 mg ■ store between 20-25°C (68-77°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 ■ itchy, watery eyes ■ itching of the nose or throat

Warnings

WARNINGS SECTION

■ May cause excitability especially in children.

■ May cause 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 ■ a breathing problem such as emphysema or chronic bronchitis
■ difficulty in urination due to enlargement of the prostate gland

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 drinks ■ be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

OTC - STOP USE SECTION

sleeplessness persisits 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 tablet every 4 to 6 hours, or as directed by the doctor

■ do not take more than 6 tablets in 24 hours

children under 12 yearsdo not use

Other information

STORAGE AND HANDLING SECTION

■ each tablet contains: calcium 35 mg■ store between 20-25°C (68-77°F). Protect from light.

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, dibasic calcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

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

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Manufactured for:

BIONPHARMA INC.
Princeton, NJ 08540

MADE IN INDIA

Code: KR/DRUGS/KTK/25/610/2013

L0001284

R0426

150''s count

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

a+ health TM

extra strength
allergy relief

diphenhydramine HCl tablets,50 mg

antihistamine

dye

free

150 tablets

• sneezing • runny nose
• itchy, watery eyes • itching of the nose or throat

cartoncarton

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 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69452-44569452-445-77, 69452-445-24

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
32026-01-12full-release2026-06-01 01:32:30
22025-12-08monthly-update2026-06-03 17:45:31

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.3c1953a1-32e9-6c81-e063-6294a90a9fa22026-06-22WarningsExact identifier
ndc (package): 69452-445-77
ndc (package): 69452-445-24
ndc (product): 69452-445
ndc11 (package): 69452044577
ndc11 (package): 69452044524
spl id: 54dcfbdc-23e6-c4e3-e063-6294a90ad945
spl set id: 3c1953a1-32e9-6c81-e063-6294a90a9fa2

Reported adverse events (FAERS/openFDA)#

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