Diphenhydramine HCl 25 mg tablet, A+ Health, allergy relief

Manufacturer
BIONPHARMA INC. | OrBion Pharmaceuticals Private Limited | JOHNSON & SMITH COMPANY
Effective date
2026-10-05
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
daily-update
Hydrated at
2026-10-07 01:01:55

Label at a glance#

ProductAllergy Relief
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure15 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

■ take every 4 to 6 hours, or as directed by a doctor ■ do not take more than 6 times in 24 hours adults and children 12 years and over 1 to 2 tablets children 6 to under 12 years 1 tablet children under 6 years do not use

Storage and handling

■ each tablet contains: calcium 18 mg ■ store between 20-25°C (68-77°F). Protect from light and excessive humidity. Exposure to excessive humidity and/or light may cause the color of the tablets to fade.

Label contents#

Full prescribing information#

Active ingredient (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25 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

Do not use■ to make a child sleepy ■ with any other product containing
diphenhydramine, even one used on skin

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

■ a breathing problem such as emphysema or chronic bronchitis ■ glaucoma
■ trouble urinating due to an enlarged 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

■ marked drowsiness may occur ■ avoid alcoholic drinks ■ alcohol, sedatives, and tranquilizers may increase drowsiness ■ be careful
when driving a motor vehicle or operating machinery ■ excitability may occur, especially in children

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. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

■ take every 4 to 6 hours, or as directed by a doctor ■ do not take more than 6 times in 24 hours

adults and children 12 years and over1 to 2 tablets
children 6 to under 12 years1 tablet
children under 6 yearsdo not use

Other information

STORAGE AND HANDLING SECTION

■ each tablet contains: calcium 18 mg ■ store between 20-25°C (68-77°F).

Protect from light and excessive humidity. Exposure to excessive humidity and/or light may cause the color of the tablets to fade.

Inactive ingredients

INACTIVE INGREDIENT SECTION

carnauba wax, croscarmellose sodium, D&C red no.27, dibasic calcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, 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 Tablets

DO NOT USE IF TAMPER-EVIDENT SEAL UNDER BOTTLE CAP IMPRINTED
WITH“SEALED for YOUR PROTECTION” IS BROKEN OR MISSING.

Manufactured for:
BIONPHARMA INC.
Princeton, NJ 08540

MADE IN INDIA

600's count

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

†Compare to the active ingredient in
Benadryl® Allergy Tablets

NDC 69452-444-31

a+ health TM
diphenhydramine HCl
tablets, 25 mg
antihistamine
allergy relief
• sneezing
• runny nose
• itchy, watery eyes
• itchy throat or nose

600 tablets

600ct-bottle600ct-bottle

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 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69452-44469452-444-31

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22026-08-16daily-update2026-08-19 00:01:58
12025-06-23full-release2026-06-01 01:03:42

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.23750ea1-18a4-bfa7-e063-6394a90afd092026-08-16WarningsExact identifier
ndc (package): 69452-444-31
ndc (product): 69452-444
ndc11 (package): 69452044431
spl set id: 23750ea1-18a4-bfa7-e063-6394a90afd09

Reported adverse events (FAERS/openFDA)#

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