BJs Diphenhydramine Hydrochloride 25 mg Tablets

Manufacturer
BJWC (Berkley & Jensen / BJ's) | TIME CAP LABORATORIES, INC.
Effective date
2025-08-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:12:17

Key Label Information#

Active Ingredients And Purpose

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet) Diphenhydramine HCl 25 mg

OTC - PURPOSE SECTION

Purpose Antihistamine

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Warnings

Directions And Dosage

DOSAGE & ADMINISTRATION SECTION

Directions 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

Other Label Information

INACTIVE INGREDIENT SECTION

Inactive ingredients carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C red #27 aluminum lake, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polysorbate 80, titanium dioxide

OTC - QUESTIONS SECTION

Questions or comments? Call 1-877-290-4008

Label Images#

160R-BJ-Allergy Relief 600ct label
160R-BJ-Allergy Relief 600ct label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN2
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD2

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
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68391-160-33Allergy Relief600 in 1 BOTTLETABLET, FILM COATED6002

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68391-16068391-160-33

Ingredients#

Complete SPL Sections#

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet) Diphenhydramine HCl 25 mg

OTC - PURPOSE SECTION

OTC - PURPOSE SECTION

Purpose Antihistamine

INDICATIONS & USAGE SECTION

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

WARNINGS SECTION

Warnings

DOSAGE & ADMINISTRATION SECTION

DOSAGE & ADMINISTRATION SECTION

Directions 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

OTHER SAFETY INFORMATION

OTHER SAFETY INFORMATION

Other information each tablet contains: calcium 25 mg protect from light store at 25°C (77° F) excursions permitted between 15°-30°C (59°-86°F) use by expiration date on package

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENT SECTION

Inactive ingredients carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C red #27 aluminum lake, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polysorbate 80, titanium dioxide

OTC - QUESTIONS SECTION

OTC - QUESTIONS SECTION

Questions or comments? Call 1-877-290-4008

Source Document#

Source XML