Diphenhydramine Hydrochloride Capsules

Manufacturer
Proficient Rx LP
Effective date
2024-01-01
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:12:59

Label at a glance#

ProductDiphenhydramine Hydrochloride
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure13 sections

Dosage and administration

Adults and children 12 years and over: take 25 to 50 mg (1 to 2 capsule) every 4 to 6 hours, not more than 12 capsules in 24 hours. Children 6 years to 12 years of age: take 12.5 mg** (1 capsule) every 4 to 6 hours, not more than 6 capsules in 24 hours. Children under 6 years of age: do not use **12.5mg dosage strength is not available in this package.  Do not attempt to break capsule

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine Hydrochloride 25 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Use

INDICATIONS & USAGE SECTION

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies and common cold, sneezing, runny nose, itchy, watery eyes, itchy throat and nose.

Warnings:  Do not use

WARNINGS SECTION

• 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

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

Pregnancy/breast-feeding warning

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. 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 25 to 50 mg (1 to 2 capsule) every 4 to 6 hours, not more than 12 capsules in 24 hours.

Children 6 years to 12 years of age: take 12.5 mg** (1 capsule) every 4 to 6 hours, not more than 6 capsules in 24 hours.

Children under 6 years of age: do not use

**12.5mg dosage strength is not available in this package.  Do not attempt to break capsule

Other information

SPL UNCLASSIFIED SECTION

Store at 20º-25ºC (68º-77ºF); excursions permitted to 15º-30ºC (59º-86ºF). [See USP Controlled Room Temperature].  Protect from excessive moisture.

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C Red #28, FD&C Blue #1, FD&C Red #40, Gelatin, Lactose and Starch.

Questions?

OTC - QUESTIONS SECTION

Questions or comments? (800) 616-2471

Distributed by

MAJOR® PHARMACEUTICALS

31778 Enterprise Drive

Livonia, MI  48150 USA

Repackaged by:

Proficient Rx LP

Thousand Oaks, CA 91320

Re-Order No. 301574

PRINCIPAL DISPLAY PANEL DIPHENHYDRAMINE HCL CAPSULES 25MG

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

63187-771-20
63187-771-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-771DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]5Legacy NDC20240123_278e5b4b-9495-4269-87f2-8897a48ff6f0.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-771-20EA - Each63187-7711c2ce5fb-41fc-4f53-aefb-cc0adcae386f12017-10-13
0904-5306-24EA - Each0904-5306b0edee36-ed2f-4648-b6e0-36b1ba93f7e612019-05-02
0904-5306-60EA - Each0904-5306555c059d-810d-4ef2-9c17-83fdd1a60d9012013-02-11
0904-5306-61EA - Each0904-530679119dfd-637d-4b1f-a12c-6fcdcad2133212012-07-24
0904-5306-80EA - Each0904-53060b4a65cc-9c47-45af-bead-889c34a7981412013-02-11

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63187-77163187-771-20, 63187-771-30, 63187-771-60, 63187-771-90
0904-5306

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML · Source PDF

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ec967a1c-83c4-41c0-85ef-3b30751b17b4278e5b4b-9495-4269-87f2-8897a48ff6f02026-05-01WarningsExact identifier
spl set id: 278e5b4b-9495-4269-87f2-8897a48ff6f0
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEMajor Pharmaceuticals04e70311-6412-4a20-84e3-f6e26d5f19ab2026-02-20WarningsExact identifier
ndc (product): 0904-5306

Reported adverse events (FAERS/openFDA)#

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