Diphenhydramine hydrochloride

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

Active ingredient (in each banded 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 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

Do not use

OTC - DO NOT USE 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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

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 of 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 Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• take every 4 to 6 hours
• do not take more than 6 doses in 24 hours 

adults and children 12  years of age and over	1 to 2 capsules
children 6 to under 12  years of age	1 capsule
children under 6  years of age	do not use this product  in children under 6  years of age

Other information

SPL UNCLASSIFIED SECTION

• store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
• see end flap for expiration date and lot number
• protect from moisture 

Inactive ingredients

INACTIVE INGREDIENT SECTION

butylparaben, corn starch, D&C red #28, edible ink, FD&C blue #1, FD&C red #40, gelatin, lactose, magnesium stearate, methylparaben, polysorbate 80, propylparaben, silica gel

Questions or comments?

OTC - QUESTIONS SECTION

1-800-616-2471

PRINCIPAL DISPLAY PANEL - 25 mg Capsule Blister Pack Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CommUnityCare Federally Qualified Health Centers

DIPHENHYDRAMINE
25mg/24 Caps

Date:

Name:
Dr.

USE AS DIRECTED.

123456

1/1/01

DIPHENHYDRAMINE 25mg/24 CAPS NDC 76413-306-24

Batch: 123456
Lot: 123456
Exp: 1/1/01
MAJOR

Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.

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FDA-Initiated Inactive NDC Indexing#

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Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

• Diphenhydramine hydrochloride
• Diphenhydramine HCl
• DIPHENHYDRAMINE
• BUTYLPARABEN
• D&C RED NO. 28
• FD&C BLUE NO. 1
• GELATIN
• LACTOSE, UNSPECIFIED FORM
• MAGNESIUM STEARATE
• METHYLPARABEN
• PROPYLPARABEN
• POLYSORBATE 80

NDC Codes#

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

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.

Reported adverse events (FAERS/openFDA)#

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