Diphendydramine Hydrochloride Capsules

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

ACTIVE INGREDIENT (IN EACH CAPSULE)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine Hydrochloride 50 mg

PURPOSE

OTC - PURPOSE SECTION

Antihistamine

USES

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

WARNINGS SECTION

Do not use

SPL UNCLASSIFIED SECTION

• with any other products containing diphenhydramine including one applied topically 

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 if you are taking taking tranquilizers or sedative.

OTC - ASK DOCTOR/PHARMACIST SECTION

When using this product

OTC - WHEN USING SECTION

• marked drowsiness may occur

• avoid alcoholic drinks

• alcohol, sedatives and tranquilizers may increase drowsiness

• use caution 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 Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years and over: take 1 capsule (50mg) every 4 to 6 hours; not more than 6 capsules in 24 hours.

Children under 12 years: ask a doctor, the proper dosage strength is not available in this package

**Do not attempt to break capsules. The proper dosage strength and dosing information for children under 12 years of age is available on the 25mg package.

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

• store at controlled room temperature. USP

• do not use if either capsule band or imprinted safety seal under cap is broken or missing

• protect from excessive moisture

• use by expiration date on package

• contains lactose

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

Adverse drug event call: (800) 616-2471

Distributed by:

Major^® Pharmaceuticals

31778 Enterprise Drive

Livonia, MI 48150 USA M-29

R 12/09

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Related RxNorm Concepts#

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

• DIPHENDYDRAMINE HYDROCHLORIDE
• DIPHENHYDRAMINE HYDROCHLORIDE
• DIPHENHYDRAMINE
• ANHYDROUS LACTOSE
• GELATIN
• D&C RED NO. 28
• FD&C RED NO. 40
• FD&C BLUE NO. 1
• STARCH, CORN

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 6 matching rows.

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.