Diphenhydramine Hydrochloride

Major Pharmaceuticals

Diphenhydramine Hydrochloride Capsules

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient
• Purpose
• Use
• Warnings:  Do not use
• Ask a doctor before use if you have
• When using this product
• Pregnancy/breast-feeding warning
• Keep out of reach of children
• Directions
• Diphenhydramine Hydrochloride Other information
• Inactive ingredients
• Questions?
• PRINCIPAL DISPLAY PANEL DIPHENHYDRAMINE HCL CAPSULES 25MG
• Purpose
• Warnings: Do not use
• Ask a doctor before use if you have
• Ask a doctor or pharmacist before use if you are
• When using this product
• Pregnancy/breast-feeding warning
• Keep out of reach of children
• Directions
• Diphenhydramine Hydrochloride Other information
• Inactive ingredients
• Questions?
• PRINCIPAL DISPLAY PANEL DIPHENHYDRAMINE HCL CAPSULES 50MG

FULL PRESCRIBING INFORMATION

Active ingredient

Diphenhydramine Hydrochloride 25 mg

Purpose

Antihistamine

Use

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

• to make a child sleepy

• with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

• a breathing problem such as emphysema or chronic bronchitis

• glaucoma

• trouble urinating due to an enlarged prostate gland

When using this product

• 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

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

Keep out of reach of children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

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

Diphenhydramine Hydrochloride Other information

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

Inactive ingredients

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

Questions?

Questions or comments? (800) 616-2471

Distributed by

MAJOR® PHARMACEUTICALS

31778 Enterprise Drive

Livonia, MI  48150 USA

Re-Order No. 301574

PRINCIPAL DISPLAY PANEL DIPHENHYDRAMINE HCL CAPSULES 25MG

Diphenhydramine Hydrochloride 50 mg

Purpose

Antihistamine

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

• to make a child sleepy

• with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

• 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

taking tranquilizers or sedative.

When using this product

• 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

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

Keep out of reach of children

Keep out of reach of children. In case of overdose, get medical help or contact Poison Control Center right away.

Directions

Adults and children 12 years and over: take 50 mg (1 capsule) 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 childrent under 12 years of age is available on the 25 mg package.

Diphenhydramine Hydrochloride Other information

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

Inactive ingredients

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

Questions?

Questions or comments? (800) 616-2471

Distributed by

MAJOR® PHARMACEUTICALS

31778 Enterprise Drive

Livonia, MI  48150 USA

Re-Order No. 301575

PRINCIPAL DISPLAY PANEL DIPHENHYDRAMINE HCL CAPSULES 50MG