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Banophen

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Unit Dose Services

Diphenhydramine Hydrochloride Capsules


FULL PRESCRIBING INFORMATION: CONTENTS*




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.

Warning

Ask a doctor before use if you have glaucoma, a breathing problem such as emphysema or chronic bronchitis, trouble urinating due to an enlarged prostate gland.

Ask a doctor before use if you have

glaucoma, a breathing problem such as emphysema or chronic bronchitis, trouble urinating due to an enlarged prostate gland.

Ask a doctor or pharmacist before use if you are

taking taking tranquilizers or sedative.

When using this product

you may get drowsy; 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. Do not use any other products containing diphenhydramine.

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 25 mg (1 capsule) every 4 to 6 hours; not more than 6 capsules in 24 hours.

Children under 6 years of age: ask a doctor

Banophen Other information

Store at controlled room temperature 59-86 degrees F.

Inactive ingredients

Lactose, starch, gelatin with bisulfites and artificial colors.

Questions?

Adverse drug event call: (800) 616-2471

DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE BANOPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE

Banophen

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.

Ask a doctor before use if you have glucoma, a breathing problem such as emphysema or chronic bronchitis, trouble urinating due to an enlarged prostate gland.

Ask a doctor before use if you have

glaucoma, a breathing problem such as emphysema or chronic bronchitis, 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

you may get drowsy, 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. Do not use any other products containing diphenhydramine.

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.

Banophen Other information

Store at controlled room temperature (59-86 degrees F). Protect from excessive moisture.

Inactive ingredients

Lactose, starch, gelatin with bisulfites and artificial colors

Questions?

Adverse drug event call: (800) 616-2471

Banophen

Diphenhydramine Hydrochloride CAPSULE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:50436-3762(NDC:0904-5307)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE 50 mg

Inactive Ingredients

Ingredient Name Strength
GELATIN
LACTOSE
CROSCARMELLOSE SODIUM
SILICON DIOXIDE
FD&C RED NO. 40
MAGNESIUM STEARATE

Product Characteristics

Color Size Imprint Code Shape
PINK 4 mm cpc;836 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:50436-3762-1 30 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part348 2009-01-02


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Be sure to consult your doctor before taking any medication!
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