DIPHENDYDRAMINE HYDROCHLORIDE description, usages, side effects, indications, overdosage, supplying and lots more!

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DIPHENDYDRAMINE HYDROCHLORIDE

NCS HealthCare of KY, Inc dba Vangard Labs

Diphendydramine Hydrochloride Capsules


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

DRUG FACTS

ACTIVE INGREDIENT (IN EACH CAPSULE)

Diphenhydramine Hydrochloride 50 mg

PURPOSE

Antihistamine

USES

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

• with any other products containing diphenhydramine including one applied topically 

Ask a doctor before use if you have

• 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.

When using this product

• 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,

ask a health professional before use.

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 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

• 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

D&C red #28, FD&C Blue #1, FD&C Red #40, gelatin, lactose and starch.

QUESTIONS?

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

DIPHENDYDRAMINE HYDROCHLORIDE

DIPHENDYDRAMINE HYDROCHLORIDE

DIPHENDYDRAMINE HYDROCHLORIDE CAPSULE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0615-7657(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
ANHYDROUS LACTOSE
GELATIN
D&C RED NO. 28
FD&C RED NO. 40
FD&C BLUE NO. 1
STARCH, CORN

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:0615-7657-39 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part336 2009-01-02


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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