HISTAPRIN- diphenhydramine tablet

HISTAPRIN by

Drug Labeling and Warnings

HISTAPRIN by is a Otc medication manufactured, distributed, or labeled by NorMed. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient (in each caplet)

Diphenhydramine Hydrochloride 25mg

PURPOSE

Antihistamine

INDICATIONS & USAGE

Temporarily relieves these symptoms due to the common cold, hay fever, or other upper respiratory allergies:

• runny nose
• sneezing
• itching of the nose or throat
• itchy, watery eyes

WARNINGS

Do not use with any other products containing diphenhydramine, even one used on skin

ASK DOCTOR

Ask a doctor before use if you have

• trouble urinating due to enlarged prostate gland
• glaucoma
• a breathing problem such as emphysema or chronic bronchiti

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

WHEN USING

When using the product

• drowsiness may occur
• avoid alcoholic beverages
• alcohol, sedatives and tranquilizers may increase the drowsiness effect
• use caution when driving a motor vehicle or operating machinery
• excitability may occur, especially in children

PREGNANCY OR BREAST FEEDING

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.

DOSAGE & ADMINISTRATION

Directions

Do not take more than directed

Adults and children 12 years of age and over:

• Take 1 caplet every 4 to 6 hours while symptoms persist

• do not take more than 6 caplets in 24 hours unless directed by a doctor

Children under 12 years of age: not intended for use in children under 12; ask a doctor

INACTIVE INGREDIENT

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PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HISTAPRIN 
diphenhydramine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50332-0132
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
LACTOSE (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	pink	Score	no score
Shape	OVAL	Size	11mm
Flavor		Imprint Code	T061
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50332-0132-4	50 in 1 BOX, UNIT-DOSE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part336	01/01/2009

Labeler - NorMed (069560969)