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

Purpose:

Antihistamine

INDICATIONS & USAGE

Uses:

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

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 bronchitis

ASK DOCTOR/PHARMACIST

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

WHEN USING

When using this 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. 1-800-222-1222

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: ask a doctor

OTHER SAFETY INFORMATION

Other information:

• each caplet contains calcium 30mg
• caplet enclosed in a sealed packet
• do not use if packet is torn, cut, or open
• store at 59° to 86°F (15°-30°C) in a dry place
• avoid excessive heat and humidity
• protect from light and moisture

INACTIVE INGREDIENT

corn starch, D&C red #27 aluminum lake, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HISTAPRIN 
diphenhydramine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50332-0150
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
STARCH, CORN (UNII: O8232NY3SJ)
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	pink	Score	no score
Shape	OVAL	Size	11mm
Flavor		Imprint Code	44;329
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50332-0150-4	50 in 1 BOX, UNIT-DOSE	01/01/2023
1		1 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M	01/01/2023

Labeler - NorMed (069560969)