Diphenhydramine HCl (banophen) Drug Information

banophen

Diphenhydramine HCl

DIPHENHYDRAMINE HYDROCHLORIDE

DIPHENHYDRAMINE

CHERRY

ANHYDROUS CITRIC ACID

D&C RED NO. 33

FD&C RED NO. 40

GLYCERIN

POLYSORBATE 20

WATER

SACCHARIN SODIUM

SODIUM BENZOATE

SODIUM CITRATE, UNSPECIFIED FORM

SORBITOL

Bluish-Red

Drug Facts

Active ingredient (in each 5 mL)

Diphenhydramine HCl USP 12.5 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms of hay fever or other upper respiratory allergies

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

Warnings

Do not use

▪to make a child sleepy
▪with any other product containing diphenhydramine, including one applied topically.

Ask a doctor before use if you have

▪glaucoma
▪a sodium restricted diet
▪trouble urinating due to an enlarged prostate gland
▪a breathing problem such as emphysema or chronic bronchitis

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

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 the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

▪take every 4 to 6 hours
▪do not take more than 6 doses in 24 hours
▪use only with enclosed dosing cup. Do not use with any other device
▪find right dose on chart below
▪mL = milliliter

adults and children 12 years and over	10-20mL (25 mg to 50 mg)
children 6 to under 12 years	5-10mL (12.5 mg to 25 mg)
children 2 to 5 years of age	do not use unless directed by a doctor
children under 2 years of age	do not use

Other information

▪each (5 mL) contains: sodium 7 mg
▪ TAMPER-EVIDENT: Do not use this product if inner foil seal over the mouth of the bottle is cut, torn, broken or missing
▪store at room temperature 20°-25°C (68°-77°F)

Inactive ingredients

artificial cherry flavor, citric acid, D&C Red #33, FD&C Red #40, glycerin, polysorbate 20, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol solution

Questions or comments?

(800) 616-2471

Distributed by:
MAJOR ^® PHARMACEUTICALS
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

MAJOR^®

NDC 0904-1228-00
TAMPER-EVIDENT

Banophen™
ALLERGY

Antihistamine
12.5 mg Diphenhydramine HCl USP

ALCOHOL FREE

FOR THE TEMPORARY
RELIEF OF:
Upper Respiratory Allergies
Hay Fever
The Common Cold

Compare to the active ingredient
of Benadryl^® Allergy Liquid*

4 FL. OZ. (118 mL)

bottle label

banophen (Diphenhydramine HCl) liquid