BANOPHEN- diphenhydramine hydrochloride liquid

Banophen by

Drug Labeling and Warnings

Banophen by is a Otc medication manufactured, distributed, or labeled by Major Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredient (in each teaspoonful (5 mL))

Diphenhydramine HCl USP 12.5 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to 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, even one used on skin.

Ask a docter before use if you have

• glaucoma
• trouble urinating due to an enlarged prostate gland
• a sodium-restricted diet
• 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
• find right dose on chart below
• do not take more than 6 doses in 24 hours

• adults and children 12 years and over: 2 - 4 teaspoonsful (25 mg to 50 mg)
• children 6 to under 12 years: 1 - 2 teaspoonsful (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 teaspoonful (5 mL) contains: sodium 7 mg
• store between 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

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

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

NDC: 0904-5174-16

BANOPHEN™
ORAL SOLUTION

Sugar-Free
Alcohol-Free
Cherry Flavor

(Diphenhydramine HCl, USP)

Each teaspoonful (5 mL) contains:
Diphenhydramine
Hydrochloride, USP       12.5 mg

TAMPER-EVIDENT: Do not use this product
if inner foil seal over the mouth of the
bottle is cut, torn, broken or missing.

This Large Size Is
For Dispensing Purpose Only

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

ONE PINT (473 mL)

MAJOR®
PHARMACEUTICALS

INGREDIENTS AND APPEARANCE

BANOPHEN 
diphenhydramine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-5174
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	12.5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
CHERRY (UNII: BUC5I9595W)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

Product Characteristics
Color	pink	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-5174-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/24/2012	10/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	08/24/2012	10/31/2020

Labeler - Major Pharmaceuticals (191427277)