BANOPHEN- diphenhydramine hydrochloride liquid

Banophen by

Drug Labeling and Warnings

Banophen by is a Otc medication manufactured, distributed, or labeled by ATLANTIC BIOLOGICALS CORP.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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, including one applied topically.

Ask a doctor before use if you have

• glaucoma
• 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
• be careful 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.

Directions

• take every 4 to 6 hours
• 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 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, sodium benzoate, sodium citrate, sodium saccharin, sorbitol solution

Questions or comments?

(800) 616-2471

PRINCIPAL DISPLAY PANEL -10 ml Unit Dose Cup

NDC: 17856-5174-1

BANOPHEN™
ORAL SOLUTION

Sugar-Free
Alcohol-Free
Cherry Flavor

(Diphenhydramine HCl, USP)

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

Distributed by
Atlantic Biologicals Corps

Miami, Fl 33179

INGREDIENTS AND APPEARANCE

BANOPHEN 
diphenhydramine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 17856-5174(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 (UNII: 1Q73Q2JULR)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
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)
D&C Red no. 33 (UNII: 9DBA0SBB0L)

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: 17856-5174-1	10 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product	03/10/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	03/10/2017

Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)

Establishment
Name	Address	ID/FEI	Business Operations
ATLANTIC BIOLOGICALS CORP.		047437707	repack(17856-5174) , relabel(17856-5174)