BANOPHEN- diphenhydramine hydrochloride liquid
ATLANTIC BIOLOGICALS CORP.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Banophen

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

image description

BANOPHEN
diphenhydramine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:17856-5174(NDC:0904-5174)
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:17856-5174-1	10 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product	03/10/2017

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

Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)

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

Revised: 3/2017

Document Id: 03ac4f17-aac9-44ed-9d91-ed6830fe21c4

Set id: 23e653b4-30f4-4038-82ce-78863c3f3101

Version: 1

Effective Time: 20170310

ATLANTIC BIOLOGICALS CORP.