Banophen

Manufacturer: ATLANTIC BIOLOGICALS CORP.
Effective date: 2017-03-10
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: legacy-cache
Hydrated at: 2026-08-02 01:17:45

Label at a glance#

ProductBanophen

Active ingredientdiphenhydramine hydrochloride

Label structure10 sections

Indications and 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

Dosage and administration

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

Storage and handling

each teaspoonful (5 mL) contains: sodium 7 mg store at room temperature 20°-25°C (68°-77°F)

Contacts and useful links#

PhoneLabel contact(800) 616-2471

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each teaspoonful (5 mL))

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl USP 12.5 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not use

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

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

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

When using this product

OTC - WHEN USING SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

each teaspoonful (5 mL) contains: sodium 7 mg
store at room temperature 20°-25°C (68°-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

(800) 616-2471

PRINCIPAL DISPLAY PANEL -10 ml Unit Dose Cup

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-5174-16	ML - Milliliter	0904-5174	64f0a5e7-0bdc-4c50-ab4e-1a4f91cdbee8	1	2013-02-13

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

Banophen
diphenhydramine hydrochloride
Diphenhydramine
Sodium Citrate
Citric Acid Monohydrate
Sorbitol
FD&C Red no. 40
Glycerin
Polysorbate 20
Cherry
Water
Sodium Benzoate
D&C Red no. 33

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
17856-5174	17856-5174-1
0904-5174

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
diphenhydramine hydrochloride	TC2D6JAD40	ACTIB
Sodium Citrate	1Q73Q2JULR	IACT
Citric Acid Monohydrate	2968PHW8QP	IACT
Sorbitol	506T60A25R	IACT
FD&C Red no. 40	WZB9127XOA	IACT
Glycerin	PDC6A3C0OX	IACT
Polysorbate 20	7T1F30V5YH	IACT
Cherry	BUC5I9595W	IACT
Water	059QF0KO0R	IACT
Sodium Benzoate	OJ245FE5EU	IACT
D&C Red no. 33	9DBA0SBB0L	IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
03ac4f17-aac9-44ed-9d91-ed6830fe21c4			23e653b4-30f4-4038-82ce-78863c3f3101	2017-03-10	Warnings	Exact identifier spl id: 03ac4f17-aac9-44ed-9d91-ed6830fe21c4 spl set id: 23e653b4-30f4-4038-82ce-78863c3f3101

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.