banophen

Manufacturer: NuCare Pharmaceuticals,Inc.
Effective date: 2017-07-21
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: legacy-cache
Hydrated at: 2026-08-02 01:14:46

Label at a glance#

Productbanophen

Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE

Label structure9 sections

Indications and uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: sneezing itching of the nose or throat runny nose itchy, watery eyes

Dosage and administration

find right dose on chart below use only enclosed dosing cup designed for use with this product. Do not use any other dosing device. take every 4 to 6 hours do not take more than 6 doses in 24 hours Age (yr) Dose children under 2 years do not use children 2 to 5 years do not use unless directed by a doctor children 6 to 11 years 5 to 10 mL (1 to 2 tsp) Attention: use only enclosed dosing cup designed for use with t...

Storage and handling

each teaspoon contains: sodium 15 mg store at 20-25°C (68-77°F)

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-616-2471

Label contents#

Full prescribing information#

Active ingredient (in each 5 mL)*

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 12.5 mg

*5 mL = 1 teaspoon (tsp)

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
sneezing
itching of the nose or throat
runny nose
itchy, watery eyes

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

with any other product containing diphenhydramine, even one used on skin
to make a child sleepy

Ask a doctor before use if the child has

OTC - ASK DOCTOR SECTION

a breathing problem such as chronic bronchitis
glaucoma
a sodium-restricted diet

Ask a doctor or pharmacist before use if the child is

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

marked drowsiness may occur
excitability may occur, especially in children
sedatives and tranquilizers may increase drowsiness

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

find right dose on chart below
use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
take every 4 to 6 hours
do not take more than 6 doses in 24 hours

Age (yr)	Dose
children under 2 years	do not use
children 2 to 5 years	do not use unless directed by a doctor
children 6 to 11 years	5 to 10 mL (1 to 2 tsp)

Attention: use only enclosed dosing cup designed for use with this product. Do not use any other dosing device

Other information

STORAGE AND HANDLING SECTION

each teaspoon contains: sodium 15 mg
store at 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, D&C red #33, FD&C red #40, flavor, glycerin, high fructose corn syrup, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution

Questions or comments?

OTC - QUESTIONS SECTION

1-800-616-2471

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pdp

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-1228-00	ML - Milliliter	0904-1228	119a2b62-49ae-4889-bdd5-72f6b7253d5a	1	2015-01-05
0904-1228-20	ML - Milliliter	0904-1228	e6ecd9ea-596b-49fb-9372-e4b7a497c9ff	1	2013-02-13

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

banophen
Diphenhydramine HCl
ANHYDROUS CITRIC ACID
D&C RED NO. 33
FD&C RED NO. 40
HIGH FRUCTOSE CORN SYRUP
POLOXAMER 407
WATER
SODIUM BENZOATE
SODIUM CHLORIDE
SODIUM CITRATE
SORBITOL
GLYCERIN
DIPHENHYDRAMINE HYDROCHLORIDE
DIPHENHYDRAMINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
68071-3353	68071-3353-4
0904-1228

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
D&C RED NO. 33	9DBA0SBB0L	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
HIGH FRUCTOSE CORN SYRUP	XY6UN3QB6S	IACT
POLOXAMER 407	TUF2IVW3M2	IACT
WATER	059QF0KO0R	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT
SODIUM CITRATE	1Q73Q2JULR	IACT
SORBITOL	506T60A25R	IACT
GLYCERIN	PDC6A3C0OX	IACT
DIPHENHYDRAMINE HYDROCHLORIDE	TC2D6JAD40	ACTIB

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
a58ca613-b328-a463-e053-2a95a90af99f			54dacae4-2f9f-0b31-e054-00144ff88e88	2020-05-13	Warnings	Exact identifier spl set id: 54dacae4-2f9f-0b31-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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