Banophen

Manufacturer: Major Pharmaceuticals
Effective date: 2019-09-25
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: legacy-cache
Hydrated at: 2026-08-02 00:09:49

Label at a glance#

ProductBanophen

Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE

Label structure11 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 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

Storage and handling

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

Contacts and useful links#

PhonePoison Help1-800-222-1222

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

Do not use

OTC - DO NOT USE SECTION

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

Ask a docter before use if you have

OTC - ASK DOCTOR SECTION

glaucoma
trouble urinating due to an enlarged prostate gland
a sodium-restricted diet
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
use caution 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 (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

each teaspoonful (5 mL) contains: sodium 7 mg
store between 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, saccharin sodium, sodium benzoate, sodium citrate, sorbitol solution

Questions or comments?

OTC - QUESTIONS SECTION

(800) 616-2471

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

Principal Display Panel - 473 mL Bottle Label

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1049906	diphenhydrAMINE (Oral Liquid)	diphenhydramine hydrochloride 2.5 MG/ML Oral Solution	SCD Active
1092424	BANOPHEN (Oral Liquid)	diphenhydramine hydrochloride 2.5 MG/ML Oral Solution [Banophen]	SBD Active

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
diphenhydramine hydrochloride	ACTIVE INGREDIENT	TC2D6JAD40	1
Diphenhydramine	ACTIVE MOIETY	8GTS82S83M	1
Cherry	INACTIVE INGREDIENT	BUC5I9595W	1
Citric Acid Monohydrate	INACTIVE INGREDIENT	2968PHW8QP	1
D&C Red no. 33	INACTIVE INGREDIENT	9DBA0SBB0L	1
FD&C Red no. 40	INACTIVE INGREDIENT	WZB9127XOA	1
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	1
Polysorbate 20	INACTIVE INGREDIENT	7T1F30V5YH	1
Saccharin Sodium Dihydrate	INACTIVE INGREDIENT	SB8ZUX40TY	1
Sodium Benzoate	INACTIVE INGREDIENT	OJ245FE5EU	1
Sodium Citrate	INACTIVE INGREDIENT	1Q73Q2JULR	1
Sorbitol	INACTIVE INGREDIENT	506T60A25R	1
Water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

Banophen
diphenhydramine hydrochloride
SODIUM CITRATE, UNSPECIFIED FORM
SORBITOL
FD&C RED NO. 40
GLYCERIN
POLYSORBATE 20
CHERRY
WATER
SODIUM BENZOATE
SACCHARIN SODIUM
D&C RED NO. 33
ANHYDROUS CITRIC ACID
DIPHENHYDRAMINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0904-5174	0904-5174-16

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
SODIUM CITRATE, UNSPECIFIED FORM	1Q73Q2JULR	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
SACCHARIN SODIUM	SB8ZUX40TY	IACT
D&C RED NO. 33	9DBA0SBB0L	IACT
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
DIPHENHYDRAMINE HYDROCHLORIDE	TC2D6JAD40	ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 6 · 348 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRABURSAL	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
Saccharin Sodium Dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / DENTAL	0.05 %w/v		Exact identifier — unii candidate 34 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	TABLET / ORAL		42 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	ELIXIR / ORAL	5.02 mg/5ml		Exact identifier — unii candidate 35 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	POWDER, FOR SUSPENSION / ORAL		840 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	SUSPENSION / ORAL		45000 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Cherry	CHERRY	BUC5I9595W	TABLET / ORAL	0.45 mg		Exact identifier — unii candidate 2 equally ranked IID candidates
Saccharin Sodium Dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, CHEWABLE / ORAL		84 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	POWDER, FOR SOLUTION / ORAL		315 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Saccharin Sodium Dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	CONCENTRATE / ORAL		6 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	GRANULE / ORAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
FD&C Red no. 40	FD&C RED NO. 40	WZB9127XOA	POWDER, FOR SOLUTION / ORAL	0.33 mg/5ml		Exact identifier — unii candidate 28 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SOLUTION / INTRAVENOUS		396 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	INJECTION / INTRASYNOVIAL	45 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	EMULSION / TOPICAL	7 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	TABLET / ORAL	337.28 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	CONCENTRATE / ORAL	600 mg/1ml		Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C Red no. 40	FD&C RED NO. 40	WZB9127XOA	SUSPENSION/ DROPS / ORAL		1 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SPRAY / NASAL		9 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	SUSPENSION, EXTENDED RELEASE / ORAL		24 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Saccharin Sodium Dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	FILM, SOLUBLE / BUCCAL		2 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	SYSTEM / TOPICAL		6300 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	SYRUP / ORAL	4370 mg/5ml		Exact identifier — unii candidate 44 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	LIQUID / ORAL		114 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / IONTOPHORESIS	0.02 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	LOTION / TOPICAL		3990 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Saccharin Sodium Dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	OINTMENT / DENTAL	NA		Exact identifier — unii candidate 34 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SUSPENSION / OPHTHALMIC	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	CREAM / TOPICAL	36.8 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	SUSPENSION / RECTAL	46.18 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	CAPSULE, LIQUID FILLED / ORAL		185 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SUSPENSION, EXTENDED RELEASE / ORAL		2000 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Saccharin Sodium Dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	GRANULE, FOR SOLUTION / ORAL	5.5 mg/120ml		Exact identifier — unii candidate 34 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	TABLET / ORAL	30 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SOLUTION, CONCENTRATE / IRRIGATION		1 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	CAPSULE / ORAL		1111 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, CHEWABLE / ORAL	7 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	SUSPENSION / ORAL		320 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	AEROSOL, FOAM / TOPICAL	4.95 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / AURICULAR (OTIC)	63.64 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	SUSPENSION / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 28 equally ranked IID candidates
D&C Red no. 33	D&C RED NO. 33	9DBA0SBB0L	CAPSULE, LIQUID FILLED / ORAL	0.01 mg		Exact identifier — unii candidate 14 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	LOTION / TOPICAL	0.85 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
Saccharin Sodium Dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	CAPSULE / ORAL		24 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	DROPS / NASAL	10 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION/ DROPS / OPHTHALMIC		12 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Saccharin Sodium Dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 34 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	AEROSOL, FOAM / TOPICAL	3.7 %w/w		Exact identifier — unii candidate 28 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION, CONCENTRATE / ORAL	200 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	CONCENTRATE / ORAL	5.3 mg/1ml		Exact identifier — unii candidate 88 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	GUM, CHEWING / ORAL		6168 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SOLUTION, CONCENTRATE / INTRAOCULAR		1 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	CLOTH / TOPICAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	INJECTION / INTRAMUSCULAR	1.62 %w/v		Exact identifier — unii candidate 28 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	SYRUP / ORAL		80 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	TABLET, DELAYED RELEASE / ORAL	0.01 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C Red no. 40	FD&C RED NO. 40	WZB9127XOA	ELIXIR / ORAL	12.5 mg/5ml		Exact identifier — unii candidate 28 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / PERIDURAL	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	CREAM / TOPICAL		4 mg	Exact identifier — unii candidate 88 equally ranked IID candidates

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
9362aa10-fbe0-0ce0-e053-2995a90a6186			9f40ea06-bd0b-4db8-91d6-774f65a7f345	2019-09-25	Warnings	Exact identifier spl id: 9362aa10-fbe0-0ce0-e053-2995a90a6186 spl set id: 9f40ea06-bd0b-4db8-91d6-774f65a7f345

Reported adverse events (FAERS/openFDA)#

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

Banophen

Label at a glance#

Indications and uses

Dosage and administration

Storage and handling

Contacts and useful links#

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Active ingredient (in each teaspoonful (5 mL))

Purpose

Uses

Warnings

Do not use

Ask a docter before use if you have

OTC - ASK DOCTOR/PHARMACIST SECTION

When using this product

OTC - PREGNANCY OR BREAST FEEDING SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

Other information

Inactive ingredients

Questions or comments?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

Related RxNorm Concepts#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Products#

NDC Codes#

Ingredients#

Source Document#

Inactive ingredient matches#

openFDA label cross-check#

Reported adverse events (FAERS/openFDA)#