FDA.reportPublic FDA data

banophen

Manufacturer
A-S Medication Solutions
Effective date
2019-02-01
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:58:25

Label at a glance#

Productbanophen
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure12 sections

Indications and uses

temporarily relieves these symptoms of 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 use only with enclosed dosing cup. Do not use with any other device find right dose on chart below mL = milliliter adults and children 12 years and over 10-20mL (25 mg to 50 mg) children 6 to under 12 years 5-10mL (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 (5 mL) contains: sodium 7 mg TAMPER-EVIDENT: Do not use this product if inner foil seal over the mouth of the bottle is cut, torn, broken or missing store at room temperature 20°-25°C (68°-77°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 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 of 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, including one applied topically.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • glaucoma
  • a sodium restricted diet
  • 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
  • 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
  • do not take more than 6 doses in 24 hours
  • use only with enclosed dosing cup. Do not use with any other device
  • find right dose on chart below
  • mL = milliliter
adults and children 12 years and over10-20mL (25 mg to 50 mg)
children 6 to under 12 years5-10mL (12.5 mg to 25 mg)
children 2 to 5 years of agedo not use unless directed by a doctor
children under 2 years of agedo not use

Other information

STORAGE AND HANDLING SECTION

  • each (5 mL) contains: sodium 7 mg
  • TAMPER-EVIDENT: Do not use this product if inner foil seal over the mouth of the bottle is cut, torn, broken or missing
  • 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, 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

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-2935

NDC: 50090-2935-0 118 mL in a BOTTLE / 1 in a CARTON

Diphenhydramine HCl

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1092424Banophen 12.5 MG in 5 mL Oral SolutionPSN3
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN3
1092424diphenhydramine hydrochloride 2.5 MG/ML Oral Solution [Banophen]SBD3
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD3
1092424Banophen 12.5 MG per 5 ML Oral SolutionSY3
1092424Banophen 2.5 MG/ML Oral SolutionSY3
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY3
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY3
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-2935-02023-01-30C16284748780-1f386c64a-0658-0266-e053-dadaa90a7c1aBanophen™ Allergy

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2935-0banophen1 in 1 CARTONLIQUID13
50090-2935-0banophen118 mL in 1 BOTTLELIQUID1183

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2935BANOPHEN (DIPHENHYDRAMINE HCL) LIQUID [A-S MEDICATION SOLUTIONS]3Legacy NDC, 2 package rows20190202_bbe3f9ed-b3b0-4d05-bcaf-6c810a65773e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2935-0ML - Milliliter50090-2935b474daea-77d7-42d0-9d9c-41c8ea42166612019-05-02
0904-1228-00ML - Milliliter0904-1228119a2b62-49ae-4889-bdd5-72f6b7253d5a12015-01-05
0904-1228-20ML - Milliliter0904-1228e6ecd9ea-596b-49fb-9372-e4b7a497c9ff12013-02-13

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50090-293550090-2935-0
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
NameUNIIKind
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
D&C RED NO. 339DBA0SBB0LIACT
FD&C RED NO. 40WZB9127XOAIACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SORBITOL506T60A25RIACT
GLYCERINPDC6A3C0OXIACT
POLYSORBATE 207T1F30V5YHIACT
CHERRYBUC5I9595WIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0ce14b81-98a5-45d0-a166-7f9eea190c94bbe3f9ed-b3b0-4d05-bcaf-6c810a65773e2019-02-01WarningsExact identifier
spl id: 0ce14b81-98a5-45d0-a166-7f9eea190c94
spl set id: bbe3f9ed-b3b0-4d05-bcaf-6c810a65773e

Reported adverse events (FAERS/openFDA)#

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