FDA.reportPublic FDA data

Banophen

Manufacturer
Lake Erie Medical DBA Quality Care Products LLC
Effective date
2021-05-17
Label type
HUMAN OTC DRUG LABEL
Version
5557
Source
legacy-cache
Hydrated at
2026-08-01 22:44:45

Label at a glance#

ProductBanophen
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure15 sections

Dosage and administration

Take every 4-6 hours Do not take more than 6 doses in 24 hours adults and children 12 years of age and over Take 1 capsule (50 mg) children under 12 years of age ask a doctor, the proper dosage strength is not available in this package** **Do not attempt to break capsules. The proper dosage strength and dosing information for children under 12 years of age is available on the 25 mg package.

Label contents#

Full prescribing information#

Active Ingredient (in each banded capsule)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine Hydrochloride 50 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Use

INDICATIONS & USAGE SECTION

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itchy throat and nose
  • Temporarily relieves these symptoms due to the common cold
    • runny nose
    • sneezing

WARNINGS

WARNINGS SECTION

Do not use

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist

OTC - ASK DOCTOR/PHARMACIST SECTION

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

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Take every 4-6 hours
  • Do not take more than 6 doses in 24 hours
adults and children 12 years of age and overTake 1 capsule (50 mg)
children under 12 years of age ask a doctor, the proper dosage strength is not available in this package**
**Do not attempt to break capsules. The proper dosage strength and dosing information for children under 12 years of age is available on the 25 mg package.

Other Information

SPL UNCLASSIFIED SECTION

  • Store at room temperature, USP.
  • Do not use if either capsule band or imprinted safety seal under cap is broken or missing
  • Protect from moisture
  • Contains lactose

Inactive Ingredients

INACTIVE INGREDIENT SECTION

D&C Red #28, FD&C Blue #1, FD&C Red #40, Gelatin, Lactose and Starch.

Questions?

OTC - QUESTIONS SECTION

Questions or comments? (800) 616-2471

Distributed by

SPL UNCLASSIFIED SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-678-30EA - Each55700-678154eb320-bb55-4adb-9039-de8cd455671a12018-10-11
0904-5307-60EA - Each0904-5307fbc100c3-1d2e-4360-bd2f-a92b1e556d3b12013-02-11
0904-5307-80EA - Each0904-5307602b6862-e0e7-4d9b-bcb4-48a7a3eba31612013-02-11

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55700-67855700-678-30
0904-5307

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
D&C RED NO. 28767IP0Y5NHIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
GELATIN2G86QN327LIACT
LACTOSEJ2B2A4N98GIACT
STARCH, CORNO8232NY3SJIACT

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BanophenDIPHENHYDRAMINE HCLMajor Pharmaceuticals7f2b72cc-d4f7-431f-be61-c103cf8c489e2026-02-20WarningsExact identifier
ndc (product): 0904-5307
dfe50755-ea9e-4810-8f0e-4c018bf13c8d8062efc9-656a-4ca7-9d0a-55ecb16adb7f2022-04-21WarningsExact identifier
spl set id: 8062efc9-656a-4ca7-9d0a-55ecb16adb7f

Reported adverse events (FAERS/openFDA)#

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