banophen - DailyMed Details

banophen

SPL v7

SPL

SPL Set ID 0e06dca9-485a-4367-bcfa-07e0cc27c128

Route

oral

Published

Effective Date 2017-11-07

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

diphenhydramine (50 mg)

Inactive Ingredients

d&c red no. 28 fd&c blue no. 1 fd&c red no. 40 gelatin, unspecified lactose, unspecified form starch, corn

Identifiers & Packaging

Pill Appearance

Imprint: CPC;836 Shape: capsule Color: pink Size: 14 mm Score: 1

Marketing Status

otc monograph not final active Since 2009-11-02

Purpose

Antihistamine

How Supplied

Product: 50436-3762 NDC: 50436-3762-1 30 CAPSULE in a BOTTLE

Description

Diphenhydramine Hydrochloride 50 mg

Medication Information

Warnings

Do not use

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

Purpose

Antihistamine

Directions

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.

Other Information

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

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

How Supplied

Product: 50436-3762

NDC: 50436-3762-1 30 CAPSULE in a BOTTLE

Description

Diphenhydramine Hydrochloride 50 mg

Questions?

Questions or comments? (800) 616-2471

Use

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

Distributed By

MAJOR® PHARMACEUTICALS

17177 N Laurel Park Drive, Suite 233,

Livonia, MI 48152

When Using This Product

•
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

Ask A Doctor Or Pharmacist

before use if you are taking sedatives or tranquilizers

If Pregnant Or Breast Feeding

ask a health professional before use.

Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have

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

Active Ingredient (in Each Banded Capsule)

Diphenhydramine Hydrochloride 50 mg

Diphenhydramine Hydrochloride Capsule Banophen (diphenhydramine Hydrochloride) Capsule

Structured Label Content

Warnings (WARNINGS)

Do not use

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

Purpose

Antihistamine

Directions

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.

Other Information

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

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

How Supplied (HOW SUPPLIED)

Product: 50436-3762

NDC: 50436-3762-1 30 CAPSULE in a BOTTLE

Questions?

Questions or comments? (800) 616-2471

Use

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

Distributed By (Distributed by)

MAJOR® PHARMACEUTICALS

17177 N Laurel Park Drive, Suite 233,

Livonia, MI 48152

When Using This Product (When using this product)

•
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

Ask A Doctor Or Pharmacist (Ask a doctor or pharmacist)

before use if you are taking sedatives or tranquilizers

If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

ask a health professional before use.

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

In case of overdose, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

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

Active Ingredient (in Each Banded Capsule) (Active Ingredient (in each banded capsule))

Diphenhydramine Hydrochloride 50 mg

Diphenhydramine Hydrochloride Capsule Banophen (diphenhydramine Hydrochloride) Capsule (DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE BANOPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE)

Advanced Ingredient Data

[{"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "50", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "D&C RED NO. 28", "unii": "767IP0Y5NH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN, UNSPECIFIED", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LACTOSE, UNSPECIFIED FORM", "unii": "J2B2A4N98G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "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", "Purpose": "Antihistamine", "WARNINGS": "Do not use • to make a child sleepy • with any other product containing diphenhydramine, even one used on skin", "Directions": "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.", "Questions?": "Questions or comments? (800) 616-2471", "HOW SUPPLIED": "Product: 50436-3762 NDC: 50436-3762-1 30 CAPSULE in a BOTTLE", "Distributed by": "MAJOR® PHARMACEUTICALS 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152", "Other Information": "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": "D&C Red #28, FD&C Blue #1, FD&C Red #40, Gelatin, Lactose and Starch.", "When using this product": "• 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", "Ask a doctor or pharmacist": "before use if you are taking sedatives or tranquilizers", "If pregnant or breast-feeding": "ask a health professional before use.", "KEEP OUT OF REACH OF CHILDREN": "In case of overdose, get medical help or contact a Poison Control Center right away.", "Ask a doctor before use if you have": "• glaucoma • a breathing problem such as emphysema or chronic bronchitis • trouble urinating due to an enlarged prostate gland", "Active Ingredient (in each banded capsule)": "Diphenhydramine Hydrochloride 50 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:26.694689 · Updated: 2026-03-14T22:54:55.117494