Banophen description, usages, side effects, indications, overdosage, supplying and lots more!

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Banophen

Major Pharmaceuticals

Major 44-190


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Diphenhydramine HCl 50 mg

Antihistamine

  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose

  • itchy, watery eyes

  • sneezing 

  • itching of the nose or throat

  • temporarily relieves these symptoms due to the common cold:

  • runny nose

  • sneezing

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

  • a breathing problem such as emphysema or chronic bronchitis

  • glaucoma

  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

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

If pregnant of 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.

  • take every 4 to 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 doctro, 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.

  • store at controlled room temperature, see USP

  • do not use if either capsule band is broken or missing

  • protect from moisture

  • contains lactose

D&C red #28, FD&C blue #1, FD&C red #40, gelatin, lactose, and starch

1-800-616-2471

Principal Display Panel

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

MAJOR®

NDC 0904-5307-60

BANOPHEN™

Complete Allergy Medication

Diphenhydramine HCl 50 mg

ANTIHISTAMINE

For the temporary relief of the sympoms of:

• Upper Respiratory Allergies • Hay Fever

100 CAPSULES

Each Capsul Individually Banded For Your Protection

*Compare to the active

ingredient in BENADRYL®

TAMPER EVIDENT: DO NOT USE IF EITHER CAPSULE BAND OR IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

50844    REV0810J19012

Distributed by

MAJOR PHARMACEUTICALS

31778 Enterprise Drive

Livonia, MI 48150 USA   

M-29     Rev. 05/13

Re-order No. 008240

Banophen

Banophen

Diphenhydramine HCl CAPSULE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0904-5307
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE 50 mg

Inactive Ingredients

Ingredient Name Strength
D&C RED NO. 28
FD&C BLUE NO. 1
GELATIN
LACTOSE
FD&C RED NO. 40
STARCH, CORN

Product Characteristics

Color Size Imprint Code Shape
PINK 15 mm CPC;836 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0904-5307-60 100 in 1 BOTTLE
2 NDC:0904-5307-80 1000 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part336 2009-11-02


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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