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Name:Banophen
Manufacturer:Major Pharmaceuticals
Category:Over-the-counter (OTC) Marketed Drugs


Major 44-190

BANOPHEN - diphenhydramine hydrochloride capsule 
Major Pharmaceuticals

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Major 44-190

Active ingredient (in each banded capsule)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

  • 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

Warnings

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.

Directions

  • 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 1 to 2 capsules 
    children 6 to under 12 years of age 1 capsule 
    children under 6 years of age do not use this product in children under 6 years of age 

Other information

  • store at controlled room temperature 15°-30°C (59°-86°F)

  • protect from moisture

  • see end flap for expiration date and lot number

Inactive ingredients

butylparaben, corn starch, D&C red #28, edible ink, FD&C blue #1, FD&C red #40, gelatin, lactose, magnesium stearate, methylparaben, propylparaben, polysorbate 80, silica gel

Questions or comments?

1-800-426-9391

Principal Display Panel

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

MAJOR®

NDC 0904-2035-59

BANOPHEN™

Complete Allergy Medication

Diphenhydramine HCl 25 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 IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING OR IF RED BAND AROUND CAPSULE IS BROKEN OR MISSING

50844    REV0810J19012

Distributed by

MAJOR PHARMACEUTICALS

31778 Enterprise Drive

Livonia, MI 48150 USA    M-17     Rev. 10/10

Re-order No. 700695

Product Packaging

Product Packaging


BANOPHEN 
diphenhydramine hcl capsule
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-2035
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
BUTYLPARABEN  
D&C RED NO. 28  
FD&C BLUE NO. 1  
D&C RED NO. 28  
GELATIN  
LACTOSE  
MAGNESIUM STEARATE  
METHYLPARABEN  
PROPYLPARABEN  
POLYSORBATE 80  
Product Characteristics
Color PINK Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code 44;107
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0904-2035-59 1 BOTTLE, PLASTIC (1 BOTTLE) in 1 CARTON contains a BOTTLE, PLASTIC
1 100 CAPSULE (100 CAPSULE) in 1 BOTTLE, PLASTIC This package is contained within the CARTON (0904-2035-59)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part336 03/15/1990

Labeler - Major Pharmaceuticals (191427277)

Revised: 04/2011 Major Pharmaceuticals



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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