BANOPHEN- diphenhydramine hcl capsule

Banophen by

Drug Labeling and Warnings

Banophen by is a Otc medication manufactured, distributed, or labeled by Major Pharmaceuticals, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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
  • sneezing
  • itchy, watery eyes
  • 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 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
• see end flap for expiration date and lot number
• protect from moisture 

Inactive ingredients

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

Questions or comments?

1-800-616-2471

Principal Display Panel

MAJOR®

NDC: 0904-2035-59

B A N O P H E N ™
Complete Allergy Medication
Diphenhydramine HCl 25 mg

ANTIHISTAMINE
For the temporary relief of the symptoms of:
Upper Respiratory Allergies Hay Fever

100 CAPSULES
Each Capsule Individually
Banded For Your Protection

*Compare to the
active ingredient in
BENADRYL®

*This product is not manufactured or distributed by
McNeil Consumer Healthcare, owner of the
registered trademark Benadryl®.
50844          REV0512J19012

Distributed by
MAJOR® PHARMACEUTICALS
31778 Enterprise Drive
Livonia, MI 48150 USA    M-17     Rev. 09/12
Re-order No. 700695

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

Major 44-190

INGREDIENTS AND APPEARANCE

BANOPHEN 
diphenhydramine hcl capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-2035
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Inactive Ingredients
Ingredient Name	Strength
BUTYLPARABEN (UNII: 3QPI1U3FV8)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN (UNII: 2G86QN327L)
MAGNESIUM STEARATE (UNII: 70097M6I30)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	PINK	Score	no score
Shape	CAPSULE	Size	14mm
Flavor		Imprint Code	44;107
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-2035-59	1 in 1 CARTON	03/15/1990	09/15/2020
1		100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	03/15/1990	09/15/2020

Labeler - Major Pharmaceuticals (191427277)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(0904-2035)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	MANUFACTURE(0904-2035) , PACK(0904-2035)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(0904-2035)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	PACK(0904-2035)