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Banophen by Major Pharmaceuticals

Medically reviewed on November 16, 2017

Dosage form: capsule
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Major Pharmaceuticals
NDC Code: 0904-2035

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.

Major 44-190-Delisted

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

BANOPHEN 
diphenhydramine hcl capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-2035
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
BUTYLPARABEN 
D&C RED NO. 28 
FD&C BLUE NO. 1 
GELATIN 
MAGNESIUM STEARATE 
METHYLPARABEN 
PROPYLPARABEN 
POLYSORBATE 80 
STARCH, CORN 
Product Characteristics
ColorPINKScoreno score
ShapeCAPSULESize14mm
FlavorImprint Code44;107
Contains    
Packaging
#Item CodePackage Description
1NDC:0904-2035-591 BOTTLE, PLASTIC in 1 CARTON
1100 CAPSULE in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34103/15/199009/15/2020
Labeler - Major Pharmaceuticals (191427277)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(0904-2035)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088MANUFACTURE(0904-2035), PACK(0904-2035)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(0904-2035)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(0904-2035)

 
Major Pharmaceuticals

See Also

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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