Skip to Content

← See all banophen brands

banophen by Major Pharmaceuticals

Dosage form: liquid
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 12.5mg in 5mL
Labeler: Major Pharmaceuticals
NDC Code: 0904-1228

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.

Banophen™ Allergy

Drug Facts

Active ingredient (in each 5 mL)

Diphenhydramine HCl USP 12.5 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms of hay fever or other upper respiratory allergies

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat

Warnings

Do not use
  • to make a child sleepy
  • with any other product containing diphenhydramine, including one applied topically.

Ask a doctor before use if you have
  • glaucoma
  • a sodium restricted diet
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

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
  • use caution when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

If pregnant or breast-feeding, ask a health professional before use.

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions
  • take every 4 to 6 hours
  • do not take more than 6 doses in 24 hours
  • use only with enclosed dosing cup. Do not use with any other device
  • find right dose on chart below
  • mL = milliliter
adults and children 12 years and over10-20mL (25 mg to 50 mg)
children 6 to under 12 years5-10mL (12.5 mg to 25 mg)
children 2 to 5 years of agedo not use unless directed by a doctor
children under 2 years of agedo not use

Other information
  • each (5 mL) contains: sodium 7 mg
  • TAMPER-EVIDENT: Do not use this product if inner foil seal over the mouth of the bottle is cut, torn, broken or missing
  • store at room temperature 20°-25°C (68°-77°F)

Inactive ingredients

artificial cherry flavor, citric acid, D&C Red #33, FD&C Red #40, glycerin, polysorbate 20, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol solution

Questions or comments?

(800) 616-2471

Distributed by:
MAJOR® PHARMACEUTICALS
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

MAJOR®
NDC 0904-1228-00
TAMPER-EVIDENT

Banophen™
ALLERGY

Antihistamine
12.5 mg Diphenhydramine HCl USP

ALCOHOL FREE

FOR THE TEMPORARY
RELIEF OF:
Upper Respiratory Allergies
Hay Fever
The Common Cold

Compare to the active ingredient
of Benadryl® Allergy Liquid*

4 FL. OZ. (118 mL)

BANOPHEN 
diphenhydramine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-1228
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
D&C RED NO. 33 
FD&C RED NO. 40 
WATER 
SODIUM BENZOATE 
Saccharin Sodium 
SODIUM CITRATE, UNSPECIFIED FORM 
SORBITOL 
GLYCERIN 
POLYSORBATE 20 
CHERRY 
Product Characteristics
ColorRED (Bluish-Red) Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0904-1228-201 BOTTLE in 1 CARTON
1NDC:0904-1228-00118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/20/2006
Labeler - Major Pharmaceuticals (191427277)
Registrant - Bio-Pharm, Inc. (801652546)
Establishment
NameAddressID/FEIOperations
Bio-Pharm, Inc.801652546MANUFACTURE(0904-1228), ANALYSIS(0904-1228), PACK(0904-1228), LABEL(0904-1228)

 
Major Pharmaceuticals

Medically reviewed on Oct 26, 2017

See Also

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide