BANOPHEN- diphenhydramine hcl liquid 
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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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

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

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

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)

Principal Display Panel - 118 mL Bottle Label
BANOPHEN 
diphenhydramine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-1228
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SORBITOL (UNII: 506T60A25R)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
CHERRY (UNII: BUC5I9595W)  
Product Characteristics
Colorred (Bluish-Red) Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-1228-201 in 1 CARTON11/20/200601/31/2021
1NDC:0904-1228-00118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/20/2006
Labeler - Major Pharmaceuticals (191427277)

Revised: 9/2019
Document Id: 93628989-ada6-97a5-e053-2995a90ab7e4
Set id: bafdad7e-20f4-4142-82cc-6d5d175554f4
Version: 5
Effective Time: 20190925
 
Major Pharmaceuticals