BANOPHEN- diphenhydramine hcl tablet 
Cardinal Health

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

Active ingredient (in each tablet)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Complete Allergy Medication

*Compare to the active ingredient in Benadryl Allergy Ultratab

Uses

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

 
glaucoma
 
a breathing problem such as emphysema or chronic bronchitis
 
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 or breast-feeding,

ask a health professional before use.

Keep out of reach of children

This Unit Dose package is not child resistant and is intended for Institutional Use Only. 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, or as directed by a doctor
 
do not take more than 6 times in 24 hours

 adults and children 12 years and over

 1 to 2 tablets 

  children 6 to under 12 years

  1 tablet   

  children under 6 years

  do not use

Other information

 
store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
 
protect from moisture

Inactive ingredients

corn starch, D&C red #27 aluminum lake, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide

Distributed by MAJOR PHARMACEUTICALS

31778 Enterprise Drive

Livonia, MI 48150 USA

Questions or comments? (800)616-2471

Repackaged By:

Cardinal Health

Zanesville, OH 43701

L5011069-10216

L5011069-20216

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

BANOPHEN and MAJOR are trademarks owned by their respective owners.

Principal Display Panel

Banophen

Diphenhydramine HCl 25 mg

10 Minitabs

bag label
BANOPHEN 
diphenhydramine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-6888(NDC:0904-5551)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorPINKScoreno score
ShapeOVALSize11mm
FlavorImprint Code 44;329
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55154-6888-010 in 1 BAG03/02/199903/31/2018
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/02/199003/31/2018
Labeler - Cardinal Health (188557102)
Establishment
NameAddressID/FEIBusiness Operations
Cardinal Health188557102REPACK(55154-6888)

Revised: 4/2018
Document Id: 790d8d13-9b53-438f-a5cb-f7c4617f4b6d
Set id: fdab71c4-8e18-4168-a8da-3d682d0851dc
Version: 3
Effective Time: 20180405
 
Cardinal Health