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Banophen by Major Pharmaceuticals

Dosage form: capsule
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 50mg
Labeler: Major Pharmaceuticals
NDC Code: 0904-5307

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 banded capsule)

Diphenhydramine Hydrochloride 50 mg

Purpose

Antihistamine

Use

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itchy throat and nose
  • 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

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions
  • Take every 4-6 hours
  • Do not take more than 6 doses in 24 hours
adults and children 12 years of age and overTake 1 capsule (50 mg)
children under 12 years of age ask a doctor, the proper dosage strength is not available in this package**
**Do not attempt to break capsules. The proper dosage strength and dosing information for children under 12 years of age is available on the 25 mg package.

Other Information
  • Store at room temperature, USP.
  • Do not use if either capsule band or imprinted safety seal under cap is broken or missing
  • Protect from moisture
  • Contains lactose

Inactive Ingredients

D&C Red #28, FD&C Blue #1, FD&C Red #40, Gelatin, Lactose and Starch.

Questions?

Questions or comments? (800) 616-2471

Distributed by

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
BANOPHEN 
diphenhydramine hcl capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-5307
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE50 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 28 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GELATIN 
LACTOSE 
STARCH, CORN 
Product Characteristics
ColorPINK (banded red around the middle) Scoreno score
ShapeCAPSULESize14mm
FlavorImprint CodeCPC;836
Contains    
Packaging
#Item CodePackage Description
1NDC:0904-5307-60100 CAPSULE in 1 BOTTLE
2NDC:0904-5307-801000 CAPSULE in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33611/02/2009
Labeler - Major Pharmaceuticals (191427277)
Registrant - Contract Pharmacal Corp. (968335112)
Establishment
NameAddressID/FEIOperations
Contract Pharmacal Corp.968335112MANUFACTURE(0904-5307)

 
Major Pharmaceuticals

← See all Banophen brands

Medically reviewed on Sep 28, 2017

Further information

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

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