Label: BANOPHEN- Diphenhydramine Hcl Capsule - DailyMed

Label: BANOPHEN- diphenhydramine hcl capsule

• Label RSS

View Package Photos

• • 

Drug Label Info

Safety

• Report Adverse Events
• FDA Safety Recalls
• Presence in Breast Milk

Related Resources

• Medline Plus
• Clinical Trials
• PubMed
  • All Citations
  • Adverse Effects
  • Therapeutic Use
  • Pharmacology
  • Clinical Trials
• Biochemical Data Summary

More Info For This Drug

• View Labeling Archives
• RxNorm
• Get Label RSS Feed
• View NDC Code(s)NEW!

• Contains inactivated NDC Code(s) NDC Code(s): 50436-3762-1
• Packager: Unit Dose Services
• This is a repackaged label.
• Source NDC Code(s): 0904-5307

• Category: HUMAN OTC DRUG LABEL
• DEA Schedule: None
• Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated November 7, 2017

If you are a consumer or patient please visit this version.

• Download DRUG LABEL INFO: PDF XML
• Official Label (Printer Friendly)

View All SectionsClose All Sections

• 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 over	Take 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® PHARMACEUTICALS17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152

• HOW SUPPLIED

  Product: 50436-3762

  NDC: 50436-3762-1 30 CAPSULE in a BOTTLE

• DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE BANOPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE
• INGREDIENTS AND APPEARANCE

  BANOPHEN  diphenhydramine hcl capsule

  Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50436-3762(NDC:0904-5307) Route of Administration ORAL

  Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg

  Inactive Ingredients Ingredient Name Strength D&C RED NO. 28 (UNII: 767IP0Y5NH)   FD&C BLUE NO. 1 (UNII: H3R47K3TBD)   FD&C RED NO. 40 (UNII: WZB9127XOA)   GELATIN, UNSPECIFIED (UNII: 2G86QN327L)   LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)   STARCH, CORN (UNII: O8232NY3SJ)

  Product Characteristics Color PINK (banded red around the middle) Score no score Shape CAPSULE Size 14mm Flavor Imprint Code CPC;836 Contains

  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50436-3762-1 30 in 1 BOTTLE; Type 0: Not a Combination Product 11/02/2009

  Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part348 11/02/2009

  Labeler - Unit Dose Services (831995316)

  Establishment
  Name	Address	ID/FEI	Business Operations
  Unit Dose Services	831995316	REPACK(50436-3762) , RELABEL(50436-3762)

View All SectionsClose All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!

BANOPHEN- diphenhydramine hcl capsule

Number of versions: 4

Published Date (What is this?)	Version	Files
Nov 27, 2017	7 (current)	download
Jul 18, 2017	5	download
Dec 8, 2016	3	download
Jun 1, 2012	2	download

BANOPHEN- diphenhydramine hcl capsule

RxCUI	RxNorm NAME	RxTTY
1	1020477	diphenhydrAMINE HCl 50 MG Oral Capsule	PSN
2	1020477	diphenhydramine hydrochloride 50 MG Oral Capsule	SCD
3	1020477	diphenhydramine HCl 50 MG Oral Capsule	SY
4	1020479	BANOPHEN 50 MG Oral Capsule	PSN
5	1020479	diphenhydramine hydrochloride 50 MG Oral Capsule [Banophen]	SBD
6	1020479	Banophen 50 MG Oral Capsule	SY

BANOPHEN- diphenhydramine hcl capsule

To receive this label RSS feed

Copy the URL below and paste it into your RSS Reader application.

https://dailymed.nlm.nih.gov/dailymed/labelrss.cfm?setid=0e06dca9-485a-4367-bcfa-07e0cc27c128

To receive all DailyMed Updates for the last seven days

Copy the URL below and paste it into your RSS Reader application.

https://dailymed.nlm.nih.gov/dailymed/rss.cfm

What will I get with the DailyMed RSS feed?

DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed.

DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use. To view updated drug label links, paste the RSS feed address (URL) shown below into a RSS reader, or use a browser which supports RSS feeds, such as Safari for Mac OS X.

How to discontinue the RSS feed

If you no longer wish to have this DailyMed RSS service, simply delete the copied URL from your RSS Reader.

More about getting RSS News & Updates from DailyMed

Why is DailyMed no longer displaying pill images on the Search Results and Drug Info pages?

Due to inconsistencies between the drug labels on DailyMed and the pill images provided by RxImage, we no longer display the RxImage pill images associated with drug labels.

We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels.

BANOPHEN- diphenhydramine hcl capsule

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.

NDC
1	50436-3762-1 (inactivated)

• Home
• News
  • DailyMed Announcements
  • Get RSS News & Updates
• Search
  • Advanced Search
  • Browse Drug Classes
  • Labels Archives
• FDA Resources
• NLM SPL Resources
  • Download Data
    • All Drug Labels
    • All Index Files
    • All Mapping Files
  • SPL Image Guidelines
  • Presentations & Articles
• Application Development Support
  • Resources
    • Web Services
    • Mapping Files
• Help