BANOPHEN- diphenhydramine hcl capsule 
Bryant Ranch Prepack

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0836-Major(100C/1000C)

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

Do not use

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

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

Inactive Ingredients

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

Questions?

Questions or comments?1-800-231-4670

Distributed by: MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268

(800) 616-2471

www.majorpharmaceuticals.com

HOW SUPPLIED

NDC: 63629-9451-1: 30 CAPSULEs in a BOTTLE

NDC: 63629-9451-2: 60 CAPSULEs in a BOTTLE

Label
BANOPHEN 
diphenhydramine hcl capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63629-9451(NDC:0904-5307)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 mg
Inactive Ingredients
Ingredient NameStrength
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 MONOHYDRATE (UNII: EWQ57Q8I5X)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorpinkScoreno score
ShapeCAPSULESize14mm
FlavorImprint Code CPC;836
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63629-9451-130 in 1 BOTTLE; Type 0: Not a Combination Product09/26/2022
2NDC:63629-9451-260 in 1 BOTTLE; Type 0: Not a Combination Product09/26/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01211/02/2009
Labeler - Bryant Ranch Prepack (171714327)
Registrant - Bryant Ranch Prepack (171714327)
Establishment
NameAddressID/FEIBusiness Operations
Bryant Ranch Prepack171714327REPACK(63629-9451) , RELABEL(63629-9451)

Revised: 4/2024
Document Id: 56c1bc1d-b86a-4ca7-9ce6-2b047d9664f7
Set id: d0f4b9f4-e727-4d47-b156-7bcdcb1606da
Version: 105
Effective Time: 20240404
 
Bryant Ranch Prepack