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

WARNINGS

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist

before use if you are taking sedatives or tranquilizers

When using this product

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? (800) 616-2471

Distributed by

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

HOW SUPPLIED

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

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

Diphenhydramine HCI 50mg Capsule

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: 1/2024
Document Id: c67bd5cc-41b4-4b6e-bb72-2f21962daba9
Set id: d0f4b9f4-e727-4d47-b156-7bcdcb1606da
Version: 104
Effective Time: 20240125
 
Bryant Ranch Prepack