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: 71335-0081-1: 15 Capsules in a BOTTLE

NDC: 71335-0081-2: 20 Capsules in a BOTTLE

NDC: 71335-0081-3: 30 Capsules in a BOTTLE

NDC: 71335-0081-4: 10 Capsules in a BOTTLE

NDC: 71335-0081-5: 6 Capsules in a BOTTLE

NDC: 71335-0081-6: 100 Capsules in a BOTTLE

NDC: 71335-0081-7: 90 Capsules in a BOTTLE

NDC: 71335-0081-8: 60 Capsules in a BOTTLE

NDC: 71335-0081-9: 2 Capsules in a BOTTLE

NDC: 71335-0081-0: 12 Capsules in a BOTTLE

Diphenhydramine 50mg Capsule

Label
BANOPHEN 
diphenhydramine hcl capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71335-0081(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:71335-0081-115 in 1 BOTTLE; Type 0: Not a Combination Product05/18/2020
2NDC:71335-0081-220 in 1 BOTTLE; Type 0: Not a Combination Product04/20/2018
3NDC:71335-0081-330 in 1 BOTTLE; Type 0: Not a Combination Product08/15/2018
4NDC:71335-0081-410 in 1 BOTTLE; Type 0: Not a Combination Product09/09/2019
5NDC:71335-0081-56 in 1 BOTTLE; Type 0: Not a Combination Product08/07/2019
6NDC:71335-0081-6100 in 1 BOTTLE; Type 0: Not a Combination Product05/07/2018
7NDC:71335-0081-790 in 1 BOTTLE; Type 0: Not a Combination Product02/09/2022
8NDC:71335-0081-860 in 1 BOTTLE; Type 0: Not a Combination Product02/09/2022
9NDC:71335-0081-92 in 1 BOTTLE; Type 0: Not a Combination Product02/09/2022
10NDC:71335-0081-012 in 1 BOTTLE; Type 0: Not a Combination Product02/09/2022
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(71335-0081) , RELABEL(71335-0081)

Revised: 1/2024
Document Id: 9827dbca-ef8a-4565-b04e-d83384c91ae9
Set id: 20f00537-2c8a-45d1-8e5f-ec276d0a47b6
Version: 9
Effective Time: 20240126
 
Bryant Ranch Prepack