BANOPHEN- diphenhydramine hcl capsule 
REMEDYREPACK INC.

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.

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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?

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Distributed by

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

DRUG: Banophen

GENERIC: diphenhydramine hcl

DOSAGE: CAPSULE

ADMINSTRATION: ORAL

NDC: 70518-1289-0

NDC: 70518-1289-1

COLOR: pink

SHAPE: CAPSULE

SCORE: No score

SIZE: 14 mm

IMPRINT: CPC;836

PACKAGING: 30 in 1 BLISTER PACK

PACKAGING: 10 in 1 BOTTLE PLASTIC

ACTIVE INGREDIENT(S):

INACTIVE INGREDIENT(S):

MM1

BANOPHEN 
diphenhydramine hcl capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70518-1289(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 (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:70518-1289-030 in 1 BLISTER PACK; Type 0: Not a Combination Product08/09/2018
2NDC:70518-1289-110 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/26/201906/16/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/09/2018
Labeler - REMEDYREPACK INC. (829572556)

Revised: 9/2022
Document Id: e8a781d1-e992-2cd4-e053-2a95a90adc4e
Set id: 28a98e8d-98c9-4e7c-b978-b567cb280f94
Version: 7
Effective Time: 20220914
 
REMEDYREPACK INC.