BANOPHEN- diphenhydramine hcl capsule 
REMEDYREPACK INC.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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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

  • 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 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

  • 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

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: 70518-1442-0

NDC: 70518-1442-1

NDC: 70518-1442-2

COLOR: pink

SHAPE: CAPSULE

SCORE: No score

SIZE: 14 mm

IMPRINT: CPC;836

PACKAGING: 28 in 1 BLISTER PACK

PACKAGING: 100 in 1 BOX

PACKAGING: 1 in 1 POUCH

ACTIVE INGREDIENT(S):

  • DIPHENHYDRAMINE HYDROCHLORIDE 50mg in 1

INACTIVE INGREDIENT(S):

  • D&C RED NO. 28
  • FD&C BLUE NO. 1
  • FD&C RED NO. 40
  • GELATIN
  • LACTOSE MONOHYDRATE
  • STARCH, CORN

MM2

MM3

BANOPHEN 
diphenhydramine hcl capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70518-1442(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:70518-1442-028 in 1 BLISTER PACK; Type 0: Not a Combination Product09/28/201807/24/2020
2NDC:70518-1442-1100 in 1 BOX08/05/202110/13/2023
2NDC:70518-1442-21 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/28/201810/13/2023
Labeler - REMEDYREPACK INC. (829572556)

Revised: 2/2023
Document Id: f45c701d-aad7-38f6-e053-2a95a90ac712
Set id: 5340773c-688d-45fd-85a2-75f8589f303d
Version: 10
Effective Time: 20230210
 
REMEDYREPACK INC.