BANOPHEN- diphenhydramine hcl capsule

Banophen by

Drug Labeling and Warnings

Banophen by is a Otc medication manufactured, distributed, or labeled by Bryant Ranch Prepack. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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 over	Take 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 in a dry place at 15° – 30°C (59° – 86°F).
• 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?1-800-231-4670

SPL UNCLASSIFIED SECTION

Distributed by: MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268

(800) 616-2471

www.majorpharmaceuticals.com

HOW SUPPLIED

BANOPHEN

Diphenhydramine Hydrochloride 50mg Capsules

• NDC: 63629-9451-1: 30 CAPSULEs in a BOTTLE
• NDC: 63629-9451-2: 60 CAPSULEs in a BOTTLE

Store in a dry place at 15° – 30°C (59° – 86°F).

Do not use if either capsule band or imprinted safety seal under cap is broken or missing.

Protect from moisture. Contains lactose.

Repackaged/Relabeled by:
Bryant Ranch Prepack
Burbank, CA 91504

PRINCIPAL DISPLAY PANEL

BANOPHEN

Diphenhydramine Hydrochloride 50mg Capsules

INGREDIENTS AND APPEARANCE

BANOPHEN 
diphenhydramine hcl capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63629-9451(NDC:0904-5307)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	50 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	pink	Score	no score
Shape	CAPSULE	Size	14mm
Flavor		Imprint Code	CPC;836
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63629-9451-1	30 in 1 BOTTLE; Type 0: Not a Combination Product	09/26/2022
2	NDC: 63629-9451-2	60 in 1 BOTTLE; Type 0: Not a Combination Product	09/26/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	11/02/2009	01/31/2028

Labeler - Bryant Ranch Prepack (171714327)

Registrant - Bryant Ranch Prepack (171714327)

Establishment
Name	Address	ID/FEI	Business Operations
Bryant Ranch Prepack		171714327	REPACK(63629-9451) , RELABEL(63629-9451)