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

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

Distributed by: MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268

(800) 616-2471

www.majorpharmaceuticals.com

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

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

Diphenhydramine 50 mg Capsule

BANOPHEN
diphenhydramine hcl capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71335-0081(NDC:0904-5307)
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71335-0081-1	15 in 1 BOTTLE; Type 0: Not a Combination Product	05/18/2020
2	NDC:71335-0081-2	20 in 1 BOTTLE; Type 0: Not a Combination Product	04/20/2018
3	NDC:71335-0081-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	08/15/2018
4	NDC:71335-0081-4	10 in 1 BOTTLE; Type 0: Not a Combination Product	09/09/2019
5	NDC:71335-0081-5	6 in 1 BOTTLE; Type 0: Not a Combination Product	08/07/2019
6	NDC:71335-0081-6	100 in 1 BOTTLE; Type 0: Not a Combination Product	05/07/2018
7	NDC:71335-0081-7	90 in 1 BOTTLE; Type 0: Not a Combination Product	02/09/2022
8	NDC:71335-0081-8	60 in 1 BOTTLE; Type 0: Not a Combination Product	02/09/2022
9	NDC:71335-0081-9	2 in 1 BOTTLE; Type 0: Not a Combination Product	02/09/2022
10	NDC:71335-0081-0	12 in 1 BOTTLE; Type 0: Not a Combination Product	02/09/2022

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

Labeler - Bryant Ranch Prepack (171714327)

Registrant - Bryant Ranch Prepack (171714327)

Name	Address	ID/FEI	Business Operations
Establishment
Bryant Ranch Prepack		171714327	REPACK(71335-0081) , RELABEL(71335-0081)

0836-Major(100C/1000C)