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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 nosesneezing

WARNINGS SECTION

Do not use

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin

OTC - DO NOT USE SECTION

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

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.
  • Take every 4-6 hours
  • Do not take more than 6 doses in 24 hours

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

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


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Diphenhydramine 50 mg Capsule