BENADRYL- diphenhydramine hydrochloride capsule, liquid filled

Benadryl by

Drug Labeling and Warnings

Benadryl by is a Otc medication manufactured, distributed, or labeled by Central Texas Community Health Centers. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each capsule)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat
• 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

• a breathing problem such as emphysema or chronic bronchitis
• glaucoma
• 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. (1-800-222-1222)

Directions

• take every 4 to 6 hours
• do not take more than 6 doses in 24 hours

• adults and children 12 years and over: 1 to 2 capsules
• children 6 to under 12 years: 1 capsule
• children under 6 years: do not use this product in children under 6 years of age

Other information

• store between 20-25°C (68-77°F). Avoid high humidity and excessive heat. Protect from light.
• do not use if carton is open or blister unit is broken

Inactive ingredients

gelatin, glycerin, polyethylene glycol, purified water, sorbitol. Capsules are imprinted with edible dye-free ink.

Questions or comments?

call 1-877-717-2824 (toll-free) or 215-273-8755 (collect)

PRINCIPAL DISPLAY PANEL - 25 mg Capsule Blister Pack Carton Label

Austin/Travis Co. Health & Human Services Dept.

Benadryl
25mg/24
Caps

Date:

Name:
Dr.

USE AS DIRECTED.

1/1/01

123456

Benadryl 25mg/24 CAPS NDC: 76413-332-24

Batch: 123456
Lot: 123456
Exp: 1/1/01
Mckneil

Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.

INGREDIENTS AND APPEARANCE

BENADRYL 
diphenhydramine hydrochloride capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76413-332(NDC:50580-228)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
diphenhydramine hydrochloride (UNII: TC2D6JAD40) (diphenhydramine - UNII:8GTS82S83M)	diphenhydramine hydrochloride	25 mg

Inactive Ingredients
Ingredient Name	Strength
gelatin, unspecified (UNII: 2G86QN327L)
glycerin (UNII: PDC6A3C0OX)
polyethylene glycol, unspecified (UNII: 3WJQ0SDW1A)
water (UNII: 059QF0KO0R)
sorbitol (UNII: 506T60A25R)

Product Characteristics
Color	WHITE (Clear)	Score	no score
Shape	OVAL	Size	15mm
Flavor		Imprint Code	BENADRYL
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76413-332-24	2 in 1 CARTON	03/01/2009
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	03/01/2009

Labeler - Central Texas Community Health Centers (079674019)

Establishment
Name	Address	ID/FEI	Business Operations
Central Texas Community Health Centers		079674019	REPACK(76413-332) , RELABEL(76413-332)