DIPHENHYDRAMINE HYDROCHLORIDE- diphenhydramine hcl capsule

Diphenhydramine hydrochloride by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredient (in each banded 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 of 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 to 6 hours
• do not take more than 6 doses in 24 hours 

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

Other information

• store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
• see end flap for expiration date and lot number
• protect from moisture 

Inactive ingredients

butylparaben, corn starch, D&C red #28, edible ink, FD&C blue #1, FD&C red #40, gelatin, lactose, magnesium stearate, methylparaben, polysorbate 80, propylparaben, silica gel

Questions or comments?

1-800-616-2471

PRINCIPAL DISPLAY PANEL - 25 mg Capsule Blister Pack Carton Label

CommUnityCare Federally Qualified Health Centers

DIPHENHYDRAMINE
25mg/24 Caps

Date:

Name:
Dr.

USE AS DIRECTED.

123456

1/1/01

DIPHENHYDRAMINE 25mg/24 CAPS NDC: 76413-306-24

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

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

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hcl capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76413-306(NDC:0904-2035)
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
BUTYLPARABEN (UNII: 3QPI1U3FV8)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN (UNII: 2G86QN327L)
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)

Product Characteristics
Color	PINK	Score	no score
Shape	CAPSULE	Size	14mm
Flavor		Imprint Code	44;107
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76413-306-24	2 in 1 CARTON	03/15/1990
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	03/15/1990

Labeler - Central Texas Community Health Centers (079674019)

Establishment
Name	Address	ID/FEI	Business Operations
Central Texas Community Health Centers		079674019	REPACK(76413-306) , RELABEL(76413-306)