Diphenhydramine HCl description, usages, side effects, indications, overdosage, supplying and lots more!

Menu
Search

Diphenhydramine HCl

Cardinal Health

Diphenhydramine Hydrochloride 25 mg


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

Drug Facts

(in each tablet)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control Center right away.This package is intended for institutional use only. Keep this and all drugs out of the reach of children. This unit dose package is not child resistant.

Diphenhydramine HCl Uses

■temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

■runny nose ■itchy, watery eyes

■sneezing ■itching of the nose or throat

■temporarily relieves these symptoms due to the common cold:

■runny nose ■sneezing

Warnings

TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

Do not use ■to make a child sleepy

■with any other product containing diphendydramine, 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

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 tablets

children 6 to under

12 years of age 1 tablet

children under 6 years of age do not use this product in chil-

dren under 6 years of age

Inactive ingredients

Corn Starch, D&C red #27 aluminum lake, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide

Storage

■Store at 20° to 25° C (68° to 77° F). [See USP Controlled Room Temperature.]

■Protect from moisture.

■use by expiration date on blister package

Questions?

1-800-848-0462

■Serious side effects associated with use of this products may be reported to this number.

How Supplied:

Diphenhydramine Hydrochloride Tablets are available as follows:
25 mg - Pink film coated capsule shaped tablet imprinted with 44-329 on one side.

NDC 51079-967-20 - Unit dose blister packages of 100 (10 cards or 10 tablets each).

NDC51079-967-19 - Robot Ready blister packages of 25 (25 cards of 1 tablet each).

Manufactured by:

LNK International, Inc.

Hauppauge, NY 11788

Distributed by:

UDL Laboratories, Inc.

Rockford, IL 61103

S-8805 R4

7/10

Principal Display Panel

Diphenhydramine Hydrochloride Tablets

25 mg

10 Tablets

Diphenhydramine HCl

Diphenhydramine HCl

Diphenhydramine HCl TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55154-5482(NDC:51079-967)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE 25 mg

Inactive Ingredients

Ingredient Name Strength
STARCH, CORN
D&C RED NO. 27
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
MAGNESIUM STEARATE
cellulose, microcrystalline
POLYETHYLENE GLYCOLS
POLYVINYL ALCOHOL
SILICON DIOXIDE
STEARIC ACID
talc
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
PINK 11 mm 44;329 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 1 in 1 BLISTER PACK
2 NDC:55154-5482-0 10 in 1 BAG

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2011-06-03


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
Copyright © 2014. drugs-library.com. All rights reserved. Information on drugs-library.com is provided for educational purposes only and is not to be used for medical advice, diagnosis or treatment.
Support info@drugs-library.com.