DIPHENHYDRAMINE HYDROCHLORIDE- diphenhydramine hydrochloride tablet, film coated 
Mylan Institutional Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

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

Active ingredient (in each tablet)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

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

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 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 children under 6 years of age

Other information

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

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

Questions?

1-800-848-0462

Serious side effects associated with use of this product 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 of 10 tablets each).

NDC 51079-967-19 - Robot Ready blister packages of 25 (25 cards of 1 tablet each).

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

Manufactured by:
LNK International, Inc.
Hauppauge, NY 11788

Distributed by:
UDL Laboratories, Inc.
Rockford, IL 61103

S-8805 R4
7/10

PRINCIPAL DISPLAY PANEL - 25 mg

NDC 51079-967-20

DIPHENHYDRAMINE
HYDROCHLORIDE
TABLETS
25 mg

Antihistamine

100 Tablets (10 x 10)

Protect from moisture.

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

Manufactured by:
LNK International, Inc.
Hauppauge, NY 11788

S-8806 R2

Packaged and Distributed by:
UDL LABORATORIES, INC.
ROCKFORD, IL 61103

This unit dose package is not child resistant.

For institutional use only.

Keep this and all drugs out of the reach of children.

This container provides light-resistance.

See window for lot number and expiration date.

 Diphenhydramine Hydrochloride Carton
Unit Carton
DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:51079-967
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorPINKScoreno score
ShapeOVAL (capsule shaped) Size11mm
FlavorImprint Code 44;329
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51079-967-20100 in 1 BOX, UNIT-DOSE
1NDC:51079-967-011 in 1 BLISTER PACK
2NDC:51079-967-1925 in 1 BOX, UNIT-DOSE
2NDC:51079-967-171 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/14/201111/30/2012
Labeler - Mylan Institutional Inc. (039615992)

Revised: 7/2010
 
Mylan Institutional Inc.