CHLORPHENIRAMINE MALEATE- chlorpheniramine maleate tablet 
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

ALLERGY RELIEF

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

Active ingredient (in each tablet)

Chlorpheniramine maleate 4 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

Warnings

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

drowsiness may occur
avoid alcoholic beverages
alcohol, sedatives, and tranquilizers may increase drowsiness
use caution 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

(4 Hour)

adults and children 12 years of age and over

1 tablet every 4 to 6 hours.
Do not take more than 6 tablets in 24 hours.

children 6 to under 12 years of age

1/2 tablet (break tablet in half) every 4 to 6 hours.
Do not exceed 3 whole tablets in 24 hours.

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 excessive moisture
use by expiration date on blister package

Inactive ingredients

anhydrous lactose, corn starch, D&C yellow #10 aluminum lake, magnesium stearate, microcrystalline cellulose

Questions or comments?

1-800-848-0462

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

How Supplied:

Chlorpheniramine Maleate Tablets are available as follows:

4 mg - Yellow, round, convex tablets are bisected with 44 over 194 imprinted on one side of the tablet.

NDC 51079-163-20 - Unit dose blister packages of 100 (10 cards of 10 tablets 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-5563 R10
7/11

  

PRINCIPAL DISPLAY PANEL - 4 mg

NDC 51079-163-20

CHLORPHENIRAMINE
MALEATE
TABLETS
4 mg

Antihistamine 100 Tablets (10 x 10)

Protect from excessive moisture.

ALLERGY RELIEF

4 Hour (See Uses section of enclosed leaflet)

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-5562 R13

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.

Chlorpheniramine Maleate Tablets 4 mg Carton
Unit Carton
CHLORPHENIRAMINE MALEATE 
chlorpheniramine maleate tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:51079-163
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE4 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE 
STARCH, CORN 
D&C YELLOW NO. 10 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
Product Characteristics
ColorYELLOWScore2 pieces
ShapeROUNDSize8mm
FlavorImprint Code 44;194
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51079-163-20100 in 1 BOX, UNIT-DOSE
1NDC:51079-163-011 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/07/201104/30/2013
Labeler - Mylan Institutional Inc. (039615992)

Revised: 7/2011
 
Mylan Institutional Inc.