CHLORPHENIRAMINE MALEATE - chlorpheniramine maleate tablet 
Cardinal Health

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Active ingredient

In each tablet: Chlorpheniramine maleate 4 mg

Purpose

Antihistamine

Keep Out of Reach of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Uses

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

Warnings

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product

If pregnant or breast-feeding, ask a health professional before use.

Directions

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.

Inactive ingredients

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

Storage

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.]

How Supplied

Chlorpheniramine Maleate Tablets are available as follows:

4 mg - Round, convex, yellow tablets bisected and imprinted with 44 over 194 on one side.

NDC 51079-163-20 - Unit dose blister packages of 100 (10 cards of 10 tablets each).

Manufactured by:

LNK International, Inc.

Hauppauge, NY 11788

Distributed by:

UDL Laboratories, Inc.

Rockford, IL 61103

S-5563 R9

6/10

Principal Display Panel

Chlorpheniramine Maleate

Tablets 4 mg

Antihistamine

10 Tablets

bag label

CHLORPHENIRAMINE MALEATE 
chlorpheniramine maleate tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55154-5456(NDC:51079-163)
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE 4 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE  
STARCH, CORN  
D&C YELLOW NO. 10  
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
Product Characteristics
Color YELLOW Score 2 pieces
Shape ROUND (convex) Size 8mm
Flavor Imprint Code 44;194
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55154-5456-0 10 BLISTER PACK ( BLISTER PACK) in 1 BAG contains a BLISTER PACK
1 1 TABLET ( TABLET) in 1 BLISTER PACK This package is contained within the BAG (55154-5456-0)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 06/06/2011

Labeler - Cardinal Health (188557102)
Establishment
Name Address ID/FEI Operations
Cardinal Health 188557102 REPACK

Revised: 07/2011 Cardinal Health