Chlorpheniramine Maleate 4 mg

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 over1 tablet every 4 to 6 hours. Do not take more than 6 tablets in 24 hours.
children 6 to under 12 years of age1/2 tablet (break tablet in half) every 4 to 6 hours. Do not exceed 3 whole tablets in 24 hours.
children under 6 years of agedo 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-5456(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
ShapeROUND (convex) Size8mm
FlavorImprint Code 44;194
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:55154-5456-010 BLISTER PACK ( BLISTER PACK) in 1 BAGcontains a BLISTER PACK
11 TABLET ( TABLET) in 1 BLISTER PACKThis package is contained within the BAG (55154-5456-0)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other06/06/2011

Labeler - Cardinal Health (188557102)
Establishment
NameAddressID/FEIOperations
Cardinal Health188557102REPACK

Revised: 07/2011 Cardinal Health