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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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

CHLORPHENIRAMINEMALEATETABLETS4 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 AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE4 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
STARCH, CORN (UNII: O8232NY3SJ)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
Product Characteristics
ColorYELLOWScore2 pieces
ShapeROUND (convex) Size8mm
FlavorImprint Code 44;194
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55154-5456-010 in 1 BAG06/06/201104/30/2013
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other06/06/201104/30/2013
Labeler - Cardinal Health (188557102)
Establishment
NameAddressID/FEIBusiness Operations
Cardinal Health188557102REPACK(55154-5456)

Revised: 1/2018
Document Id: ef9cd6f5-0970-44b0-b89b-df230cb4bc04
Set id: 44ae4be1-688c-493a-9795-b7dd269c7b21
Version: 4
Effective Time: 20180122
 
Cardinal Health