CHLORPHENIRAMINE MALEATE - chlorpheniramine maleate tablet, film coated, extended release 
Cardinal Health, Inc.

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Unknown Title

Chlorpheniramine maleate 12 mg

Antihistamine

USES

temporarily relieves the following symptoms due to hay fever or other upper respiratory allergies:
sneezing
runny nose
itchy, watery eyes
itching of the nose or throat

WARNINGS

Ask a doctor before use if you have
a breathing problem such as emphysema or chronic bronchitis
glaucoma
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
excitability may occur, especially in children
drowsiness may occur
avoid alcoholic beverages
alchohol, sedatives and tranquilizers may increase drowsiness
use caution when driving a motor vehicle or operating machinery
Call your doctor for medical advice about side effects.
You may report side effects to FDA at 1-800-FDA-1088
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

adults and children 12 years and over: 1 tablet every 12 hours. Do not exceed 2 tablets in 24 hours.
children under 12 years of age: ask a doctor

OTHER INFORMATION

each tablet contains: calcium 28 mg
store between 20° to 25°C (68° to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F)
protect from excessive moisture

INACTIVE INGREDIENTS

calcium sulfate, carnauba wax, colloidal silicon dioxide, confectioner’s sugar, D&C yellow No. 10 aluminum lake, FD&C blue No. 2/indigo carmine aluminum lake, FD&C yellow No. 6, gelatin, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, methyl parahydroxybenzoate, microcrystalline cellulose, pharmaceutical ink, polysorbate 80, povidone, propyl parahydroxybenzoate, propylene glycol, sodium benzoate, sodium lauryl sulphate, sucrose, talc, titanium dioxide, triethyl citrate

PURPOSE

Chlorpheniramine maleate 12 mg is used as an antihistamine.

Manufactured by:
KVK-Tech, Inc.
Newtown, PA 18940
f2f01039-figure-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 37205-117-62
Allergy Tablets

Chlorpheniramine maleate 12 mg

f2f01039-figure-02

CHLORPHENIRAMINE MALEATE 
chlorpheniramine maleate tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:37205-117
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE12 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM SULFATE 
CARNAUBA WAX 
SILICON DIOXIDE 
SUCROSE 
D&C YELLOW NO. 10 
FD&C BLUE NO. 2 
GELATIN 
HYDROXYPROPYL CELLULOSE 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A 
METHYLPARABEN 
CELLULOSE, MICROCRYSTALLINE 
POLYSORBATE 80 
POVIDONE 
PROPYLENE GLYCOL 
SODIUM BENZOATE 
SODIUM LAURETH SULFATE 
TITANIUM DIOXIDE 
TRIETHYL CITRATE 
FD&C YELLOW NO. 6 
TALC 
Product Characteristics
ColorBROWNScoreno score
ShapeROUNDSize7mm
FlavorImprint Code Allergy;12
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37205-117-6224 in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA04082912/20/2010
Labeler - Cardinal Health, Inc. (097537435)
Registrant - KVK-Tech, Inc. (173360061)
Establishment
NameAddressID/FEIBusiness Operations
KVK-Tech, Inc.173360061MANUFACTURE(37205-117)

Revised: 8/2012
Document Id: f2f01039-1739-493f-8b6f-3c0e68c6bda3
Set id: cade2f27-fc17-4538-bcdc-67bafd85371d
Version: 1
Effective Time: 20120830
 
Cardinal Health, Inc.