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 Type HUMAN OTC DRUG Item Code (Source) NDC:37205-117
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 12 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM SULFATE (UNII: WAT0DDB505)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SUCROSE (UNII: C151H8M554)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
GELATIN (UNII: 2G86QN327L)  
HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POVIDONE (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
Color BROWN Score no score
Shape ROUND Size 7mm
Flavor Imprint Code Allergy;12
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:37205-117-62 24 in 1 CARTON
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040829 12/20/2010
Labeler - Cardinal Health, Inc. (097537435)
Registrant - KVK-Tech, Inc. (173360061)
Establishment
Name Address ID/FEI Business Operations
KVK-Tech, Inc. 173360061 MANUFACTURE(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.