CHLORPHEN-12- chlorpheniramine maleate tablet, film coated, extended release 
KVK-Tech, Inc.

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Chlorphen-12 (Chlorpheniramine Maleate) Extended-Release Tablets, 12 mg

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

OTHER INFORMATION

INACTIVE INGREDIENTS

PURPOSE

Chlorpheniramine maleate 12 mg is used as an antihistamine.

Manufactured by:

KVK-Tech, Inc.
Newtown, PA 18940

logo

Principal Display Panel - 24 Tablets Carton

New Look. Same Trusted Ingredient. MADE IN USA

NDC 10702-017-24

Chlorphen-12

Allergy


3 in 1
Fast Acting
Long Lasting
Less Drowsy


24 Tablets

Indoor & Outdoor Allergies
12-hour Extended-Release Tablets

Chlorpheniramine Maleate 12 mg/Antihistamine

24 tab pic 1

24 tabs pic 2

Principal Display panel - 60 Tablets Container Label

New Look. Same Trusted Ingredient. MADE IN USA
NDC 10702-017-06


Chlorphen-12
Allergy

3 in 1
Fast Acting
Long Lasting
Less Drowsy


60 Tablets

Indoor & Outdoor Allergies
12-hour Extended-Release Tablets
Chlorpheniramine Maleate 12 mg/Antihistamine

container label - 60s

New Look. Same Trusted Ingredient. MADE IN USA
NDC 10702-017-01


Chlorphen-12
Allergy

3 in 1
Fast Acting
Long Lasting
Less Drowsy


100 Tablets

Indoor & Outdoor Allergies
12-hour Extended-Release Tablets
Chlorpheniramine Maleate 12 mg/Antihistamine

container label - 100s

Principal Display Panel - 4 Tablets in a sachet and a carton of 50 sachets

New Look. Same Trusted Ingredient. MADE IN USA
NDC 10702-017-04

NDC 10702-017-54

Chlorphen-12
Allergy

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat

3 in 1
Fast Acting
Long Lasting
Less Drowsy

4 Tablets in a sachet and a carton of 50 sachets

Indoor & Outdoor Allergies
12-hour Extended-Release Tablets
Chlorpheniramine Maleate 12 mg/Antihistamine

50 sachet carton

4 tablets sachet

CHLORPHEN-12 
chlorpheniramine maleate tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10702-017
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE12 mg
Inactive Ingredients
Ingredient NameStrength
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)  
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 2165RE0K14)  
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
ColororangeScoreno score
ShapeROUNDSize7mm
FlavorImprint Code Chlorphen;12
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10702-017-0660 in 1 BOTTLE; Type 0: Not a Combination Product06/15/2010
2NDC:10702-017-2424 in 1 CARTON; Type 0: Not a Combination Product06/15/2010
3NDC:10702-017-01100 in 1 BOTTLE; Type 0: Not a Combination Product06/15/2010
4NDC:10702-017-5450 in 1 CARTON11/29/2018
4NDC:10702-017-044 in 1 PACKAGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA04082906/15/2010
Labeler - KVK-Tech, Inc. (173360061)
Registrant - Avanthi, Inc. (832316694)
Establishment
NameAddressID/FEIBusiness Operations
KVK-Tech, Inc.173360061manufacture(10702-017)

Revised: 12/2018
Document Id: 7d67f785-a25f-1819-e053-2991aa0a11d3
Set id: 84409269-fe9b-469e-9a66-27b1475231a3
Version: 4
Effective Time: 20181219
 
KVK-Tech, Inc.