CHLORPHEN-12- chlorpheniramine maleate tablet, film coated, extended release

Chlorphen-12 by

Drug Labeling and Warnings

Chlorphen-12 by is a Otc medication manufactured, distributed, or labeled by KVK-Tech, Inc., Avanthi, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Principal Display Panel - 24 Tablets Carton

New Look. Same Trusted Ingredient. MADE IN USA

NDC: 10702-017-24

Chlorphen-12

Allergy

• Sneezing
• Runny Nose
• Itchy, Watery Eyes
• Itchy Throat

3 in 1
Fast Acting
Long Lasting
Less Drowsy

24 Tablets

Indoor & Outdoor Allergies
12-hour Extended-Release Tablets

Chlorpheniramine Maleate 12 mg/Antihistamine

Principal Display panel - 60 Tablets Container Label

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

Chlorphen-12
Allergy

• Sneezing
• Runny Nose
• Itchy, Watery Eyes
• Itchy Throat

3 in 1
Fast Acting
Long Lasting
Less Drowsy

60 Tablets

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

PRINCIPAL DISPLAY PANEL

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

Chlorphen-12
Allergy

• Sneezing
• Runny Nose
• Itchy, Watery Eyes
• Itchy Throat

3 in 1
Fast Acting
Long Lasting
Less Drowsy

100 Tablets

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

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

INGREDIENTS AND APPEARANCE

CHLORPHEN-12 
chlorpheniramine maleate tablet, film coated, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10702-017
Route of Administration	ORAL

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)
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
Color	orange	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code	Chlorphen;12
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10702-017-06	60 in 1 BOTTLE; Type 0: Not a Combination Product	06/15/2010
2	NDC: 10702-017-24	24 in 1 CARTON; Type 0: Not a Combination Product	06/15/2010
3	NDC: 10702-017-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	06/15/2010
4	NDC: 10702-017-54	50 in 1 CARTON	11/29/2018
4	NDC: 10702-017-04	4 in 1 PACKAGE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA040829	06/15/2010

Labeler - KVK-Tech, Inc. (173360061)

Registrant - Avanthi, Inc. (832316694)

Establishment
Name	Address	ID/FEI	Business Operations
KVK-Tech, Inc.		173360061	manufacture(10702-017)