CHLORPHEN SR- chlorpheniramine maleate tablet, film coated, extended release 
GM Pharmaceuticals, INC

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Chlorphen SR

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

GM Pharmaceuticals, Inc.

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Chlorphen SR TM

Active Ingredient

Chlorpheniramine maleate 12 mg

Purpose

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
  • alcohol, 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

Do not exceed recommended dosage

do not exceed 2 tablets in a 24-hour period.

Adults and children 12 years and over:1 tablet every
12 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

Questions or Comments?

Call 1-888-535-0305

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

PRINCIPAL DISPLAY PANEL

NDC 58809-363-01
Chlorphen SR
Chlorpheniramine
Maleate 12 mg
GM Pharmaceuticals
12 Hour Extended Release Tablets

PRINCIPAL DISPLAY PANEL NDC 58809-363-01 Chlorphen SR Chlorpheniramine Maleate 12 mg GM Pharmaceuticals 12 Hour Extended Release Tablets

PRINCIPAL DISPLAY PANEL NDC 58809-363-01 Chlorphen SR Chlorpheniramine Maleate 12 mg GM Pharmaceuticals 12 Hour Extended Release Tablets

CHLORPHEN SR 
chlorpheniramine maleate tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58809-363
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)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
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
ColorBROWNScoreno score
ShapeROUNDSize7mm
FlavorImprint Code Chlorphen;12
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58809-363-01100 in 1 BOTTLE; Type 0: Not a Combination Product01/04/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA04082906/15/201012/28/2017
Labeler - GM Pharmaceuticals, INC (793000860)

Revised: 11/2019
Document Id: 54fa919a-ecfd-4750-b479-d04a6de9b444
Set id: 299ca4c9-e458-3ef2-e054-00144ff88e88
Version: 3
Effective Time: 20191105
 
GM Pharmaceuticals, INC