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Chlorphen SR

Medically reviewed on June 29, 2018

Dosage form: tablet, film coated, extended release
Ingredients: CHLORPHENIRAMINE MALEATE 12mg
Labeler: GM Pharmaceuticals, INC
NDC Code: 58809-363

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

CHLORPHEN SR 
chlorpheniramine maleate tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58809-363
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, UNSPECIFIED 
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 CodeChlorphen;12
Contains    
Packaging
#Item CodePackage Description
1NDC:58809-363-01100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA04082906/15/2010
Labeler - GM Pharmaceuticals, INC (793000860)

 
GM Pharmaceuticals, INC

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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