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Chlor-Trimeton 12 Hour

Pronunciation

Generic Name: chlorpheniramine maleate
Dosage Form: tablet, extended release

Chlor-Trimeton

Drug Facts

Active ingredient (in each tablet)

Chlorpheniramine maleate 12 mg

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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

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 30 mg
  • store between 20 and 25°C (68 and 77°F)

Inactive ingredients

acacia, calcium phosphate tribasic, calcium sulfate, carnauba wax, corn starch, FD&C yellow No. 6, FD&C yellow No. 6 aluminum lake, lactose monohydrate, magnesium stearate, neutral soap, oleic acid, pharmaceutical ink, povidone, rosin, sucrose, talc, titanium dioxide, white wax, zein

Questions or comments?

Call 1-800-317-2165 between 8:00 AM and 5:00 PM Central Standard Time, Monday through Friday

PRINCIPAL DISPLAY PANEL - 12 mg Carton

Chlor-
Trimeton
®

Allergy

CHLORPHENIRAMINE MALEATE
12 MG/ ANTIHISTAMINE

Allergy Relief:

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

12
HOUR

24 EXTENDED RELEASE TABLETS

Chlor-Trimeton 12 Hour 
chlorpheniramine maleate tablet, extended release
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11523-0728
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Chlorpheniramine Maleate (Chlorpheniramine) Chlorpheniramine Maleate 12 mg
Inactive Ingredients
Ingredient Name Strength
Acacia  
Calcium Sulfate  
Carnauba Wax  
Lactose Monohydrate  
Oleic Acid  
Povidone  
Starch, Corn  
Sucrose  
Talc  
Tribasic Calcium Phosphate  
White Wax  
Zein  
Magnesium Stearate  
Rosin  
Titanium Dioxide  
Product Characteristics
Color ORANGE Score no score
Shape ROUND (double convex round) Size 7mm
Flavor Imprint Code CTM;12
Contains         
Packaging
# Item Code Package Description
1 NDC:11523-0728-1 1 BLISTER PACK (BLISTER PACK) in 1 CARTON
1 24 TABLET, EXTENDED RELEASE (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA007638 01/04/2010
Labeler - Schering Plough HealthCare Products (039137567)
Establishment
Name Address ID/FEI Operations
Schering-Plough Canada 207093332 MANUFACTURE
Revised: 05/2010
 
Schering Plough HealthCare Products



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