CHLOR-TRIMETON 12 HOUR- chlorpheniramine maleate tablet, extended release 
Bayer HealthCare LLC.

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Chlor-Trimeton

Drug Facts

Active ingredient (in each tablet)

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

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

PRINCIPAL DISPLAY PANEL - 12 mg Carton
CHLOR-TRIMETON 12 HOUR 
chlorpheniramine maleate tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-0728
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
ACACIA (UNII: 5C5403N26O)  
CALCIUM SULFATE (UNII: WAT0DDB505)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
OLEIC ACID (UNII: 2UMI9U37CP)  
POVIDONE (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
SUCROSE (UNII: C151H8M554)  
TALC (UNII: 7SEV7J4R1U)  
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
WHITE WAX (UNII: 7G1J5DA97F)  
ZEIN (UNII: 80N308T1NN)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
ROSIN (UNII: 88S87KL877)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColororangeScoreno score
ShapeROUND (double convex round) Size7mm
FlavorImprint Code CTM;12
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11523-0728-11 in 1 CARTON01/04/201001/04/2012
124 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA00763801/04/201001/04/2012
Labeler - Bayer HealthCare LLC. (112117283)

Revised: 9/2018
Document Id: 7584ccba-5c52-3ea1-e053-2a91aa0ae088
Set id: ba907153-2639-485b-abd8-af239eccd4ed
Version: 3
Effective Time: 20180910
 
Bayer HealthCare LLC.