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Chlor-Trimeton 12 Hour Prescribing Information

Package insert / product label
Generic name: chlorpheniramine maleate
Dosage form: tablet, extended release
Drug class: Antihistamines

Medically reviewed by Drugs.com. Last updated on Mar 27, 2023.

Drug Facts

Active ingredient (in each tablet)

Chlorpheniramine maleate 12 mg

Purpose

Antihistamine

Indications and Usage for Chlor-Trimeton 12 Hour

  • 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.

Chlor-Trimeton 12 Hour Dosage and Administration

  • 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

Storage and Handling

  • 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 CodeCTM;12
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11523-0728-11 in 1 CARTON
124 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA00763801/04/2010
Labeler - Schering Plough HealthCare Products (039137567)
Establishment
NameAddressID/FEIBusiness Operations
Schering-Plough Canada207093332MANUFACTURE

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