CPM/PSE- chlorpheniramine maleate and pseudoephedrine hydrochloride solution/ drops 
TRIGEN Laboratories, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Drug Facts

Active Ingredients (in each 1 mL dropperful)Purpose
Chlorpheniramine Maleate 0.8 mgAntihistamine
Psuedoephedrine HCl 9 mgNasal Decongestant

Uses

Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other respiratory allergies:

  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes
  • nasal congestion
  • reduces swelling of nasal passages

Warnings

Do not exceed recommended dosage.

Do not use this product in a child who is

  • now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product

Ask a doctor before use if a child has

  • a breathing problem such as chronic bronchitis
  • glaucoma
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes mellitus

Ask a doctor before use if a child is taking sedatives or tranquilizers.

When using this product

  • excitability may occur, especially in children
  • may cause drowsiness
  • sedatives and tranquilizers may increase drowsiness effect

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • new symptoms occur

Keep out of reach of children.

In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

Directions

Do not exceed recommended dosage.

Children 6 to under 12 years of age:2 dropperfuls (2 mL) every 4 to 6 hours, not to exceed 8 dropperfuls in 24 hours or as directed by a doctor
Children under 6 years of age:Consult a doctor

Other information

Store at 59°-86°F (15°-30°F); [see USP Controlled Room Temperature]

Inactive ingredients

Cherry Flavor, Citric Acid, FD&C Red # 40, Glycerin, Methyl Paraben, Potassium Citrate, Potassium Sorbate, Propyl Paraben, Propylene Glycol, Purified Water, Sucralose

Questions? Comments?

Call 888 9 TRIGEN
(888-987-4436)

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

NDC #13811-071-30

CPM/PSE
DROPS

ANTIHISTAMINE • NASAL DECONGESTANT

Sugar Free • Alcohol Free

Active Ingredients:
Each dropperful (1mL) contains:
Chlorpheniramine Maleate0 8 mg
Pseudoephedrine HCl9 mg

Cherry Flavor

TRIGEN
LABORATORIES
Sayreville, NJ 08872

1 FL OZ (30mL)

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton
CPM/PSE 
chlorpheniramine maleate and pseudoephedrine hydrochloride solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13811-071
Route of AdministrationNASALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Chlorpheniramine Maleate (Chlorpheniramine) Chlorpheniramine Maleate0.8 mg  in 1 mL
Pseudoephedrine Hydrochloride (Pseudoephedrine) Pseudoephedrine Hydrochloride9 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Citric Acid Monohydrate 
FD&C Red No. 40 
Glycerin 
Methylparaben 
Potassium Citrate 
Potassium Sorbate 
Propylparaben 
Propylene Glycol 
Water 
Sucralose 
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:13811-071-301 in 1 CARTON
130 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34101/01/2010
Labeler - TRIGEN Laboratories, Inc. (830479668)
Establishment
NameAddressID/FEIBusiness Operations
TG United830980947MANUFACTURE

Revised: 08/2011
 
TRIGEN Laboratories, Inc.