CPM-PSE DM- chlorpheniramine maleate, dextromethorphan hydrobromide and pseudoephedrine hydrochloride liquid 
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.

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Drug Facts

Active Ingredients (in each 1 mL dropperful)Purpose
Chlorpheniramine Maleate 0.8 mgAntihistamine
Dextromethorphan HBr 3 mgCough Suppressant
Pseudoephedrine HCl 9 mgDecongestant

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
  • cough due to minor throat and bronchial irritation
  • 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 emphysema or chronic bronchitis
  • glaucoma
  • a persistent or chronic cough that occurs with too much phlegm (mucus)
  • 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
  • cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. These could be signs of a serious condition.
  • 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°C) [see USP Controlled Room Temperature]

Inactive ingredients

Citric Acid, FD&C Blue #1, FD&C Red #40, Glycerin, Grape flavor, Methyl Paraben, Potassium Citrate, Potassium Sorbate, Propyl Paraben, Propylene Glycol, Purified Water, Sucralose

Question? Comments?

Call 888 9 TRIGEN (888-987-4436)

Manufactured for:
TRIGEN
LABORATORIES
Sayreville, NJ 08872

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label

NDC 13811-072-30

CPM/PSE DM
Drops

  • Antihistamine
  • Cough Suppressant
  • Decongestant

Sugar Free • Alcohol Free

Each dropperful (1 mL) for oral
administration contains:

Chlorpheniramine
Maleate
0.8 mg
Dextromethorphan HBr3 mg
Pseudoephedrine HCl9 mg

Grape Flavor

1 fl oz (30 mL)

Principal Display Panel
CPM-PSE DM 
chlorpheniramine maleate, dextromethorphan hydrobromide, and pseudoephedrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13811-072
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Chlorpheniramine Maleate (Chlorpheniramine) Chlorpheniramine Maleate0.8 mg  in 1 mL
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide3 mg  in 1 mL
Pseudoephedrine Hydrochloride (Pseudoephedrine) Pseudoephedrine Hydrochloride9 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Citric Acid Monohydrate 
FD&C Blue NO. 1 
FD&C Red NO. 40 
Glycerin 
Methylparaben 
Potassium Citrate 
Potassium Sorbate 
Propylparaben 
Propylene Glycol 
Water 
Sorbitol 
Sucralose 
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:13811-072-3030 mL in 1 BOTTLE
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 United Liquids, Inc.963714766MANUFACTURE

Revised: 08/2011
 
TRIGEN Laboratories, Inc.