CPM/PSE

Dosage form: solution/ drops
Ingredients: Chlorpheniramine Maleate 0.8mg in 1mL, Pseudoephedrine Hydrochloride 9mg in 1mL
Labeler: TRIGEN Laboratories, Inc.
NDC Code: 13811-071

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.

CPM/PSE
DROPS

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)

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 BOTTLE, DROPPER (BOTTLE) 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/FEIOperations
TG United830980947MANUFACTURE

Revised: 08/2011
 
TRIGEN Laboratories, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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