Trigofen DM

Dosage form: liquid
Ingredients: Chlorpheniramine Maleate 1mg in 1mL, Dextromethorphan Hydrobromide 3mg in 1mL, Phenylephrine Hydrochloride 2mg in 1mL
Labeler: TRIGEN Laboratories, Inc.
NDC Code: 13811-082

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.

Trigofen DM
Drops

Drug Facts

Active Ingredients (in each 1 mL dropperful)Purpose
Chlorpheniramine Maleate 1 mgAntihistamine
Dextromethorphan HBr 3 mgAntitussive
Phenylephrine HCl 2 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 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 the child has
  • a breathing problem such as chronic bronchitis
  • glaucoma
  • a persistent or chronic cough such as occurs with too much phlegm (mucus)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes mellitus

Ask a doctor or pharmacist before use if the 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 4 doses (8 dropperfuls) in a 24 hour period.
Children under 6 years of age:Consult a physician

Other information

Store at 59°-86°F (15°-30°C)

Inactive ingredients

Citric Acid, Methyl Paraben, Orange flavor, Potassium Citrate, Potassium Sorbate, Propyl Paraben, Propylene Glycol, Purified Water, Sorbitol Solution 70%, Sucralose, Vanilla flavor

Questions? Comments?

Call 1-732-721-0070

PRINCIPAL DISPLAY PANEL - 30 mL Carton

NDC 13811-0082-30

Trigofen DM
Drops

Antihistamine • Cough Suppressant
Decongestant
Sugar Free • Alcohol Free • Dye Free

Orange-Vanilla Flavor

Active Ingredients:
Each dropperful (1mL) contains:
Chlorpheniramine Maleate1 mg
Dextromethorphan HBr3 mg
Phenylephrine HCl2 mg

TRIGEN
LABORATORIES

Sayerville, NJ 08872

Net Contents: 1 fl. oz. (30 mL)

TRIGOFEN DM 
chlorpheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13811-082
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Chlorpheniramine Maleate (Chlorpheniramine) Chlorpheniramine Maleate1 mg  in 1 mL
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide3 mg  in 1 mL
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Citric Acid Monohydrate 
Methylparaben 
Potassium Citrate 
Potassium Sorbate 
Propylparaben 
Propylene Glycol 
Water 
Sorbitol 
Sucralose 
Product Characteristics
Color    Score    
ShapeSize
FlavorORANGE, VANILLAImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:13811-082-3030 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/01/201108/30/2014
Labeler - TRIGEN Laboratories, Inc. (830479668)
Establishment
NameAddressID/FEIOperations
TG United Liquid, Inc.830980947manufacture(13811-082)

Revised: 07/2013
 
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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