Virdec DM Drops

Dosage form: liquid
Ingredients: PHENYLEPHRINE HYDROCHLORIDE 3.5mg in 1mL, DEXTROMETHORPHAN HYDROBROMIDE 3mg in 1mL, CHLORPHENIRAMINE MALEATE 1mg in 1mL
Labeler: Virtus Pharmaceuticals, LLC
NDC Code: 76439-320

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.

Virdec DM Drops

Drug Facts

Active Ingredient (in each 1mL dropperful)

Phenylephrine HCl 3.5 mg

Chlorpheniramine Maleate 1 mg

Dextromethorphan HBr 3 mg

Purpose

Nasal Decongestant

Antihistamine

Cough Suppressant

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 or pharmacist before use if a child 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:1 dropperful (1 mL) every 4 to 6 hours, not to exceed 6 dropperfuls in 24 hours or as directed by a doctor
Children under 6 years of age:Consult a doctor

Other information

Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [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 813-283-1344

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL – 30mL Carton

NDC 76439-320-30

Virdec DM Drops

Decongestant • Antihistamine • Antitussive

Sugar Free • Alcohol Free • Gluten Free

Active Ingredient:

Each dropperful (1mL) contains:

Phenylephrine HCl……………….3.5 mg

Chlorpheniramine Maleate………1 mg

Dextromethorphan HBr………….3 mg

WARNING:KEEPTHIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN

Grape Flavor

Virtus Pharmceuticals

NET CONTENTS 1 FL OZ (30 mL)

Dropper Enclosed

Tamper evident by foil seal under cap.

Do not use if foil seal is broken or missing.

Supplied with a child resistant cap.

VIRDEC DM DROPS 
virdec dm drops liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76439-320
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE3.5 mg  in 1 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE3 mg  in 1 mL
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
CITRIC ACID MONOHYDRATE 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
METHYLPARABEN 
POTASSIUM SORBATE 
POTASSIUM CITRATE 
PROPYLENE GLYCOL 
WATER 
SUCRALOSE 
Product Characteristics
ColorPURPLEScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:76439-320-301 BOTTLE (BOTTLE) in 1 CARTON
130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/26/2012
Labeler - Virtus Pharmaceuticals, LLC (969483143)
Registrant - Virtus Pharmacueticals, LLC (969483143)
Establishment
NameAddressID/FEIOperations
Axcentria Pharmaceuticals961871501MANUFACTURE

Revised: 02/2012
 
Virtus Pharmaceuticals, LLC

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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