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Viravan PDM

Generic Name: dextromethorphan hydrobromide, pseudoephedrine hydrochloride, pyrilamine maleate
Dosage Form: oral liquid

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.

Viravan-PDM

Active Ingredients (in each 5 mL)

Dextromethorphan hydrobromide 15 mg
Pseudoephedrine hydrochloride 30 mg
Pyrilamine maleate 20 mg

Purpose

Cough Suppressant
Nasal Decongestant
Antihistamine

Uses

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

  • cough due to minor throat and bronchial
  • irritation
  • reduces swelling of nasal passages
  • sinus and nasal congestion
  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes

Warnings

Do not exceed recommended dosage.

If nervousness, dizziness, or sleeplessness occur, discontinue use and consult a doctor. If symptoms do not improve within 7 days or are accompanied by fever, consult a doctor.

Do not take this product if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.

Do not use if you are 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. May cause excitability especially in children.

Do not take this product unless directed by a doctor. If you have a breathing problem such as emphysema or chronic bronchitis, or if you have glaucoma or difficulty in urination due to enlargement of the prostate gland.

When using this product
  • may cause marked drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor. Use caution when driving a motor vehicle or operating machinery.
A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.

Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.

If pregnant or breast-feeding,

ask a health professional before use.

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

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

Directions

Adults and Children 12 years of age and older: 10 mL every 6 hours, not to exceed 4 doses in a 24 hour period.
Children 6 to under 12 years of age: 5 mL every 6 hours, not to exceed 4 doses in a 24 hour period.
Children under 6 years of age: Consult a physician.

Other Information

Store at 15°C - 30°C (59°F - 86°F).

Inactive Ingredients

citric acid, glycerin, grape flavor, propylene glycol, purified water, sodium citrate, sodium saccharin, and sorbitol.

Questions? Comments?

1-866-417-9669
M-F: 8:00 a.m. - 5:00 p.m. EST
Call a doctor for medical advice. Serious side effects associated with use of this product may be reported to this number.

Viravan PDM 
dextromethorphan hydrobromide, pseudoephedrine hydrochloride, pyrilamine maleate liquid
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:23589-045
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 15 mg  in 5 mL
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg  in 5 mL
PYRILAMINE MALEATE (PYRILAMINE) PYRILAMINE MALEATE 20 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE  
GLYCERIN  
PROPYLENE GLYCOL  
WATER  
SODIUM CITRATE  
SACCHARIN SODIUM  
SORBITOL  
Product Characteristics
Color      Score     
Shape Size
Flavor GRAPE Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:23589-045-16 473 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 06/08/2010 04/30/2013
Labeler - Tiber Laboratories, LLC (008913939)
Revised: 11/2011
 
Tiber Laboratories, LLC



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