Drugplain

Poly-Vent IR 380 mg/1

Guaifenesin and Pseudoephedrine HCl · TABLET · Poly Pharmaceuticals, Inc.

1 Recall on Record
Plain English

Poly-Vent IR is a prescription tablet containing guaifenesin and pseudoephedrine hcl at 380 mg/1, taken oral. Manufactured by Poly Pharmaceuticals, Inc..

Key Facts

Brand Name
Poly-Vent IR
Generic Name
Guaifenesin and Pseudoephedrine HCl
NDC Code (Product)
50991-212
Manufacturer
Poly Pharmaceuticals, Inc.
Strength
380 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
HUMAN OTC DRUG
Application #
M012
Drug Class
Adrenergic alpha-Agonists [MoA]; Decreased Respiratory Secretion Viscosity [PE]
Marketing Start
06/11/2013

Recall History

1 Recall on Record
Class II01/30/2013

TG United, Inc.

CGMP Deviations: Products are underdosed or have an incorrect dosage regime.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

alanine aminotransferase increased1 reports
arthritis1 reports
aspartate aminotransferase increased1 reports
blood alkaline phosphatase increased1 reports
blood chloride decreased1 reports
blood cholesterol increased1 reports
blood sodium decreased1 reports
bronchitis1 reports
cholelithiasis1 reports
deep vein thrombosis1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: helps loosen phlegm and thin bronchial secretions to make coughs more productive nasal congestion runny nose sneezing itching of the nose and throat itchy, watery eyes

Dosage & Administration

Directions Adults and children 12 years of age and over: 1 tablet every 4 hours, not to exceed 4 tablets in 24 hours, or as directed by a doctor. Children age 6 to under 12 years of age: ½ tablet every 4 hours, not to exceed 2 tablets in 24 hours, or as directed by a doctor. Children 2 to under 6 years of age: Consult a doctor.

Warnings

Warnings Do not exceed recommended dosage. 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 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. Ask a doctor before use if you have a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or if cough is accompanied by excessive phlegm heart disease high blood pressure thyroid disease diabetes difficulty in urination due to enlargement of the prostate gland Stop use and ask a doctor if: nervousness, dizziness, or sleeplessness occur If pregnant or breast feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Frequently Asked Questions

What is Poly-Vent IR used for?

Poly-Vent IR contains Guaifenesin and Pseudoephedrine HCl. It is a tablet taken oral. Consult your doctor for specific uses.

Is Poly-Vent IR a controlled substance?

Poly-Vent IR is not classified as a controlled substance by the DEA.

What is the generic name for Poly-Vent IR?

The generic name for Poly-Vent IR is Guaifenesin and Pseudoephedrine HCl. There are 11 other brand versions of Guaifenesin and Pseudoephedrine HCl.

What is the NDC code for Poly-Vent IR 380 mg/1?

The NDC (National Drug Code) for Poly-Vent IR 380 mg/1 is 50991-212, listed by Poly Pharmaceuticals, Inc..