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Poly-Vent IR

guaifenesin and pseudoephedrine hcl · Poly-Vent IR is an expectorant (over-the-counter) containing guaifenesin and pseudoephedrine hcl, made by Poly Pharmaceuticals, Inc..

Type
Over the counter
Drug class
Expectorant
Route
Oral
Manufacturers
1

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...

Drug facts

Generic name
guaifenesin and pseudoephedrine hcl
Active ingredients
Guaifenesin, Pseudoephedrine Hydrochloride
Drug class
Expectorant
Dosage forms
Tablet
Label holder
Poly Pharmaceuticals, Inc.
FDA application
M012
Label updated
11/09/2024

Active ingredients

(in each tablet) Guaifenesin 380mg Pseudoephedrine HCl 60 mg

Purpose

Expectorant Nasal Decongestant

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

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

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.

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

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

Nervousness, dizziness, or sleeplessness occur

Pregnancy or breastfeeding

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.

Inactive ingredients

FD&C Blue #2, Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate.

Forms and strengths

From the FDA NDC Directory · 1 product codes

Dosage formStrengthRouteNDCs
Tablet380 mg / 60 mgoral1

Manufacturers and labels

1 FDA label

  • Poly Pharmaceuticals, Inc.Shown hereM012 · Label 11/09/2024 · NDC 50991-212Full label

Related recalls

FDA drug recalls that name this drug or its active ingredient

All drug recalls

Poly-Vent IR: common questions

What is Poly-Vent IR used for?
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...
Is Poly-Vent IR a prescription drug?
No. Poly-Vent IR is sold over the counter (OTC) without a prescription.
Are there other products with the same active ingredient as Poly-Vent IR?
Yes. Other FDA-listed products with the same active ingredients include Guaifenesin and Pseudoephedrine Hcl, Guaifenesin D, Guaifenesin and Pseudoephedrine Hydrochloride, mucus d.
Who makes Poly-Vent IR?
Poly Pharmaceuticals, Inc. lists Poly-Vent IR with the FDA.

Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 11/09/2024 · Label text is shown as published by the manufacturer. Not medical advice