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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 form | Strength | Route | NDCs |
|---|---|---|---|
| Tablet | 380 mg / 60 mg | oral | 1 |
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
- Class IIIDrug02/12/2025Guaifenesin and Codeine Phosphate Oral Solution USP, 100mg/10 mg per 5 mL, 16 fl oz (473 ml) bottles, PAI...PAI Holdings, LLC. dba Pharmaceutical Associates Inc · Superpotent; sodium benzoate preservative
- Class IIDrug12/18/2024Kirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets blister pack; (Acetaminophen 325mg...LNK International, Inc. · CGMP Deviations: Released product should have been rejected.
- Class IIDrug11/27/2024Guaifenesin Dextromethorphan Syrup, 200 mg/20mg per 10 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite...The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · 2 products · Failed Impurity/Degradation Specifications
- Class IIIDrugOngoing11/13/2024Adult Cough and Chest Congestion (Dextromethorphan HBr USP 20 mg, Guaifenesin USP 400mg), packaged in 4 oz...Denison Pharmaceuticals, LLC · 2 products · Crystallization: Lack of uniformity - a change in texture, chunky...
- Class IIDrugOngoing03/20/2024Broncochem Cold & Flu Syrup Kids (acetaminophen, guaifenesin, phenylephrine HCl), packaged in 120 mL...Global Corporation · Stability testing failures for one or two of the four active...
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