Poly-vent Ir Tablets

Drug Facts

Composition & Product

Active Ingredients

Guaifenesin (380 mg) Pseudoephedrine (60 mg)

Inactive Ingredients

Fd&c Blue No. 2 Magnesium Stearate Cellulose, Microcrystalline Sodium Starch Glycolate Type A Potato

Identifiers & Packaging

Pill Appearance

Imprint: POLY212 Shape: oval Color: blue Size: 17 mm Score: 2

Marketing Status

OTC MONOGRAPH DRUG Active Since 2013-06-11

Medication Information

Purpose

Expectorant

Nasal Decongestant

Description

Drug Facts

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

Section 42229-5

Drug Facts

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.

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.

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.

Questions?

Call 1-800-882-1041.

Manufactured for:

Poly Pharmaceuticals

Quitman, MS 39355

(800) 882-1041 Rev. 04/13

Other Information

Tamper evident: do not use if tamper evident seal is broken or missing. Store at 15°-30°C (59°-86°F).

Poly Vent IR Tablets are a blue, oval, scored tablet debossed POLY 212 on one side, plain on the other.

Active Ingredients

(in each tablet)

Guaifenesin 380mg

Pseudoephedrine HCl 60 mg

Inactive Ingredients

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

Principal Display Panel

NDC 50991-212-01

Poly-Vent IR Tablets

Expectorant ● Nasal Decongestant

100 tablets

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.

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

Structured Label Content

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

Section 42229-5 (42229-5)

Drug Facts

Purpose

Expectorant

Nasal Decongestant

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.

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.

Do Not Use (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.

Questions?

Call 1-800-882-1041.

Manufactured for:

Poly Pharmaceuticals

Quitman, MS 39355

(800) 882-1041 Rev. 04/13

Other Information (Other information)

Tamper evident: do not use if tamper evident seal is broken or missing. Store at 15°-30°C (59°-86°F).

Poly Vent IR Tablets are a blue, oval, scored tablet debossed POLY 212 on one side, plain on the other.

Active Ingredients (Active ingredients)

(in each tablet)

Guaifenesin 380mg

Pseudoephedrine HCl 60 mg

Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 50991-212-01

Poly-Vent IR Tablets

Expectorant ● Nasal Decongestant

100 tablets

Stop Use and Ask A Doctor If: (Stop use and ask a doctor if:)

nervousness, dizziness, or sleeplessness occur

If Pregnant Or Breast Feeding, (If pregnant or breast feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have (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

Advanced Ingredient Data

[{"name": "FD&C BLUE NO. 2", "unii": "L06K8R7DQK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A POTATO", "unii": "5856J3G2A2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GUAIFENESIN", "unii": "495W7451VQ", "classCode": "ACTIB", "strengthNumerator": "380", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "PSEUDOEPHEDRINE", "unii": "7CUC9DDI9F", "classCode": "ACTIB", "strengthNumerator": "60", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"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", "42229-5": "Drug Facts", "Purpose": "Expectorant Nasal Decongestant", "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.", "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.", "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.", "Questions?": "Call 1-800-882-1041. Manufactured for: Poly Pharmaceuticals Quitman, MS 39355 (800) 882-1041 Rev. 04/13", "Other information": "Tamper evident: do not use if tamper evident seal is broken or missing. Store at 15°-30°C (59°-86°F). Poly Vent IR Tablets are a blue, oval, scored tablet debossed POLY 212 on one side, plain on the other.", "Active ingredients": "(in each tablet) Guaifenesin 380mg Pseudoephedrine HCl 60 mg", "Inactive ingredients": "FD&C Blue #2, Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate.", "PRINCIPAL DISPLAY PANEL": "NDC 50991-212-01 Poly-Vent IR Tablets Expectorant ● Nasal Decongestant 100 tablets", "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.", "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"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information