poly-vent dm tablets

poly-vent dm tablets
SPL v12
SPL
SPL Set ID 739329ae-0b62-4eab-a07d-867b5d3d61e0
Route
oral
Published
Effective Date 2013-06-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
pseudoephedrine (60 mg) guaifenesin (380 mg) dextromethorphan (20 mg)
Inactive Ingredients
fd&c yellow no. 5 magnesium stearate cellulose, microcrystalline sodium starch glycolate type a potato

Identifiers & Packaging

Pill Appearance
Imprint: POLY214 Shape: capsule Color: yellow Size: 19 mm Score: 2
Marketing Status
otc monograph drug active Since 2013-06-17

Purpose

Cough Suppressant Expectorant Nasal Decongestant

Description

Drug Facts


Medication Information

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.
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 associated with a cold

  • alleviates cough to help you sleep

  • non-narcotic cough suppressant for relief of cough

  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive

  • itchy, watery eyes

  • nasal congestion

  • runny nose

  • sneezing

  • itching of the nose and throat
Purpose

Cough Suppressant

Expectorant

Nasal Decongestant

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.
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 DM is a yellow, oblong, capsule shaped, scored tablet, debossed POLY 214 on one side and

blank on the other.

Inactive Ingredients

FD&C Yellow #5, Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate.

Description

Drug Facts

Principal Display Panel

NDC 50991-214-01



Poly-Vent DM Tablets



Cough Suppressant



Expectorant ● Nasal Decongestant



100 tablets

Questions?

Call 1-800-882-1041.

Manufactured for:

Poly Pharmaceuticals

Quitman, MS 39355

(800) 882-1041 Rev. 04/13

Section 42229-5

Drug Facts

Active Ingredients

Dextromethorphan HBr 20mg

Guaifenesin 380mg

Pseudoephedrine HCl 60mg

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 where cough is accompanied by excessive phlegm (mucus)

  • heart disease

  • high blood pressure

  • thyroid disease

  • diabetes

  • difficulty in urination due to enlargement of the prostate gland
Ask A Doctor Or Pharmacist Before 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.


Structured Label Content

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.
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 associated with a cold

  • alleviates cough to help you sleep

  • non-narcotic cough suppressant for relief of cough

  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive

  • itchy, watery eyes

  • nasal congestion

  • runny nose

  • sneezing

  • itching of the nose and throat
Purpose

Cough Suppressant

Expectorant

Nasal Decongestant

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.
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 DM is a yellow, oblong, capsule shaped, scored tablet, debossed POLY 214 on one side and

blank on the other.

Inactive Ingredients (Inactive ingredients)

FD&C Yellow #5, Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 50991-214-01



Poly-Vent DM Tablets



Cough Suppressant



Expectorant ● Nasal Decongestant



100 tablets

Questions?

Call 1-800-882-1041.

Manufactured for:

Poly Pharmaceuticals

Quitman, MS 39355

(800) 882-1041 Rev. 04/13

Section 42229-5 (42229-5)

Drug Facts

Active Ingredients (Active ingredients)

Dextromethorphan HBr 20mg

Guaifenesin 380mg

Pseudoephedrine HCl 60mg

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 where cough is accompanied by excessive phlegm (mucus)

  • heart disease

  • high blood pressure

  • thyroid disease

  • diabetes

  • difficulty in urination due to enlargement of the prostate gland
Ask A Doctor Or Pharmacist Before Use (Ask a doctor or pharmacist before 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.


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