POLY-VENT IR- guaifenesin and pseudoephedrine hcl tablet 
Poly Pharmaceuticals, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Poly-Vent IR Tablets

Drug Facts

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:

Warnings

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.

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

Inactive ingredients

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

Questions? Comments?

Call 1-800-882-1041.

Manufactured for:
Poly Pharmaceuticals
Quitman, MS 39355
(800) 882-1041 Rev. 04/13

PRINCIPAL DISPLAY PANEL

NDC 50991-212-01

Poly-Vent IR Tablets

Expectorant ● Nasal Decongestant

100 tablets

front

back

POLY-VENT IR 
guaifenesin and pseudoephedrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50991-212
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN380 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE60 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
Product Characteristics
ColorblueScore2 pieces
ShapeOVALSize17mm
FlavorImprint Code POLY212
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50991-212-01100 in 1 BOTTLE; Type 0: Not a Combination Product06/11/2013
2NDC:50991-212-026 in 1 CARTON06/11/2013
22 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/11/2013
Labeler - Poly Pharmaceuticals, Inc. (198449894)
Establishment
NameAddressID/FEIBusiness Operations
TG United, Inc.172837085manufacture(50991-212)

Revised: 6/2020
Document Id: a83e1d83-cda1-7c8b-e053-2a95a90addf7
Set id: ce0d8c45-446a-4df4-a36b-5000ba69d30d
Version: 4
Effective Time: 20200616
 
Poly Pharmaceuticals, Inc.