POLY-VENT DM- dextromethorphan hbr, guaifenesin and pseudoephedrine hcl tablet

Poly-Vent DM by

Drug Labeling and Warnings

Poly-Vent DM by is a Otc medication manufactured, distributed, or labeled by Poly Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Dextromethorphan HBr 20mg
Guaifenesin 380mg
Pseudoephedrine HCl 60mg

Purpose

Cough Suppressant

Expectorant

Nasal Decongestant

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

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.

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.

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

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 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.

Questions? Comments?

Call 1-800-882-1041.

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

PRINCIPAL DISPLAY PANEL

NDC: 50991-214-01

Poly-Vent DM Tablets

Cough Suppressant

Expectorant ● Nasal Decongestant

100 tablets

INGREDIENTS AND APPEARANCE

POLY-VENT DM 
dextromethorphan hbr, guaifenesin and pseudoephedrine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50991-214
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	60 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	380 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	yellow	Score	2 pieces
Shape	CAPSULE (Oblong)	Size	19mm
Flavor		Imprint Code	POLY214
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50991-214-02	12 in 1 CARTON	06/17/2013
1		1 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 50991-214-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	06/17/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	06/17/2013

Labeler - Poly Pharmaceuticals, Inc. (198449894)

Establishment
Name	Address	ID/FEI	Business Operations
TG United, Inc.		172837085	manufacture(50991-214)