DECONEX IR- guaifenesin and phenylephrine hcl tablet 
Poly Pharmaceuticals, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Deconex IR Tablets

Deconex IR

Drug Facts

Active ingredients

Guaifenesin 385 mg

Purpose

Expectorant

Active ingredients

Phenylephrine HCl 10 mg

Purpose

Nasal Decongestant

Uses

Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other respiratory allergies:

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 before use if you have

Ask a doctor before use if you are taking sedatives or tranquilizers.

Stop use and ask a doctor if

  • nervousness, dizziness or sleeplessness occur

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.

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 older: 1 tablet every 4 hours, not to exceed 6 tablets in 24 hours.

Children age 6 to 12 years of age: 1/2 tablet every 4 hours, not to exceed 3 tablets in 24 hours or as directed by a doctor.

Children 6 years of age and younger: Consult a physician.

Other information

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

Deconex IR Tablets are a green, oval, scored tablet debossed POLY 716 on one side, plain on the other.

Inactive ingredients

FD&C Yellow No. 5, FD&C Blue No. 1, magnesium stearate, microcrystalline cellulose, sodium starch glycolate.

Manufactured for:
Poly Pharmaceuticals
Huntsville, AL 35763
(800) 882-1041
Rev. 06/16

PRINCIPAL DISPLAY PANEL

NDC 50991-736-90
Deconex IR
Tablets
90 Tablets

PRINCIPAL DISPLAY PANEL
NDC 50991-736-90
Deconex IR 
Tablets
90 Tablets

DECONEX IR 
guaifenesin and phenylephrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50991-736
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN385 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
Product Characteristics
ColorgreenScore2 pieces
ShapeOVALSize17mm
FlavorImprint Code POLY;716
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50991-736-0212 in 1 CARTON08/08/2016
12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:50991-736-901 in 1 CARTON08/08/2016
290 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/08/2016
Labeler - Poly Pharmaceuticals, Inc. (198449894)

Revised: 1/2024
Document Id: 0ff2ffe0-e7cb-b361-e063-6294a90a5148
Set id: 4710095e-3dae-4a39-8a98-873012e1f003
Version: 4
Effective Time: 20240127
 
Poly Pharmaceuticals, Inc.