Deconex IR Tablets

Manufacturer
Poly Pharmaceuticals, Inc.
Effective date
2024-07-09
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:15:01

Label at a glance#

ProductDeconex IR
Active ingredientGUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure11 sections

Indications and uses

Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other respiratory allergies: helps loosen phlegm and thin bronchial secretions to make coughs more productive nasal congestion runny nose sneezing itching of the nose or throat itchy, watery eyes

Dosage and administration

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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Deconex IR

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin 385 mg

Purpose

OTC - PURPOSE SECTION

Expectorant

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Phenylephrine HCl 10 mg

Purpose

OTC - PURPOSE SECTION

Nasal Decongestant

Uses

INDICATIONS & USAGE SECTION

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

  • helps loosen phlegm and thin bronchial secretions to make coughs more productive
  • nasal congestion
  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes

Warnings

WARNINGS SECTION

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

  • 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

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • nervousness, dizziness or sleeplessness occur

Ask a doctor or pharmacist before use

OTC - ASK DOCTOR/PHARMACIST SECTION

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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions:

DOSAGE & ADMINISTRATION SECTION

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

SPL UNCLASSIFIED SECTION

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

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 50991-736-90
Deconex IR
Tablets
90 Tablets

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1805155guaiFENesin 385 MG / phenylephrine HCl 10 MG Oral TabletPSN5
1805155guaifenesin 385 MG / phenylephrine hydrochloride 10 MG Oral TabletSCD5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50991-736-02Deconex IR2 in 1 BLISTER PACKTABLET25
50991-736-02Deconex IR12 in 1 CARTONTABLET125
50991-736-90Deconex IR90 in 1 BOTTLETABLET905
50991-736-90Deconex IR1 in 1 CARTONTABLET15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50991-736DECONEX IR (GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET [POLY PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 4 package rows20240711_4710095e-3dae-4a39-8a98-873012e1f003.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50991-736-90EA - Each50991-73662b96c93-445d-4a6d-bd0f-951d713ac3b112016-09-02

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50991-73650991-736-02, 50991-736-90

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Deconex IRGUAIFENESIN AND PHENYLEPHRINE HCLPoly Pharmaceuticals, Inc.4710095e-3dae-4a39-8a98-873012e1f0032024-07-09WarningsExact identifier
ndc (package): 50991-736-02
ndc (package): 50991-736-90
ndc (product): 50991-736
ndc11 (package): 50991073602
ndc11 (package): 50991073690
spl id: 1cda79a6-71f0-4793-e063-6394a90a9a8a
spl set id: 4710095e-3dae-4a39-8a98-873012e1f003

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.