DECONEX IR- guaifenesin and phenylephrine hcl tablet

Deconex IR by

Drug Labeling and Warnings

Deconex IR 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

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:

• 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

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

• 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

INGREDIENTS AND APPEARANCE

DECONEX IR 
guaifenesin and phenylephrine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50991-736
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	385 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	green	Score	2 pieces
Shape	OVAL	Size	17mm
Flavor		Imprint Code	POLY;716
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50991-736-02	12 in 1 CARTON	08/08/2016
1		2 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 50991-736-90	1 in 1 CARTON	08/08/2016
2		90 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	08/08/2016

Labeler - Poly Pharmaceuticals, Inc. (198449894)

Establishment
Name	Address	ID/FEI	Business Operations
TG United		172837085	manufacture(50991-736)