Active Ingredients
Guaifenesin 385 mg
Phenylephrine HCl 10 mg
Deconex Ir Tablet
FDA Label NDC 50991-736
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Poly Pharmaceuticals, Inc. for the product Deconex Ir (NDC 50991-736). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, stop use and ask a doctor if, ask a doctor or pharmacist before use, if pregnant or breast feeding,, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Expectorant
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
Principal Display Panelndc 50991-736-90deconex Ir Tablets90 Tablets (Deconex Ir Tablets 01)
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