Prescription Drugs

CLINICAL PHARMACOLOGY No information provided.

DECONEX IR (guaifenesin and phenylephrine hcl) Tablet DESCRIPTION Drug Facts Active Ingredients Guaifenesin 385 mg Phenylephrine HCl 10 mg

INDICATIONS Purpose (in each tablet) 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 DOSAGE AND ADMINISTRATION Directions Do not exceed recommended dosage. Adults and children 12 years of age and over: 1 tablet every 4 hours, not to exceed 6 tablets in 24 hours. Children 6 to under 12 years of age: ½ tablet every 4 hours, not to exceed 3 tablets in 24 hours or as directed by a doctor.. Children under 6 years of age: Consult a physician. HOW SUPPLIED 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. NDC 50991-736-90 Inactive Ingredients FD&C Yellow No. 5, FD&C Blue No. 1, magnesium stearate, microcrystalline cellulose, sodium starch glycolate. Questions? Comments? Call 1-800-882-1041 Manufactured for: Poly Pharmaceuticals, Huntsville, AL 35763. 1(800) 882-1041. Revised: Jun 2016

PATIENT INFORMATION 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.

OVERDOSE No information provided. CONTRAINDICATIONS No information provided.

SIDE EFFECTS No information provided. Please see the WARNINGS AND PRECAUTIONS sections DRUG INTERACTIONS No information provided.

WARNINGS Included as part of the PRECAUTIONS section. PRECAUTIONS 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.