Prescription Drugs

CLINICAL PHARMACOLOGY No information provided.

DECONEX DMX (dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride) Tablet DESCRIPTION Drug Facts Active Ingredients Dextromethorphan HBr 17.5 mg Guaifenesin 385 mg Phenylephrine HCl 10 mg

DECONEX DM (dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride) Capsule DESCRIPTION Drug Facts Active Ingredients (in each capsule) Dextromethorphan HBr 15 mg Guaifenesin 390 mg Phenylephrine HCl 10 mg

INDICATIONS Purpose (in each tablet) Cough Suppressant Expectorant Nasal Decongestant Uses Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: cough due to minor throat and bronchial irritation helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive nasal congestion reduces swelling of nasal passages 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. Children under 6 years of age: Consult a physician. HOW SUPPLIED Other Information Store at controlled room temperature between 15°-30°C (59°-86°F). Supplied in a tight, light-resistant container with a child-resistant cap. Deconex DMX Tablets are orange, oblong, capsule-shaped, scored tablets, debossed "POLY" bisect "730" on one side and blank on the other side. NDC 50991-738-90 Inactive Ingredients FD&C Yellow No. 6, D&C Yellow No. 10, 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

INDICATIONS Purpose Cough Suppressant Expectorant Nasal Decongestant Uses Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: cough due to minor throat and bronchial irritation helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive nasal congestion reduces swelling of nasal passages DOSAGE AND ADMINISTRATION Directions Do not exceed recommended dosage. Adults and children 12 years of age and over: 1 capsule every 4 hours, not to exceed 6 capsules in 24 hours. Children under 12 years of age: Consult a physician. HOW SUPPLIED Other Information Store at controlled room temperature between 15°-30°C (59°-86°F). Supplied in a tight, light-resistant container with a child-resistant cap. NDC 50991-583-60 Deconex DM Capsules are purple-yellow capsules imprinted "Deconex DM" in black ink. Contains color additives including FD&C Yellow No. 5 (tartrazine). Inactive Ingredients Croscarmellose Sodium, Dicalcium Phosphate Dihydrate, FD&C Blue #1, FD&C Red #3, FD&C Yellow #5, FD&C Yellow #6, Gelatin, Magnesium Stearate, Maltodextrin, Povidone, Silicon Dioxide, Stearic Acid, and Titanium Dioxide. Questions? Comments? Call 1-800-882-1041 Manufactured for: Poly Pharmaceuticals, Quitman, MS 39355, 1 (800) 882-1041. Revised: Nov 2011

PATIENT INFORMATION Do not exceed recommended dosage. Do not use this product 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. Ask a doctor before use if you have a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema a cough that occurs with too much phlegm (mucus) heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition. new symptoms occur 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.

PATIENT INFORMATION Do not exceed recommended dosage. Do not use this product 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. Ask a doctor before use if you have a cough that last or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema a cough that occurs with too much phlegm (mucus) heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur cough, or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition. new symptoms occur 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. Do not use this product 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. Ask a doctor before use if you have a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema a cough that occurs with too much phlegm (mucus) heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition. new symptoms occur 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.

WARNINGS Included as part of the PRECAUTIONS section. PRECAUTIONS Do not exceed recommended dosage. Do not use this product 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. Ask a doctor before use if you have a cough that last or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema a cough that occurs with too much phlegm (mucus) heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur cough, or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition. new symptoms occur 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.