Rescon MX Tablets

Each long-acting tablet contains:

Phenylephrine Hydrochloride ….. 40 mg

Dexchlorpheniramine Maleate ….. 6 mg

Phenylephrine HCI is a sympathomimetic amine with the chemical structure: Benzenemethanol, 3- hydroxy-a-[(methylamino)methyl]- hydrochloride. It has a molecular weight of 203.67, a molecular formula of C9H13NO2 • HCI and the following structural formula:

C9H13NO2 • HCI M.W. 203.67

Dexchlorpheniramine Maleate is an antihistamine with the chemical structure: (+)-2-[p-Chloro-_-[2-(dimethylamino) ethyl]benzyl]pyridine maleate (1:1). It has a molecular weight of 390.86, a molecular formula of C16H19CIN2 • C4H4O4 and the following structural formula:

C16H19CIN2 • C4H4O4 M.W. 390.86

Calcium phosphate, hydrogenated vegetable oil, magnesium stearate, methylcellulose, povidone, stearic acid and green dye.

The following adverse reactions have been observed with the use of phenylephrine and dexchlorpheniramine: Arrhythmias, blood dyscrasias, CNS depression, CNS stimulation, dizziness, drowsiness, dryness of mouth, hallucinations, hypotension, hypertension, increased sensitivity of skin to sun, increased sweating, loss of appetite, paradoxical reaction, restlessness, skin rash, stomach upset or pain, thickening of mucus, tingling in hands or feet, trembling, troubled breathing, unusual tiredness or weakness, vomiting.

Note: Agitation; confusion; difficult or painful urination; drowsiness; dizziness; and dryness of mouth, nose or throat are more likely to occur in the elderly.

Nightmares, unusual excitement, nervousness, restlessness, or irritability are more likely to occur in children and the elderly.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Feeling nervous and excitable.
• Not able to sleep.
• Feeling sleepy.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Applies to dexchlorpheniramine / phenylephrine: oral tablet, oral tablet extended release

Gastrointestinal

Gastrointestinal side effects have included nausea, dry mouth, anorexia, and heartburn.[Ref]

Nervous system

Nervous system side effects have included headache, dizziness, mild sedation, tremor, weakness, insomnia, drowsiness, restlessness, convulsions, central nervous system depression, and nervousness.[Ref]

Genitourinary

Genitourinary side effects have included dysuria.[Ref]

Psychiatric

Psychiatric side effects have included fear, anxiety, and tenseness.[Ref]

Cardiovascular

Cardiovascular side effects have included pallor, tachycardia, palpitations, arrhythmias, and cardiovascular collapse with hypotension.[Ref]

Respiratory

Respiratory side effects have included respiratory difficulty.[Ref]

Dermatologic

Dermatologic side effects have included very rare reports of dermatitis.[Ref]

Ocular

Ocular side effects have included blurring of vision.[Ref]

Some side effects of Rescon-MX may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.