Codeine Phosphate and Chlorpheniramine Maleate Extended Release Tablets, CIII

Use of codeine, an opioid, may result in the following:

• Respiratory depression [see WARNINGS AND PRECAUTIONS and OVERDOSAGE]
• Drug dependence [see WARNINGS AND PRECAUTIONS]
• Increased intracranial pressure [see WARNINGS AND PRECAUTIONS]
• Decreased mental alertness with impaired mental and/or physical abilities [see WARNINGS AND PRECAUTIONS]
• Paralytic ileus [see WARNINGS AND PRECAUTIONS]

Use of chlorpheniramine, an antihistamine, may result in:

• Decreased mental alertness with impaired mental and/or physical abilities [see WARNINGS AND PRECAUTIONS]

Adverse reactions listed below have been reported in the literature for codeine and chlorpheniramine and may be expected to occur with TUXARIN ER. Also included are events that occurred during clinical pharmacokinetic studies (in a total of 66 healthy adult volunteers with either single or multiple dose exposure) with TUXARIN ER and judged by the investigator to be related to study treatment. Because these reactions may be reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Allergic laryngospasm, nasal stuffiness, bronchospastic allergic reaction, hives, itching, swelling of face.

Asthenia, feeling of relaxation, redness or flushing of the face, unusual tiredness, weakness. Cardiovascular: Fast, or slow heartbeat, hypertension, hypotension, orthostatic hypotension, palpitations, shock-like state, syncope.

Skin rash, pruritus, erythema, urticaria, excessive perspiration, dermatitis.

Changes in glucose utilization, decreased lactation, early menses, glycosuria, gynecomastia, hypoglycemia, increased appetite, increased libido, pheochromocytoma stimulation.

Nausea and vomiting,, constipation, abdominal distension, abdominal pain, acute pancreatitis, dry mouth, dyspepsia, epigastric distress, loss of appetite, diarrhea, gastro-esophageal reflux, gastrointestinal hypomotility.

Ureteral spasm, urinary retention, dysuria, urinary frequency, urinary hesitancy, irritative bladder symptom.

Blurred vision, diplopia, visual disturbances, confusion, dizziness, depression, drowsiness, sedation, headache, euphoria, facial dyskinesia, false sense of well-being, feeling faint, lightheadedness, general feeling of discomfort or illness, excitability nervousness, agitation, restlessness, somnolence, insomnia, dyskinesia, irritability, tremor.

Dryness of the pharynx and respiratory passages, laryngismus, atelectasis, wheezing, troubled breathing, respiratory depression, hiccups.

labyrinthitis, tinnitus, vertigo, hypermetropia, lacrimation increased, mydriasis, photophobia.