Rescon JR
Name: Rescon JR
Warnings
This product may cause drowsiness or blurred vision. Patients taking this product should be warned not to engage in activities requiring mental alertness such as operating a motor vehicle or other machinery or to perform hazardous tasks while taking this drug. Sympathomimetic amines should be used with caution in patients with hypertension, ischemic heart disease, diabetes mellitus, increased intraocular pressure, hyperthyroidism, or prostatic hypertrophy. Sympathomimetic amines in overdosage may produce CNS stimulation with convulsions or cardiovascular collapse with accompanying hypotension. Do not exceed recommended dosage. Antihistamines should be used with considerable caution in pyloroduodenal obstruction; symptomatic prostatic hypertrophy; bladder neck obstruction. Antihistamines may cause excitability, especially in children. At dosages higher than the recommended dose, nervousness, dizziness or sleeplessness may occur. Do not exceed recommended dosage.
Adverse Reactions
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.
Drug Abuse and Dependence
Central nervous system stimulants such as phenylephrine have been abused. At high doses, subjects commonly experience an elevation of mood, a sense of increased energy and alertness, and decreased appetite. Some individuals become anxious, irritable and loquacious. In addition to the marked euphoria, the user experiences a sense of markedly enhanced physical strength and mental capacity. With continued use, tolerance develops, the user increases the dose, and toxic signs and symptoms appear. Depression may follow rapid withdrawal. Stimulants, such as phenylephrine, are banned and tested for by the US Olympic Committee (USOC) and the National Collegiate Athletic Association (NCAA).
Package label.principal display panel
Figure 1: 90 ct. Label
Figure 2: Blister label
Rescon JR phenylephrine hydrochloride / dexchlorpheniramine maleate tablet, multilayer, extended release | ||||||||||||||||||
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Labeler - Capellon Pharmaceuticals, LLC (124568093) |
Registrant - Capellon Pharmaceuticals, LLC (124568093) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Sovereign Pharmaceuticals, LLC | 623168267 | MANUFACTURE |
For Healthcare Professionals
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-Jr may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.