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
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:64543-084
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 20 mg
DEXCHLORPHENIRAMINE MALEATE (DEXCHLORPHENIRAMINE) DEXCHLORPHENIRAMINE MALEATE 3 mg
Inactive Ingredients
Ingredient Name Strength
DIBASIC CALCIUM PHOSPHATE DIHYDRATE  
D&C YELLOW NO. 10  
MAGNESIUM STEARATE  
HYPROMELLOSE 2208 (4000 MPA.S)  
POVIDONE K30  
CELLULOSE, MICROCRYSTALLINE  
SILICON DIOXIDE  
Product Characteristics
Color YELLOW, WHITE Score 2 pieces
Shape CAPSULE Size 15mm
Flavor Imprint Code RES;JR
Contains     
Packaging
# Item Code Package Description
1 NDC:64543-084-90 90 TABLET, MULTILAYER, EXTENDED RELEASE (TABLET) in 1 BOTTLE
2 NDC:64543-084-02 2 TABLET, MULTILAYER, EXTENDED RELEASE (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 01/21/2010 04/30/2012
Labeler - Capellon Pharmaceuticals, LLC (124568093)
Registrant - Capellon Pharmaceuticals, LLC (124568093)
Establishment
Name Address ID/FEI Operations
Sovereign Pharmaceuticals, LLC 623168267 MANUFACTURE
Revised: 01/2010   Capellon Pharmaceuticals, LLC

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.

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