Prescription Drug Information: Rescon MX (Page 2 of 2)

Carcinogenesis, Mutagenesis, Impairment of Fertility

No data are available on the long-term potential of the components of this product for carcinogenesis, mutagenesis or impairment of fertility in animals or humans.

Pregnancy

Pregnancy Category C: Reproduction studies have been performed with chlorpheniramine maleate. Studies in rabbits and rats at doses up to 50 times and 85 times the human dose revealed no evidence of harm to the fetus. There are, however, no adequate and well controlled studies in pregnant women. Therefore, it is not known whether these drugs can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Animal reproduction studies have not been conducted with phenylephrine.

This product should be given to a pregnant woman only if clearly needed.

Labor and Delivery

Use of phenylephrine during labor may cause fetal anoxia and bradycardia by increasing contractility of the uterus and decreasing uterine blood flow.

Nursing Mothers

Small amounts of sympathomimetic amines and antihistamines are excreted in breast milk; use is not recommended because of the risk of adverse effects, such as unusual excitement or irritability, in infants. Anticholinergics and antihistamines may inhibit lactation.

Pediatric Use

Use of antihistamines is not recommended in newborn or premature infants because this age group has an increased susceptibility to anticholinergic side effects, such as CNS excitation, and an increased tendency toward convulsion. In infants and children, overdosage may cause hallucinations, convulsions, and death. A paradoxical reaction characterized by hyper-excitability may occur in older children taking antihistamines. Use is not recommended for children under twelve years of age.

Appropriate studies with phenylephrine have not been performed in the pediatric population; however, no pediatric-specific problems have been documented to date.

Geriatric Use

Confusion, hallucinations, seizures and CNS depression may be more likely to occur in geriatric patients taking sympathomimetic amines. Geriatric patients also may be more sensitive to the effects, especially the vasopressor effects, of sympathomimetic amines. Confusion, dizziness, sedation, hypotension, hyperexcitability, and anticholinergic side effects, such as dryness of mouth and urinary retention (especially in males), may be more likely to occur in geriatric patients taking antihistamines.

Geriatric patients may respond to usual doses of anticholinergics with excitement, agitation, drowsiness, or confusion. Geriatric patients are especially susceptible to the anticholinergic side effects, such as constipation, dryness of mouth, and urinary retention (especially in males). If these side effects occur and continue or are severe, medication should probably be discontinued. Caution is also recommended when anticholinergics are given to geriatric patients, because of the danger of precipitating undiagnosed glaucoma. Memory may become severely impaired in geriatric patients, especially those who already have memory problems, with the continued use of anticholinergics, since these drugs block the action of acetylcholine, which is responsible for many functions of the brain, including memory function.

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 U S Olympic Committee (USOC) and the National Collegiate Athletic Association (NCAA).

OVERDOSAGE

This product is comprised of pharmacologically different components (sympathomimetic amine, and antihistamine). Therefore, it is difficult to predict the exact manifestation of symptoms in a given individual.

Reaction to an overdose of this product may vary from CNS depression to stimulation. A description of symptoms which are likely to appear after ingestion of an excess of the individual components follows:

• Overdosage with sympathomimetic amines can cause cardiac arrhythmias, cerebral hemorrhage and pulmonary edema. It can also cause palpitations, tremor, dizziness, vomiting, fear, labored breathing, headache, dryness of mouth, pallor, weakness, panic, anxiety, confusion, and hallucination.

• Manifestation of antihistamine overdosage may vary from CNS depression to stimulation. Other signs and symptoms may be dizziness, tinnitus, ataxia, blurred vision, and hypotension.

Stimulation is particularly likely in children as are atropine-like signs and symptoms (dry mouth, fixed, dilated pupils, flushing, hyperthermia, and gastrointestinal symptoms). In infants and children particularly, antihistamines, in overdosage may produce convulsion and/or death.

Treatment of acute overdosage would probably be based upon treating the patient for phenylephrine toxicity which may manifest itself as excessive CNS stimulation resulting in excitement, tremor, restlessness, and insomnia. Other effects may include hyperpyrexia, hypertension, mydriasis, hyperglycemia and urinary retention. Severe overdosage may cause tachypnea or hyperpnea, convulsions or delirium, but in some individuals there may be CNS depression with somnolence, stupor, or respiratory depression.

Arrhythmias may lead to hypotension and circulatory collapse. Severe hypokalemia can occur, probably due to a compartmental shift rather than a depletion of potassium. No organ damage or significant metabolic derangement is associated with overdosage.

General Treatment: Treatment is symptomatic and supportive with possible utilization of the following:

• Induction of emesis (syrup of Ipecac recommended); however, precaution against aspiration is necessary, especially in infants and children.

• Gastric lavage (isotonic or 0.45% sodium chloride solution) if patient is unable to vomit within three hours of ingestion.

• Saline cathartics (milk of magnesia) may be used.

• Vasopressors to treat hypotension; however, epinephrine should not be used since it may further lower blood pressure.

• For excessive hypertensive effect an α-adrenergic blocker, such as phentolamine, may be administered.

• Hyperpyrexia, especially in children, may require treatment by means of external cooling.

• Excessive CNS stimulation may be counteracted with parenteral diazepam.

• Oxygen and intravenous fluids.

• Precaution against the use of stimulants (analeptic agents) is recommended because they may cause seizures.

• Excitement to a degree which demands attention may be managed with sodium thiopental 2% solution given slowly intravenously or chloral hydrate (100 — 200 mL of a 2% solution) by rectal infusion.

In severe cases of overdosage it is essential to monitor both the heart (by electrocardiograph) and plasma electrolytes, and to give intravenous potassium as indicated. In the event of progression of the curare-like effect to paralysis of the respiratory muscles or apnea, artificial respiration should be instituted and maintained until effective respiratory action returns.

DOSAGE AND ADMINISTRATION

Adults and adolescents 12 years of age and older: One (1) tablet every 12 hours.

Not recommended for children under 12 years of age. Do not crush or chew tablets prior to swallowing.

Note: Geriatric patients may be more sensitive to the effects of the usual adult dose. Adjust adult dose accordingly.

HOW SUPPLIED

Supplied as green & white, bilayered, capsule-shaped tablets debossed “RES MX” on one side, scored on the opposite. Available in bottles of 90 tablets, NDC 64543-091-90, and sample packs of 2 tablets, NDC 64543-091-02.

KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTALOVERDOSE, CALL A DOCTOR OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

Storage and Handling

Dispense in tight, light-resistant containers as defined in the USP/NF, with child resistant closures. Store at controlled room temperature between 20°-25°C (68°-77°F); see USP Controlled Room Temperature.

Avoid exposure to heat.

Call Your Doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Manufactured for:

Capellon Pharmaceuticals, LLC

Fort Worth, TX 76118

500389 Rev. 01/2010

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

fbe45a86-figure-03
(click image for full-size original)

Figure 1: 90 ct. Label

fbe45a86-figure-04
(click image for full-size original)

Figure 2: Blister label

RESCON MX
phenylephrine hydrochloride / dexchlorpheniramine maleate tablet, multilayer, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64543-091
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 40 mg
DEXCHLORPHENIRAMINE MALEATE (DEXCHLORPHENIRAMINE) DEXCHLORPHENIRAMINE MALEATE 6 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE
MAGNESIUM STEARATE
HYPROMELLOSE 2208 (4000 MPA.S)
POVIDONE K30
STEARIC ACID
D&C YELLOW NO. 10
FD&C BLUE NO. 1
Product Characteristics
Color WHITE, GREEN Score 2 pieces
Shape CAPSULE Size 15mm
Flavor Imprint Code RES;MX
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64543-091-90 90 TABLET, MULTILAYER, EXTENDED RELEASE (TABLET) in 1 BOTTLE None
2 NDC:64543-091-02 2 TABLET, MULTILAYER, EXTENDED RELEASE (TABLET) in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 01/21/2010 04/30/2013
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

Page 2 of 2 1 2

RxDrugLabels.com provides trustworthy package insert and label information about marketed prescription drugs as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by RxDrugLabels.com. Every individual prescription drug label and package insert entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.

Medication Sections

Medication Information by RSS

As a leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. RxDrugLabels.com provides the full prescription-only subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2020. All Rights Reserved.