Phensedyl Dry Family Cough

Promethazine Hydrochloride:

• Indications and usage
• Contraindications
• Warnings
• Use in pediatric patients
• Other considerations
• Precautions
• Adverse reactions
• Drug abuse and dependence
• Overdosage
• Dosage and administration
• How supplied
• Phensedyl Dry Family Cough (Promethazine Hydrochloride) reviews

INDICATIONS AND USAGE

Phensedyl Dry Family Cough (Promethazine Hydrochloride) with codeine syrup is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold.

CONTRAINDICATIONS

The combination of Phensedyl Dry Family Cough (Promethazine Hydrochloride) hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age, because the combination may cause fatal respiratory depression in this age population.

Codeine is contraindicated in patients with a known hypersensitivity to the drug.

Phensedyl Dry Family Cough (Promethazine Hydrochloride) is contraindicated in comatose states, and in individuals known to be hypersensitive or to have had an idiosyncratic reaction to Phensedyl Dry Family Cough (Promethazine Hydrochloride) or to other phenothiazines.

Antihistamines and codeine are both contraindicated for use in the treatment of lower respiratory tract symptoms, including asthma.

WARNINGS

WARNING:

The combination of Phensedyl Dry Family Cough hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age. Concomitant administration of Phensedyl Dry Family Cough (Promethazine Hydrochloride) products with other respiratory depressants has an association with respiratory depression, and sometimes death, in pediatric patients.

Postmarketing cases of respiratory depression, including fatalities, have been reported with use of Phensedyl Dry Family Cough (Promethazine Hydrochloride) hydrochloride in pediatric patients less than 2 years of age. A wide range of weight-based doses of Phensedyl Dry Family Cough (Promethazine Hydrochloride) hydrochloride have resulted in respiratory depression in these patients.

Codeine:

Dosage of codeine SHOULD NOT BE INCREASED if cough fails to respond; an unresponsive cough should be reevaluated in 5 days or sooner for possible underlying pathology, such as foreign body or lower respiratory tract disease.

Codeine may cause or aggravate constipation.

Respiratory depression leading to arrest, coma, and death has occurred with the use of codeine antitussives in young children, particularly in the under-one-year infants whose ability to deactivate the drug is not fully developed.

Administration of codeine may be accompanied by histamine release and should be used with caution in atopic children.

Head Injury And Increased Intracranial Pressure:

The respiratory-depressant effects of narcotic analgesics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, intracranial lesions or a pre-existing increase in intracranial pressure. Narcotics may produce adverse reactions which may obscure the clinical course of patients with head injuries.

Asthma And Other Respiratory Conditions:

Narcotic analgesics or cough suppressants, including codeine, should not be used in asthmatic patients. Nor should they be used in acute febrile illness associated with productive cough or in chronic respiratory disease where interference with ability to clear the tracheobronchial tree of secretions would have a deleterious effect on the patient's respiratory function.

Hypotensive Effect:

Codeine may produce orthostatic hypotension in ambulatory patients.

Phensedyl Dry Family Cough :

CNS Depression –

Phensedyl Dry Family Cough may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. The impairment may be amplified by concomitant use of other central-nervous-system depressants such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore, such agents should either be eliminated or given in reduced dosage in the presence of Phensedyl Dry Family Cough (Promethazine Hydrochloride) HCl (see PRECAUTIONS - Information For Patients and Drug Interactions ).

Respiratory Depression –

Phensedyl Dry Family Cough (Promethazine Hydrochloride) may lead to potentially fatal respiratory depression.

Use of Phensedyl Dry Family Cough (Promethazine Hydrochloride) in patients with compromised respiratory function (e.g., COPD, sleep apnea) should be avoided.

Lower Seizure Threshold –

Phensedyl Dry Family Cough may lower seizure threshold. It should be used with caution in persons with seizure disorders or in persons who are using concomitant medications, such as narcotics or local anesthetics, which may also affect seizure threshold.

Bone-Marrow Depression –

Phensedyl Dry Family Cough (Promethazine Hydrochloride) should be used with caution in patients with bone marrow depression. Leukopenia and agranulocytosis have been reported, usually when Phensedyl Dry Family Cough (Promethazine Hydrochloride) HCl has been used in association with other known marrow-toxic agents.

Neuroleptic Malignant Syndrome –

A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with Phensedyl Dry Family Cough (Promethazine Hydrochloride) HCl alone or in combination with antipsychotic drugs. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmias).

The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis, it is important to identify cases where the clinical presentation includes both serious medical illness (e.g., pneumonia, systemic infection, etc.) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever and primary central nervous system (CNS) pathology.

The management of NMS should include 1) immediate discontinuation of Phensedyl Dry Family Cough (Promethazine Hydrochloride) HCl, antipsychotic drugs, if any, and other drugs not essential to concurrent therapy, 2) intensive symptomatic treatment and medical monitoring, and 3) treatment of any concomitant serious medical problems for which specific treatments are available. There is no general agreement about specific pharmacological treatment regimens for uncomplicated NMS.

Since recurrences of NMS have been reported with phenothiazines, the reintroduction of Phensedyl Dry Family Cough (Promethazine Hydrochloride) HCl should be carefully considered.

Use In Pediatric Patients

The combination of Phensedyl Dry Family Cough (Promethazine Hydrochloride) hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age. Concomitant administration of Phensedyl Dry Family Cough (Promethazine Hydrochloride) products with other respiratory depressants has an association with respiratory depression, and sometimes death, in pediatric patients. The association does not directly relate to individualized weight-based dosing, which might otherwise permit safe administration.

Excessively large dosages of antihistamines, including Phensedyl Dry Family Cough (Promethazine Hydrochloride) hydrochloride, in pediatric patients may cause sudden death (see OVERDOSAGE ). Hallucinations and convulsions have occurred with therapeutic doses and overdoses of Phensedyl Dry Family Cough (Promethazine Hydrochloride) hydrochloride in pediatric patients. In pediatric patients who are acutely ill associated with dehydration, there is an increased susceptibility to dystonias with the use of Phensedyl Dry Family Cough (Promethazine Hydrochloride) HCl.

Other Considerations

Administration of Phensedyl Dry Family Cough (Promethazine Hydrochloride) has been associated with reported cholestatic jaundice.

PRECAUTIONS

Animal reproduction studies have not been conducted with the drug combination-promethazine and codeine. It is not known whether this drug combination can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Phensedyl Dry Family Cough hydrochloride and codeine phosphate should be given to a pregnant woman only if clearly needed.

General:

Narcotic analgesics, including codeine, should be administered with caution and the initial dose reduced in patients with acute abdominal conditions, convulsive disorders, significant hepatic or renal impairment, fever, hypothyroidism, Addison's disease, ulcerative colitis, prostatic hypertrophy, in patients with recent gastrointestinal or urinary tract surgery, and in the very young or elderly or debilitated patients.

Drugs having anticholinergic properties should be used with caution in patients with narrow-angle glaucoma, prostatic hypertrophy, stenosing peptic ulcer, pyloroduodenal obstruction, and bladder-neck obstruction.

Phensedyl Dry Family Cough (Promethazine Hydrochloride) should be used cautiously in persons with cardiovascular disease or with impairment of liver function.

Ultra-Rapid Metabolizers of Codeine

Some individuals may be ultra-rapid metabolizers due to a specific CYP2D6*2x2 genotype. These individuals convert codeine into its active metabolite, morphine, more rapidly and completely than other people. This rapid conversion results in higher than expected serum morphine levels. Even at labeled dosage regimens, individuals who are ultra-rapid metabolizers may experience overdose symptoms such as extreme sleepiness, confusion, or shallow breathing.

The prevalence of this CYP2D6 phenotype varies widely and has been estimated at 0.5 to 1% in Chinese and Japanese, 0.5 to 1% in Hispanics, 1–10% in Caucasians, 3% in African Americans, and 16–28% in North Africans, Ethiopians and Arabs. Data is not available for other ethnic groups.

When physicians prescribe codeine-containing drugs, they should choose the lowest effective dose for the shortest period of time and should inform their patients about these risks and the signs of morphine overdose.

Information For Patients:

Patients should be advised to measure Phensedyl Dry Family Cough (Promethazine Hydrochloride) with codeine syrup with an accurate measuring device. A household teaspoon is not an accurate measuring device and could lead to overdosage, especially when a half a teaspoon is measured. A pharmacist can recommend an appropriate measuring device and can provide instructions for measuring the correct dose.

Phensedyl Dry Family Cough (Promethazine Hydrochloride) and codeine may cause marked drowsiness or may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. Ambulatory patients should be told to avoid engaging in such activities until it is known that they do not become drowsy or dizzy from Phensedyl Dry Family Cough (Promethazine Hydrochloride) and codeine therapy. Pediatric patients should be supervised to avoid potential harm in bike riding or in other hazardous activities.

The concomitant use of alcohol or other central-nervous-system depressants, such as sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers may enhance impairment and should be avoided or their dosage reduced (see WARNINGS -CNS Depression and PRECAUTIONS-Drug Interactions ).

Patients should be advised to report any involuntary muscle movements.

Avoid prolonged exposure to the sun.

Codeine, like other narcotic analgesics, may produce orthostatic hypotension in some ambulatory patients. Patients should be cautioned accordingly.

Caution patients that some people have a variation in a liver enzyme and change codeine into morphine more rapidly and completely than other people. These people are ultra-rapid metabolizers and are more likely to have higher-than-normal levels of morphine in their blood after taking codeine which can result in overdose symptoms such as extreme sleepiness, confusion, or shallow breathing. In most cases, it is unknown if someone is an ultra-rapid codeine metabolizer.

Nursing mothers taking codeine can also have higher morphine levels in their breast milk if they are ultra-rapid metabolizers. These higher levels of morphine in breast milk may lead to life-threatening or fatal side effects in nursing babies. Instruct nursing mothers to watch for signs of morphine toxicity in their infants including increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties, or limpness. Instruct nursing mothers to talk to the baby's doctor immediately if they notice these signs and, if they cannot reach the doctor right away, to take the baby to an emergency room or call 911 (or local emergency services).

Drug Interactions:

Codeine:

In patients receiving MAO inhibitors, an initial small test dose is advisable to allow observation of any excessive narcotic effects or MAOI interaction.

Phensedyl Dry Family Cough :

CNS Depressants –

Phensedyl Dry Family Cough may increase, prolong, or intensify the sedative action of other central-nervous-system depressants, such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore, such agents should be avoided or administered in reduced dosage to patients receiving Phensedyl Dry Family Cough (Promethazine Hydrochloride) HCl. When given concomitantly with Phensedyl Dry Family Cough (Promethazine Hydrochloride), the dose of barbiturates should be reduced by at least one-half, and the dose of narcotics should be reduced by one-quarter to one-half. Dosage must be individualized. Excessive amounts of Phensedyl Dry Family Cough (Promethazine Hydrochloride) HCl relative to a narcotic may lead to restlessness and motor hyperactivity in the patient with pain; these symptoms usually disappear with adequate control of the pain.

Epinephrine –

Because of the potential for Phensedyl Dry Family Cough (Promethazine Hydrochloride) to reverse epinephrine's vasopressor effect, epinephrine should NOT be used to treat hypotension associated with Phensedyl Dry Family Cough (Promethazine Hydrochloride) overdose.

Anticholinergics –

Concomitant use of other agents with anticholinergic properties should be undertaken with caution.

Monoamine Oxidase Inhibitors –

Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly.

Drug/Laboratory Test Interactions:

Because narcotic analgesics may increase biliary tract pressure with resultant increases in plasma amylase or lipase levels, determination of these enzyme levels may be unreliable for 24 hours after a narcotic analgesic has been given.

The following laboratory tests may be affected in patients who are receiving therapy with Phensedyl Dry Family Cough hydrochloride.

Pregnancy Tests:

Diagnostic pregnancy tests based on immunological reactions between HCG and anti-HCG may result in false-negative or false-positive interpretations.

Glucose Tolerance Test:

An increase in blood glucose has been reported in patients receiving Phensedyl Dry Family Cough.

Carcinogenesis, Mutagenesis, Impairment Of Fertility:

Long-term animal studies have not been performed to assess the carcinogenic potential of codeine or of Phensedyl Dry Family Cough (Promethazine Hydrochloride), nor are there other animal or human data concerning carcinogenicity, mutagenicity, or impairment of fertility with these agents. Codeine has been reported to show no evidence of carcinogenicity or mutagenicity in a variety of test systems, including the micronucleus and sperm abnormality assays and the Salmonella assay. Phensedyl Dry Family Cough (Promethazine Hydrochloride) was nonmutagenic in the Salmonella test system of Ames.

Pregnancy:

Teratogenic Effects - Pregnancy Category C.

Codeine:

A study in rats and rabbits reported no teratogenic effect of codeine administered during the period of organogenesis in doses ranging from 5 to 120 mg/kg. In the rat, doses at the 120-mg/kg level, in the toxic range for the adult animal, were associated with an increase in embryo resorption at the time of implantation. In another study a single 100-mg/kg dose of codeine administered to pregnant mice reportedly resulted in delayed ossification in the offspring.

There are no studies in humans, and the significance of these findings to humans, if any, is not known.

Phensedyl Dry Family Cough :

Teratogenic effects have not been demonstrated in rat-feeding studies at doses of 6.25 and 12.5 mg/kg of Phensedyl Dry Family Cough (Promethazine Hydrochloride) HCl. These doses are from approximately 2.1 to 4.2 times the maximum recommended total daily dose of Phensedyl Dry Family Cough (Promethazine Hydrochloride) for a 50-kg subject, depending upon the indication for which the drug is prescribed. Daily doses of 25 mg/kg intraperitoneally have been found to produce fetal mortality in rats.

Specific studies to test the action of the drug on parturition, lactation, and development of the animal neonate were not done, but a general preliminary study in rats indicated no effect on these parameters. Although antihistamines have been found to produce fetal mortality in rodents, the pharmacological effects of histamine in the rodent do not parallel those in man. There are no adequate and well-controlled studies of Phensedyl Dry Family Cough (Promethazine Hydrochloride) in pregnant women.

Phensedyl Dry Family Cough (Promethazine Hydrochloride) and codeine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nonteratogenic Effects -

Dependence has been reported in newborns whose mothers took opiates regularly during pregnancy. Withdrawal signs include irritability, excessive crying, tremors, hyperreflexia, fever, vomiting, and diarrhea. Signs usually appear during the first few days of life.

Phensedyl Dry Family Cough administered to a pregnant woman within two weeks of delivery may inhibit platelet aggregation in the newborn.

Labor And Delivery:

Narcotic analgesics cross the placental barrier. The closer to delivery and the larger the dose used, the greater the possibility of respiratory depression in the newborn. Narcotic analgesics should be avoided during labor if delivery of a premature infant is anticipated. If the mother has received narcotic analgesics during labor, newborn infants should be observed closely for signs of respiratory depression. Resuscitation may be required (see OVERDOSAGE ).

Limited data suggest that use of Phensedyl Dry Family Cough (Promethazine Hydrochloride) hydrochloride during labor and delivery does not have an appreciable effect on the duration of labor or delivery and does not increase the risk of need for intervention in the newborn.

The effect of Phensedyl Dry Family Cough (Promethazine Hydrochloride) and/or codeine on the later growth and development of the newborn is unknown.

Nursing Mothers:

It is not known whether Phensedyl Dry Family Cough is excreted in human milk.

Codeine is secreted into human milk. In women with normal codeine metabolism (normal CYP2D6 activity), the amount of codeine secreted into human milk is low and dose-dependent. Despite the common use of codeine products to manage postpartum pain, reports of adverse events in infants are rare. However, some women are ultra-rapid metabolizers of codeine. These women achieve higher-than-expected serum levels of codeine's active metabolite, morphine, leading to higher-than-expected levels of morphine in breast milk and potentially dangerously high serum morphine levels in their breastfed infants. Therefore, maternal use of codeine can potentially lead to serious adverse reactions, including death, in nursing infants.

The prevalence of this CYP2D6 phenotype varies widely and has been estimated at 0.5 to 1% in Chinese and Japanese, 0.5 to 1% in Hispanics, 1–10% in Caucasians, 3% in African Americans, and 16–28% in North Africans, Ethiopians and Arabs. Data is not available for other ethnic groups.

The risk of infant exposure to codeine and morphine through breast milk should be weighed against the benefits of breastfeeding for both the mother and baby. Caution should be exercised when codeine is administered to a nursing woman. If a codeine-containing product is selected, the lowest dose should be prescribed for the shortest period of time to achieve the desired clinical effect. Mothers using codeine should be informed about when to seek immediate medical care and how to identify the signs and symptoms of neonatal toxicity, such as drowsiness or sedation, difficulty breastfeeding, breathing difficulties, and decreased tone, in their baby. Nursing mothers who are ultra-rapid metabolizers may also experience overdose symptoms such as extreme sleepiness, confusion, or shallow breathing. Prescribers should closely monitor mother-infant pairs and notify treating pediatricians about the use of codeine during breastfeeding (see PRECAUTIONS – General - Ultra-Rapid Metabolizers of Codeine ).

Caution should be exercised when Phensedyl Dry Family Cough (Promethazine Hydrochloride) with codeine syrup is administered to a nursing woman.

Pediatric Use:

The combination of Phensedyl Dry Family Cough (Promethazine Hydrochloride) hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age, because the combination may cause fatal respiratory depression in this age population (see WARNINGS – Box Warning and Use In Pediatric Patients).

The combination of Phensedyl Dry Family Cough (Promethazine Hydrochloride) hydrochloride and codeine phosphate should be used with caution in pediatric patients 6 years and older (see Warnings-Use in Pediatric Patients ).

Geriatric Use:

Clinical studies of Phensedyl Dry Family Cough (Promethazine Hydrochloride) hydrochloride and codeine phosphate syrup did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

Sedating drugs may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of Phensedyl Dry Family Cough (Promethazine Hydrochloride) with codeine syrup and observed closely.

ADVERSE REACTIONS

Codeine:

Nervous System – CNS depression, particularly respiratory depression, and to a lesser extent circulatory depression; light-headedness, dizziness, sedation, euphoria, dysphoria, headache, transient hallucination, disorientation, visual disturbances, and convulsions.

Cardiovascular – Tachycardia, bradycardia, palpitation, faintness, syncope, orthostatic hypotension (common to narcotic analgesics).

Gastrointestinal – Nausea, vomiting, constipation, and biliary tract spasm. Patients with chronic ulcerative colitis may experience increased colonic motility; in patients with acute ulcerative colitis, toxic dilation has been reported.

Genitourinary – Oliguria, urinary retention; antidiuretic effect has been reported (common to narcotic analgesics).

Allergic – Infrequent pruritus, giant urticaria, angioneurotic edema, and laryngeal edema.

Other – Flushing of the face, sweating and pruritus (due to opiate-induced histamine release); weakness.

Phensedyl Dry Family Cough (Promethazine Hydrochloride):

Central Nervous System – Drowsiness is the most prominent CNS effect of this drug. Sedation, somnolence, blurred vision, dizziness; confusion, disorientation, and extrapyramidal symptoms such as oculogyric crisis, torticollis, and tongue protrusion; lassitude, tinnitus, incoordination, fatigue, euphoria, nervousness, diplopia, insomnia, tremors, convulsive seizures, excitation, catatonic-like states, hysteria. Hallucinations have also been reported.

Cardiovascular – Increased or decreased blood pressure, tachycardia, bradycardia, faintness.

Dermatologic – Dermatitis, photosensitivity, urticaria.

Hematologic – Leukopenia, thrombocytopenia, thrombocytopenic purpura, agranulocytosis.

Gastrointestinal – Dry mouth, nausea, vomiting, jaundice.

Respiratory – Asthma, nasal stuffiness, respiratory depression (potentially fatal) and apnea (potentially fatal). (See WARNINGS - Phensedyl Dry Family Cough (Promethazine Hydrochloride); Respiratory Depression.)

Other – Angioneurotic edema. Neuroleptic malignant syndrome (potentially fatal) has also been reported. (See WARNINGS - Phensedyl Dry Family Cough (Promethazine Hydrochloride); Neuroleptic Malignant Syndrome.)

Paradoxical Reactions – Hyperexcitability and abnormal movements have been reported in patients following a single administration of Phensedyl Dry Family Cough (Promethazine Hydrochloride) HCI. Consideration should be given to the discontinuation of Phensedyl Dry Family Cough (Promethazine Hydrochloride) HCl and to the use of other drugs if these reactions occur. Respiratory depression, nightmares, delirium, and agitated behavior have also been reported in some of these patients.

DRUG ABUSE AND DEPENDENCE

Controlled Substance:

Phensedyl Dry Family Cough with codeine syrup is a Schedule V Controlled Substance.

Abuse:

Codeine is known to be subject to abuse; however, the abuse potential of oral codeine appears to be quite low. Even parenteral codeine does not appear to offer the psychic effects sought by addicts to the same degree as heroin or morphine. However, codeine must be administered only under close supervision to patients with a history of drug abuse or dependence.

Dependence:

Psychological dependence, physical dependence, and tolerance are known to occur with codeine.

OVERDOSAGE

Codeine:

Serious overdose with codeine is characterized by respiratory depression, extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, and sometimes bradycardia and hypotension. The triad of coma, pinpoint pupils, and respiratory depression is strongly suggestive of opiate poisoning. In severe overdosage, particularly by the intravenous route, apnea, circulatory collapse, cardiac arrest, and death may occur. Phensedyl Dry Family Cough (Promethazine Hydrochloride) is additive to the depressant effects of codeine.

It is difficult to determine what constitutes a standard toxic or lethal dose. However, the lethal oral dose of codeine in an adult is reported to be in the range of 0.5 to 1.0 gram. Infants and children are believed to be relatively more sensitive to opiates on a body-weight basis. Elderly patients are also comparatively intolerant to opiates.

Phensedyl Dry Family Cough (Promethazine Hydrochloride):

Signs and symptoms of overdosage with Phensedyl Dry Family Cough (Promethazine Hydrochloride) HCl range from mild depression of the central nervous system and cardiovascular system to profound hypotension, respiratory depression, unconsciousness, and sudden death. Other reported reactions include hyperreflexia, hypertonia, ataxia, athetosis, and extensor-plantar reflexes (Babinski reflex).

Stimulation may be evident, especially in children and geriatric patients. Convulsions may rarely occur. A paradoxical-type reaction has been reported in children receiving single doses of 75 mg to 125 mg orally, characterized by hyperexcitability and nightmares.

Atropine-like signs and symptoms – dry mouth, fixed dilated pupils, flushing, as well as gastrointestinal symptoms may occur.

Treatment:

The treatment of overdosage with Phensedyl Dry Family Cough (Promethazine Hydrochloride) and codeine is essentially symptomatic and supportive. Only in cases of extreme overdosage or individual sensitivity do vital signs including respiration, pulse, blood pressure, temperature, and EKG need to be monitored. Activated charcoal orally or by lavage may be given, or sodium or magnesium sulfate orally as a cathartic. Attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and institution of assisted or controlled ventilation. The narcotic antagonist, naloxone hydrochloride, may be administered when significant respiratory depression occurs with Phensedyl Dry Family Cough (Promethazine Hydrochloride) and codeine; any depressant effects of Phensedyl Dry Family Cough (Promethazine Hydrochloride) are not reversed with naloxone. Diazepam may be used to control convulsions. Avoid analeptics, which may cause convulsions. Acidosis and electrolyte losses should be corrected. A rise in temperature or pulmonary complications may signal the need for institution of antibiotic therapy.

Severe hypotension usually responds to the administration of norepinephrine or phenylephrine. EPINEPHRINE SHOULD NOT BE USED, since its use in a patient with partial adrenergic blockade may further lower the blood pressure.

Limited experience with dialysis indicates that it is not helpful.

DOSAGE AND ADMINISTRATION

The combination of Phensedyl Dry Family Cough (Promethazine Hydrochloride) hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age, because the combination may cause fatal respiratory depression in this age population.

It is important that Phensedyl Dry Family Cough (Promethazine Hydrochloride) with codeine syrup is measured with an accurate measuring device (see PRECAUTIONS-Information For Patients ). A household teaspoon is not an accurate measuring device and could lead to overdosage, especially when half a teaspoon is to be measured. It is strongly recommended that an accurate measuring device be used. A pharmacist can provide an appropriate device and can provide instructions for measuring the correct dose.

The average effective dose for adults and children 12 years of age and over is: 1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 30 mL in 24 hours.

The average effective dose for children 6 years to under 12 years of age is 1/2 to 1 teaspoonful (2.5 mL to 5 mL) every 4 to 6 hours, not to exceed 30 mL in 24 hours.

HOW SUPPLIED

Phensedyl Dry Family Cough (Promethazine Hydrochloride) with Codeine Syrup, a clear purple syrup with odor of grape menthol, contains Phensedyl Dry Family Cough (Promethazine Hydrochloride) hydrochloride 6.25 mg/5 mL, codeine phosphate 10 mg/5 mL and alcohol 7 percent, and is available in 4 fluid ounce (118 mL), 8 fluid ounce (237 mL) and pint (473 mL).

Store at 20°-25°C (68°-77°F).

Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP.

Manufactured for:

QUALITEST PHARMACEUTICALS

Huntsville, AL 35811

8181652

R1/09-R4

Pseudoephedrine Hydrochloride:

• Congestac
• Phensedyl Dry Family Cough (Pseudoephedrine Hydrochloride) reviews

Active ingredients (in each caplet)...Purpose

Guaifenesin 400 mg...Expectorant

Phensedyl Dry Family Cough (Pseudoephedrine Hydrochloride) hydrochloride 60 mg...Nasal decongestant

Uses

For temporarily relief of nasal congestion due to a cold, hay fever, or other upper respiratory allergies (allergic rhinitis), and to help loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Uses

• temporarily relieves nasal congestion due to a cold, hay fever, or other upper respiratory allergies (allergic rhinitis).
• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Warnings

Do not exceed recommended dosage.

Do not use if you are taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for two weeks after stopping the MAOI. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.

A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.

Ask a doctor before use if you have

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• difficulty in urinating due to an enlarged prostate gland

Stop use and ask a doctor if

• you get nervous, dizzy, or sleepless
• symptoms do not improve within 7 days or are accompanied by fever

If pregnant or breast-feeding, ask a health professional before use.

Keep this and all drugs out of reach of children. In case of overdose, get medical help or contact a poison control center immediately.

Directions

• adults and children 12 years and older, 1 caplet every 4 to 6 hours, not more than 4 caplets in 24 hours
• children 6 to under 12 years, ½ caplet every 4 to 6 hours, not more than 2 caplets in 24 hours
• children under 6 years, consult a physician

Inactive ingredients

croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, and starch

Questions?

1-800-324-1880, 7:30am - 4:00pm Central, Mon.-Fri., or visit us at www.bfascher.com

Phensedyl Dry Family Cough