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Promethazine HCl and codeine phosphate oral solution exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient’s risk before prescribing and monitor closely for these behaviors and conditions. (5.1)
Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or when used in patients at higher risk. (5.2)
Accidental ingestion of promethazine HCl and codeine phosphate oral solution, especially by children, can result in a fatal overdose of codeine. (5.2)
Life-threatening respiratory depression and death have occurred in children who received codeine; most cases followed tonsillectomy and/or adenoidectomy, and many of the children had evidence of being an ultra-rapid metabolizer of codeine due to a CYP2D6 polymorphism. (5.3) Promethazine HCl and codeine phosphate oral solution is contraindicated in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy. (4) Avoid the use of promethazine HCl and codeine phosphate oral solution inadolescents 12 to 18 years of age who have other risk factors that may increase their sensitivity to the respiratory depressant effects of codeine.
Postmarketing cases of respiratory depression, including fatalities have been reported with use of promethazine in pediatric patients. Children may be particularly sensitive to the additive respiratory depressant effects when promethazine is combined with other respiratory depressants, including codeine. (5.4).
Ensure accuracy when prescribing, dispensing, and administering promethazine HCl and codeine phosphate oral solution. Dosing errors can result in accidental overdose and death. (2,1, 5.7)
The effects of concomitant use or discontinuation of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with codeine are complex, requiring careful consideration of the effects on the parent drug, codeine, and the active metabolite, morphine. Avoid the use of promethazine HCl and codeine phosphate oral solution in patients who are taking a CYP3A4 inhibitor, CYP3A4 inducer, or 2D6 inhibitor. (5.9, 7.1, 7.2, 7.3)
Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Avoid the use of promethazine HCl and codeine phosphate oral solution in patients taking benzodiazepines, other CNS depressants, or alcohol. (5.10, 7.4)
Promethazine HCl and codeine phosphate oral solution is not recommended for use in pregnant women. Prolonged use of promethazine HCl and codeine phosphate oral solution during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If promethazine HCl and codeine phosphate oral solution is used for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. (5.19, 8.1)

Description

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 [PROMETHAZINE HCl AND CODEINE PHOSPHATE ORAL SOLUTION enter drug name] safely and effectively.
See full prescribing information for PROMETHAZINE HCl AND CODEINE PHOSPHATE ORAL SOLUTION.
PROMETHAZINE HCl AND CODEINE PHOSPHATE oral solution, CV
Initial U.S. Approval: 1952

WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; ULTRA-RAPID METABOLISM OF CODEINE AND OTHER RISK FACTORS FOR LIFE-THREATENING RESPIRATORY DEPRESSION IN CHILDREN; PROMETHAZINE AND RESPIRATORY DEPRESSION IN CHILDREN; MEDICATION ERRORS; INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES; CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; NEONATAL OPIOID WITHDRAWAL SYNDROME

SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING.

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Promethazine HCl and codeine phosphate oral solution exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient’s risk before prescribing and monitor closely for these behaviors and conditions. (5.1)
Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or when used in patients at higher risk. (5.2)
Accidental ingestion of promethazine HCl and codeine phosphate oral solution, especially by children, can result in a fatal overdose of codeine. (5.2)
Life-threatening respiratory depression and death have occurred in children who received codeine; most cases followed tonsillectomy and/or adenoidectomy, and many of the children had evidence of being an ultra-rapid metabolizer of codeine due to a CYP2D6 polymorphism. (5.3) Promethazine HCl and codeine phosphate oral solution is contraindicated in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy. (4) Avoid the use of promethazine HCl and codeine phosphate oral solution inadolescents 12 to 18 years of age who have other risk factors that may increase their sensitivity to the respiratory depressant effects of codeine.
Postmarketing cases of respiratory depression, including fatalities have been reported with use of promethazine in pediatric patients. Children may be particularly sensitive to the additive respiratory depressant effects when promethazine is combined with other respiratory depressants, including codeine. (5.4).
Ensure accuracy when prescribing, dispensing, and administering promethazine HCl and codeine phosphate oral solution. Dosing errors can result in accidental overdose and death. (2,1, 5.7)
The effects of concomitant use or discontinuation of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with codeine are complex, requiring careful consideration of the effects on the parent drug, codeine, and the active metabolite, morphine. Avoid the use of promethazine HCl and codeine phosphate oral solution in patients who are taking a CYP3A4 inhibitor, CYP3A4 inducer, or 2D6 inhibitor. (5.9, 7.1, 7.2, 7.3)
Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Avoid the use of promethazine HCl and codeine phosphate oral solution in patients taking benzodiazepines, other CNS depressants, or alcohol. (5.10, 7.4)
Promethazine HCl and codeine phosphate oral solution is not recommended for use in pregnant women. Prolonged use of promethazine HCl and codeine phosphate oral solution during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If promethazine HCl and codeine phosphate oral solution is used for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. (5.19, 8.1)

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INDICATIONS AND USAGE

Promethazine HCl and codeine phosphate oral solution is a combination of codeine, an opioid agonist, and promethazine, a phenothiazine, indicated for the temporary relief of cough and upper respiratory symptoms associated with allergy or the common cold in patients 18 years of age and older. (1) (1)

Important Limitations of Use (1) (1)

Not indicated for pediatric patients under 18 years of age.
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve promethazine HCl and codeine phosphate oral solution for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made.

DOSAGE AND ADMINISTRATION

Adults 18 years of age and older: 5 mL every 4 to 6 hours as needed, not to exceed 6 doses (30 mL) in 24 hours. (2.2)
Measure promethazine HCl and codeine phosphate oral solution with an accurate milliliter measuring device. (2.1, 5.7)
Do not increase the dose or dosing frequency. (2.1)
Prescribe for the shortest duration consistent with treatment goals. (2.3)
Reevaluate patients with unresponsive cough in 5 days or sooner for possible underlying pathology. (2.3)
Reevaluate patient prior to refilling. (2.3)
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DOSAGE FORMS AND STRENGTHS

Oral solution: Each 5 mL contains codeine phosphate, 10 mg and promethazine hydrochloride 6.25 mg, in a flavored syrup base. (3) (3)

CONTRAINDICATIONS

Children younger than 12 years of age. (4)
Significant respiratory depression. (4)
Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment. (4)
Known or suspected gastrointestinal obstruction, including paralytic ileus. (4)
Concurrent use of monoamine oxidase inhibitor (MAOI) therapy or within the last 14 days. (4)
History of an idiosyncratic reaction to promethazine or to other phenothiazines. (4)
Hypersensitivity to codeine or other opiates, promethazine, or any of the inactive ingredients in promethazine HCl and codeine phosphate oral solution. (4)

WARNINGS AND PRECAUTIONS

See Boxed WARNINGS (5)

Life-threatening respiratory depression in patients with chronic pulmonary disease or in elderly, cachectic, or debilitated patients: Monitor closely, particularly during initiation of therapy. (5.6)
Activities requiring mental alertness: Avoid engaging in hazardous tasks requiring mental alertness such as driving or operating machinery. (5.8)
Risks of use in patients with head injury, impaired consciousness, increased intracranial pressure, or brain tumors: Avoid use. May increase intracranial pressure and obscure the clinical course of head injuries. (5.12)
Neuroleptic Malignant Syndrome: Monitor during therapy. (5.13)
Paradoxical Reactions: Monitor during therapy. (5.14)
Seizures in patients with seizure disorders: Monitor during therapy. (5.15)
Bone marrow depression: Use with caution in patients with bone marrow depression. (5.17)
Severe hypotension: Monitor during initiation of therapy. Avoid use in patients with circulatory shock. (5.18)
Adrenal insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. (5.20)
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ADVERSE REACTIONS

See Boxed WARNINGS

Life-threatening respiratory depression in patients with chronic pulmonary disease or in elderly, cachectic, or debilitated patients: Monitor closely, particularly during initiation of therapy. (5.6)
Activities requiring mental alertness: Avoid engaging in hazardous tasks requiring mental alertness such as driving or operating machinery. (5.8)
Risks of use in patients with head injury, impaired consciousness, increased intracranial pressure, or brain tumors: Avoid use. May increase intracranial pressure and obscure the clinical course of head injuries. (5.12)
Neuroleptic Malignant Syndrome: Monitor during therapy. (5.13)
Paradoxical Reactions: Monitor during therapy. (5.14)
Seizures in patients with seizure disorders: Monitor during therapy. (5.15)
Bone marrow depression: Use with caution in patients with bone marrow depression. (5.17)
Severe hypotension: Monitor during initiation of therapy. Avoid use in patients with circulatory shock. (5.18)
Adrenal insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. (5.20)

DRUG INTERACTIONS

Serotonergic Drugs: Concomitant use may result in serotonin syndrome. Discontinue if serotonin syndrome is suspected. (7.5)
Muscle Relaxants: Avoid concomitant use. (7.7)
Diuretics: Codeine may reduce the efficacy of diuretics. Monitor for reduced effect. (7.8)
Anticholinergic Drugs: Concurrent use may cause paralytic ileus. (5.11, 7.9)

USE IN SPECIFIC POPULATIONS

Pregnancy: Avoid use in pregnant women. May cause fetal harm. (8.1)
Lactation: Breastfeeding not recommended. (8.2)
Renal Impairment: Use with caution in patients with severe renal impairment. (8.6)
Hepatic Impairment: Use with caution in patients with severe hepatic impairment. (8.7)
5 WARNINGS AND PRECAUTIONS

5.1 Addiction, Abuse, and Misuse

Promethazine HCl and codeine phosphate oral solution contains codeine, a Schedule V controlled substance. As an opioid, promethazine HCl and codeine phosphate oral solution exposes users to the risks of addiction, abuse, and misuse [see DRUG ABUSE AND DEPENDENCE (9)], which can lead to overdose and death [see OVERDOSE (10)]. Reserve promethazine HCl and codeine phosphate oral solution for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made. Assess each patient’s risk prior to prescribing promethazine HCl and codeine phosphate oral solution, prescribe promethazine HCl and codeine phosphate oral solution for the shortest duration that is consistent with individual patient treatment goals, monitor all patients regularly for the development of addiction or abuse, and refill only after reevaluation of the need for continued treatment.

Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed promethazine HCl and codeine phosphate oral solution. Addiction can occur at recommended dosages and if the drug is misused or abused. Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression).

Opioids are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Consider these risks when prescribing or dispensing promethazine HCl and codeine phosphate oral solution. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on the proper disposal of unused drug [see PATIENT COUNSELING INFORMATION (17)]. Contact local state professional licensing board or state controlled substances authority for information on how to prevent and detect abuse or diversion of this product.

5.2 Life-Threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, including codeine, one of the active ingredients in promethazine HCl and codeine phosphate oral solution. Codeine produces dose-related respiratory depression by directly acting on the brain stem respiratory center that controls respiratory rhythm and may produce irregular and periodic breathing. Codeine is subject to variability in metabolism based upon CYP2D6 genotype, which can lead to an increased exposure to the active metabolite morphine [see WARNINGS AND PRECAUTIONS (5.3)]. Promethazine exerts a depressant effect on the respiratory center that is independent of and additive to that of other respiratory depressants, including codeine [see WARNINGS AND PRECAUTIONS (5.4)]. Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death. Management of respiratory depression includes discontinuation of promethazine HCl and codeine phosphate oral solution, close observation, supportive measures, and use of opioid antagonists (e.g. naloxone), depending on the patient’s clinical status [see OVERDOSAGE (10)]. Carbon dioxide (CO2) retention from opioid-induced respiratory depression can exacerbate the sedating effects of opioids.

While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of promethazine HCl and codeine phosphate oral solution, the risk is greatest during the initiation of therapy, when promethazine HCl and codeine phosphate oral solution is used concomitantly with other drugs that may cause respiratory depression [see WARNINGS AND PRECAUTIONS (5.10)], in patients with chronic pulmonary disease or decreased respiratory reserve, and in patients with altered pharmacokinetics or altered clearance (e.g. elderly, cachectic, or debilitated patients) [see WARNINGS AND PRECAUTIONS (5.6)].

To reduce the risk of respiratory depression, proper dosing of promethazine HCl and codeine phosphate oral solution is essential [see DOSAGE AND ADMINISTRATION (2.1), WARNINGS AND PRECAUTIONS (5.7)]. Monitor patients closely, especially within the first 24 to 72 hours of initiating therapy or when used in patients at higher risk.

Overdose of codeine in adults has been associated with fatal respiratory depression, and the use of codeine in children younger than 12 years of age has been associated with fatal respiratory depression when used as recommended [see WARNINGS AND PRECAUTIONS (5.3)]. Accidental ingestion of even one dose of promethazine HCl and codeine phosphate oral solution, especially by children, can result in respiratory depression and death.

5.3 Ultra-Rapid Metabolism of Codeine and Other Risk Factors for Life-Threatening Respiratory Depression in Children

Life-threatening respiratory depression and death have occurred in children who received codeine. Codeine is subject to variability in metabolism based upon CYP2D6 genotype (described below), which can lead to an increased exposure to the active metabolite morphine. Based upon post-marketing reports, children younger than 12 years old appear to be more susceptible to the respiratory depressant effects of codeine, particularly if there are risk factors for respiratory depression. For example, many reported cases of death occurred in the post-operative period following tonsillectomy and/or adenoidectomy, and many of the children had evidence of being ultra-rapid metabolizers of codeine. Furthermore, children with obstructive sleep apnea who are treated with codeine for post-tonsillectomy and/or adenoidectomy pain may be particularly sensitive to its respiratory depressant effect. Because of the risk of life-threatening respiratory depression and death:

Promethazine HCl and codeine phosphate oral solution is contraindicated in all children younger than 12 years of age [see CONTRAINDICATIONS (4)].
Promethazine HCl and codeine phosphate oral solution is contraindicated for post-operative management in pediatric patients younger than 18 years of age following tonsillectomy and/or adenoidectomy [see CONTRAINDICATIONS (4)].
Avoid the use of promethazine HCl and codeine phosphate oral solution in adolescents 12 to 18 years of age who have other risk factors that may increase their sensitivity to the respiratory depressant effects of codeine. Risk factors include conditions associated with hypoventilation, such as postoperative status, obstructive sleep apnea, obesity, severe pulmonary disease, neuromuscular disease, and concomitant use of other medications that cause respiratory depression. [see WARNINGS AND PRECAUTIONS (5.10), USE IN SPECIFIC POPULATIONS (8.4)]
Healthcare providers should choose the lowest effective dose for the shortest period of time and inform patients and caregivers about these risks and the signs of morphine overdose [see WARNINGS AND PRECAUTIONS (5.1), OVERDOSAGE (10)].

Lactation

At least one death was reported in a nursing infant who was exposed to high levels of morphine in breast milk because the mother was an ultra-rapid metabolizer of codeine. Breastfeeding is not recommended during treatment with promethazine HCl and codeine phosphate oral solution [see USE IN SPECIFIC POPULATIONS (8.2)].

CYP2D6 Genetic Variability: Ultra-Rapid Metabolizers

Some individuals may be ultra-rapid metabolizers because of a specific CYP2D6 genotype (e.g., gene duplications denoted as *1/*1xN or *1/*2xN). The prevalence of this CYP2D6 phenotype varies widely and has been estimated at 1 to 10% for Whites (European, North American), 3 to 4% for Blacks (African Americans), 1 to 2% for East Asians (Chinese, Japanese, Korean), and may be greater than 10% in certain ethnic groups (i.e., Oceanian, Northern African, Middle Eastern, Ashkenazi Jews, Puerto Rican). 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 have life-threatening or fatal respiratory depression or experience signs of overdose (such as extreme sleepiness, confusion, or shallow breathing) [see OVERDOSAGE (10)]. Therefore, individuals who are ultra-rapid metabolizers should not use promethazine HCl and codeine phosphate oral solution.

5.4 Promethazine and Respiratory Depression

Children

Postmarketing cases of respiratory depression, including fatalities, have been reported with use of promethazine in pediatric patients. Concomitant administration with other respiratory depressants may increase the risk of respiratory depression. Children may be particularly sensitive to the additive respiratory depressant effects when promethazine is combined with other respiratory depressants, including codeine. [see WARNINGS AND PRECAUTIONS (5.3, 5.5, 5.10)].

Excessively large dosages of antihistamines, including promethazine hydrochloride, in pediatric patients may cause sudden death [see OVERDOSAGE (10)].

Concomitant Conditions and Other Risk Factors

Avoid use of promethazine in patients at risk for respiratory depression. Risk factors include conditions associated with hypoventilation, such as postoperative status, obstructive sleep apnea, obesity, severe pulmonary disease, neuromuscular disease, and concomitant use of other medications that cause respiratory depression [see WARNINGS AND PRECAUTIONS (5.6,5.10)].

5.5 Risks with Use in Pediatric Populations

Children are particularly sensitive to the respiratory depressant effects of codeine [see WARNINGS AND PRECAUTIONS (5.2, 5.3)] and promethazine [see WARNINGS AND PRECAUTIONS (5.4)]. Because of the risk of life-threatening respiratory depression and death, promethazine HCl and codeine phosphate oral solution is contraindicated in children less than 12 years of age, and in pediatric patients younger than 18 years of age following tonsillectomy and/or adenoidectomy [see CONTRAINDICATIONS (4)].

Use of promethazine HCl and codeine phosphate oral solution in children also exposes them to the risks of addiction, abuse, and misuse [see DRUG ABUSE AND DEPENDENCE (9)], which can lead to overdose and death [see WARNINGS AND PRECAUTIONS (5.1)OVERDOSAGE (10)]. Because the benefits of symptomatic treatment of cough associated with allergies or the common cold do not outweigh the risks of use of codeine in pediatric patients, promethazine HCl and codeine phosphate oral solution is not indicated for use in patients younger than 18 years of age [see INDICATIONS (1), USE IN SPECIFIC POPULATIONS (8.4)].

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5.6 Risks with Use in Other At-Risk Populations

Unresponsive Cough

The dosage of promethazine HCl and codeine phosphate oral solution 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 [see DOSAGE AND ADMINISTRATION (2.3)].

Asthma and Other Pulmonary Disease

The use of promethazine HCl and codeine phosphate oral solution in patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment is contraindicated [see CONTRAINDICATIONS (4)].

Opioid analgesics and antitussives, including codeine, one of the active ingredients in promethazine HCl and codeine phosphate oral solution, should not be used in patients with acute febrile illness associated with productive cough or in patients with 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.

Promethazine HCl and codeine phosphate oral solution-treated patients with significant chronic obstructive pulmonary disease or cor pulmonale, and those with a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression are at increased risk of decreased respiratory drive including apnea, even at recommended dosages of promethazine HCl and codeine phosphate oral solution [see WARNINGS AND PRECAUTIONS (5.2)].

Elderly, Cachectic, or Debilitated Patients

Life-threatening respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients because they may have altered pharmacokinetics or altered clearance compared to younger, healthier patients [see WARNINGS AND PRECAUTIONS (5.2)].

Because of the risk of respiratory depression, avoid the use of opioid antitussives, including promethazine HCl and codeine phosphate oral solution in patients with compromised respiratory function, patients at risk of respiratory failure, and in elderly, cachectic, or debilitated patients. If promethazine HCl and codeine phosphate oral solution is prescribed, monitor such patients closely, particularly when initiating promethazine HCl and codeine phosphate oral solution and when promethazine HCl and codeine phosphate oral solution is given concomitantly with other drugs that depress respiration [see WARNINGS AND PRECAUTIONS (5.10)].

5.7 Risks of Accidental Overdose and Death due to Medication Errors

Dosing errors can result in accidental overdose and death. To reduce the risk of overdose and respiratory depression, ensure that the dose of promethazine HCl and codeine phosphate oral solution is communicated clearly and dispensed accurately [see DOSAGE AND ADMINISTRATION (2.1)].

Advise patients to always use an accurate milliliter measuring device when measuring and administering promethazine HCl and codeine phosphate oral solution. Inform patients that a household teaspoon is not an accurate measuring device and such use could lead to overdosage and serious adverse reactions [see OVERDOSAGE (10)]. For prescriptions where a measuring device is not provided, a pharmacist can provide an appropriate calibrated measuring device and can provide instructions for measuring the correct dose.

5.8 Activities Requiring Mental Alertness: Risks of Driving or Operating Machinery

Codeine and promethazine, two of the active ingredients in promethazine HCl and codeine phosphate oral solution, may produce marked drowsiness and impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Advise patients to avoid engaging in hazardous tasks requiring mental alertness and motor coordination after ingestion of promethazine HCl and codeine phosphate oral solution. Avoid concurrent use of promethazine HCl and codeine phosphate oral solution with alcohol or other central nervous system depressants because additional impairment of central nervous system performance may occur [see WARNINGS AND PRECAUTIONS (5.10)].Buy-hi-tech-syrup-promethazine codeine-Buy Hi Tech Promethazine Codeine - Buy Cough Syrup - buy-hi- 
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