Promethazine and Phenylephrine HCl, and Codeine Phosphate 6.25 mg/5mL; 5 mg/5mL; 10 mg/5mL Syrup, 118 mL
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Opioid Agonist class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Codeine is used to relieve pain. It is also used to relieve cough. Codeine belongs to a class of medications called opiate (narcotic) analgesics and to a class of medications called antitussives. When codeine is used to treat pain, it works by changing the way the brain and nervous system respond to pain. When codeine is used to reduce coughing, it works by decreasing the activity in the part of the brain that causes coughing. Codeine is also available in combination with acetaminophen and aspirin, and as an ingredient in many cough and cold medications. This monograph only includes informatio...
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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UNII XF417D3PSL
Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
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UNII PQ6CK8PD0R
Ascorbic acid, also known as vitamin C, is a white crystalline powder. It serves as an antioxidant to prevent degradation of other ingredients and may also function as a preservative in the formulation.
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UNII 7FLD91C86K
Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
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UNII PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
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UNII A2I8C7HI9T
Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
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UNII SB8ZUX40TY
Saccharin sodium is an artificial sweetener made from saccharin salt. It's added to medicines to improve taste, especially in liquid formulations for children or bitter drugs.
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UNII OJ245FE5EU
Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
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UNII 1Q73Q2JULR
Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
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UNII 4VON5FNS3C
Sodium metabisulfite is a preservative derived from sulfur compounds. It prevents microbial growth and oxidation in medicines, helping extend shelf life and maintain product stability.
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UNII C151H8M554
A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
11 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Promethazine and Phenylephrine HCl, and Codeine Phosphate 6.25 mg/5mL; 5 mg/5mL; 10 mg/5mLthis 65162-0694-86 | Amneal | 118 ml | — | AA | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 65162-0694-86 You're viewing this | 118 mL in 1 BOTTLE (65162-694-86) | 2013-11-01 | Active |
| 65162-0694-90 | 473 mL in 1 BOTTLE (65162-694-90) | 2013-11-01 | Active |
You're viewing the smallest of 2 pack sizes for this product.
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| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
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 Addiction, Abuse, and Misuse Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death.
Reserve Promethazine and Phenylephrine 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 and Phenylephrine HCl and Codeine Phosphate Oral Solution, prescribe Promethazine and Phenylephrine 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 addition or abuse, and refill only after reevaluation of the need for continued treatment [see Warnings and Precautions (5.1) ].
Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution. Monitor for respiratory depression, especially during initiation of Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution therapy or when used in patients at higher risk [see Warnings and Precautions (5.2) ]. Accidental Ingestion Accidental ingestion of even one dose of Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution, especially by children, can result in a fatal overdose of codeine [see Warnings and Precautions (5.2) ] .
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. Most of the reported cases occurred following tonsillectomy and/or adenoidectomy, and many of the children had evidence of being an ultra-rapid metabolizer of codeine due to a CYP2D6 polymorphism [see Warnings and Precautions (5.3) ] . Promethazine and Phenylephrine 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 [see Contraindications (4) ] .
Avoid the use of Promethazine and Phenylephrine 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. Promethazine and Respiratory Depression in Children 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 [see Warnings and Precautions (5.4) ] .
Risk of Medication Errors Ensure accuracy when prescribing, dispensing, and administering Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution. Dosing errors can result in accidental overdose and death. Always use an accurate milliliter measuring device when measuring and administering Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution [see Dosage and Administration (2.1) , Warnings and Precautions (5.7) ] .
Interactions with Drugs Affecting Cytochrome P450 Isoenzymes The effects of concomitant use or discontinuation of cytochrome P450 3A4 inducers, 3A4 i…
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution is indicated for the temporary relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold in patients 18 years of age and older. Limitations of Use Not indicated for pediatric patients under 18 years of age [see Use in Specific Populations (8.4) ] . Contraindicated in pediatric patients under 12 years of age [see Contraindications (4) , Use in Specific Populations (8.4) ] .
Contraindicated in pediatric patients 12 to 18 years of age after tonsillectomy or adenoidectomy [see Contraindications (4) , Use in Specific Populations (8.4) ] . Because of the risks of addiction, abuse, misuse, overdose and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1) ], reserve Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution for use in adult patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of cough.
Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution is a combination of codeine, an opioid agonist; promethazine, a phenothiazine; and phenylephrine, an alpha-1 adrenergic receptor agonist, indicated for the temporary relief of cough and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold in patients 18 years of age and older. ( 1 ) Limitations of Use Not indicated for pediatric patients under 18 years of age. (1) Because of the risks of addiction, abuse, misuse, overdose, and death which can occur at any dosage or duration and persist over the course of therapy, reserve Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution for use in adult patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of cough.
(1 , 5.1)
⏱️ Dosage and Administration ▾
2 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 and Phenylephrine 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 ) Do not rapidly reduce or abruptly discontinue in a physically-dependent patient. (2.3)
2.1Important Dosage and Administration Instructions Ensure accuracy when prescribing, dispensing, and administering Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution to avoid dosing errors due to confusion between mg and mL, and with other codeine and promethazine solutions of different concentrations, which could result in accidental overdose and death. Ensure the proper dose is communicated and dispensed. When writing prescriptions, include both the total dose in mg and the total dose in volume.
Instruct patients and caregivers on how to accurately measure and take or administer the correct dose of Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution. Administer Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution by the oral route only. Strongly advise patients and caregivers to always use a graduated oral syringe or measuring cup, with metric units of measurements (i.e., mL), to correctly measure the prescribed amount of medication.
Inform patients and caregivers that oral dosing devices may be obtained from their pharmacy and to never use household teaspoons or tablespoons to measure Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution. Do not overfill. Rinse the measuring device with water after each use.
Advise patients not to increase the dose or dosing frequency of Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution because serious adverse events such as respiratory depression may occur with overdosage [see Warnings and Precautions (5.1) , Overdosage (10) ] . The dosage of Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution should not be increased if cough fails to respond; an unresponsive cough should be reevaluated for possible underlying pathology [see Dosage and Administration (2.3) , Warnings and Precautions (5.6) ] .
2.2Recommended Dosage 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.
2.3Monitoring, Maintenance, and Discontinuation of Therapy Prescribe Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution for the shortest duration that is consistent with individual patient treatment goals [see Warnings and Precautions (5.1) ]. Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy [see Warnings and Precautions (5.2) ]. Reevaluate patients with unresponsive cough in 5 days or sooner for possible underlying pathology, such as foreign body or lower respiratory tract disease [see Warnings and Precautions (5.6) ] .
If a patient requires a refill, reevaluate the cause of the cough and assess the need for continued treatment with Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution, the relative incidence of adverse reactions, and the development of addiction, abuse, or misuse [see Warnings and Precautions (5.1) ] . Do not rapidly reduce or abruptly discontinue Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution in a physically-dependent patient [see Drug Abuse and Dependence (9.3) ] . When a patient who has been taking Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution regularly and may be physically dependent no longer requires therapy with Promethazine and Ph…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Oral solution: Each 5 mL contains codeine phosphate USP, 10 mg; promethazine hydrochloride USP, 6.25 mg; and phenylephrine hydrochloride USP, 5 mg and alcohol 7.15%, in a flavored syrup base [see Description (11) ] . Oral solution: Each 5 mL contains codeine phosphate USP, 10 mg; promethazine hydrochloride USP 6.25 mg; and phenylephrine hydrochloride USP 5 mg, in a flavored syrup base. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution is contraindicated for: All children younger than 12 years of age [see Warnings and Precautions ( 5.2 , 5.3 , 5.5 ), Use in Specific Populations (8.4) ] . Postoperative pain management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy [see Warnings and Precautions (5.2 , 5.3 )] . Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution is also contraindicated in patients with: Significant respiratory depression [see Warnings and Precautions (5.2) ] .
Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions (5.6) ] . Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions (5.11) ] . Narrow angle glaucoma, urinary retention, severe hypertension, severe coronary artery disease, or peripheral vascular insufficiency (ischemia may result with risk of gangrene or thrombosis of compromised vascular beds) [see Warnings and Precautions (5.13) ] .
A history of an idiosyncratic reaction to promethazine or to other phenothiazines [see Warnings and Precautions (5.15) ] . Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within 14 days [see Warnings and Precautions (5.17) , Drug Interactions (7.6) ] . Hypersensitivity to codeine, promethazine, phenylephrine, or any of the inactive ingredients in Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution [see Adverse Reactions (6) ] .
Persons known to be hypersensitive to certain other opioids may exhibit cross-reactivity to codeine. 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 ) Patients with narrow angle glaucoma, urinary retention, severe hypertension, severe coronary artery disease, or peripheral vascular insufficiency.
( 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, phenylephrine, or any of the inactive ingredients in Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution.
( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS 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 ) Cardiovascular and central nervous system effects : Use with caution in patients with cardiovascular disorders. ( 5.13 ) Neuroleptic Malignant Syndrome : Monitor during therapy.
( 5.14 ) Paradoxical Reactions : Monitor during therapy. ( 5.15 ) Seizures in patients with seizure disorders : Monitor during therapy. ( 5.16 ) Bone marrow depression : Use with caution in patients with bone marrow depression.
( 5.18 ) Severe hypotension : Monitor during initiation of therapy. Avoid use in patients with circulatory shock. ( 5.19 ) Adrenal insufficiency : If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid.
( 5.21 )
5.1Addiction, Abuse, and Misuse Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution contains codeine, a Schedule V controlled substance. As an opioid, Promethazine and Phenylephrine 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 Overdosage (10) ]. Reserve Promethazine and Phenylephrine 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 and Phenylephrine HCl and Codeine Phosphate Oral Solution, prescribe Promethazine and Phenylephrine 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 and Phenylephrine HCl and Codeine Phosphate Oral Solution.
Addiction can occur at recommended dosages and if the drug is misused or abused. The risk of opioid-related overdose or overdose-related death is increased with higher opioid doses, and this risk persists over the course of therapy. In post-marketing studies, addiction, abuse, misuse, and fatal and non-fatal opioid overdose were observed in patients with long-term opioid use [see Adverse Reactions (6) ] .
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 and Phenylephrine 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.
5.2Life-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 and Phenylephrine HCl and Codeine Phosphate…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following serious adverse reactions are described, or described in greater detail, in other sections: Addiction, abuse, and misuse [see Warnings and Precautions (5.1) , Drug Abuse and Dependence (9.3) ] Life-threatening respiratory depression [see Warnings and Precautions (5.2 , 5.3 , 5.4 , 5.5 , 5.6 ), Overdosage (10) ] Ultra-rapid metabolism of codeine and other risk factors for life-threatening respiratory depression in children [see Warnings and Precautions (5.3) ] Accidental overdose and death due to medication errors [see Warnings and Precautions (5.7) ] Decreased mental alertness with impaired mental and/or physical abilities [see Warnings and Precautions (5.8) ] Interactions with benzodiazepines and other CNS depressants [see Warnings and Precautions (5.10) ] Paralytic ileus, gastrointestinal adverse reactions [see Warnings and Precautions (5.11) ] Increased intracranial pressure [see Warnings and Precautions (5.12) ] Obscured clinical course in patients with head injuries [see Warnings and Precautions (5.12) ] Cardiovascular effects [see Warnings and Precautions (5.13) ] Neuroleptic Malignant Syndrome [see Warnings and Precautions (5.14) ] Paradoxical reactions, including dystonias [see Warnings and Precautions (5.15) ] Seizures [see Warnings and Precautions (5.16) ] Interactions with MAOI [see Warnings and Precautions (5.17) ] Bone marrow suppression [see Warnings and Precautions (5.18) ] Severe hypotension [see Warnings and Precautions (5.19) ] Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.20) ] Adrenal insufficiency [see Warnings and Precautions (5.21) ] The following adverse reactions have been identified during clinical studies, in the literature, or during post-approval use of codeine, promethazine, and/or phenylephrine.
Because these reactions may be reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The most common adverse reactions to Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution include: Sedation (somnolence, mental clouding, lethargy), impaired mental and physical performance, lightheadedness, dizziness, headache, dry mouth, nausea, vomiting, constipation, shortness of breath, sweating, tachycardia, arrhythmias including premature ventricular contractions, CNS stimulation including anxiety, restlessness, nervousness, tremor, and irritability.
Other reactions include: Anaphylaxis : Anaphylaxis has been reported with codeine, one of the ingredients in Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution. Body as a whole : Coma, death, fatigue, falling injuries, hyperactivity, hyperthermia, lethargy, weakness. Cardiovascular : Peripheral edema, atrial fibrillation, myocardial infarction, increased blood pressure, decreased blood pressure, tachycardia, chest pain, palpitation, syncope, orthostatic hypotension, prolonged QT interval, hot flush.
Central Nervous System : Ataxia, confusion, diplopia, facial dyskinesia, insomnia, migraine, increased intracranial pressure, seizure, tinnitus, tremor, vertigo. Dermatologic : Flushing, hyperhidrosis, photosensitivity, pruritus, rash, urticaria. Endocrine/Metabolic : Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs.
Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use. Cases of androgen deficiency have occurred with chronic use of opioids [see Clinical Pharmacology (12.2) ] . Gastrointestinal : Abdominal pain, bowel obstruction, decreased appetite, diarrhea, difficulty swallowing, dry mouth, GERD, indigestion, dysguesia, ischemic colitis, jaundice, pancreatitis, paralytic ileus, biliary tract spasm (spasm of the sphincter of Oddi).
Genitourinary : Urinary tract infection, ureteral spasm, spasm of vesi…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS No specific drug interaction studies have been conducted with Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution. 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 ) Antihypertensive drugs : Concomitant use may interfere with antihypertensive effects. ( 7.10 ) Ergot alkaloids, atropine sulfate, steroids, angiotensin, aldosterone, norepinephrine transporter inhibitors, and tricyclic antidepressants : Concomitant use may enhance the pressor response and increase the risk of hypertension.
( 7.11 ) Sympathomimetic Agents : Concomitant use may result in tachycardia, arrhythmias, serious hypertensive response and possible stroke. ( 7.12 )
7.1Inhibitors of CYP3A4 The concomitant use of Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution with CYP3A4 inhibitors, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g. ketoconazole), or protease inhibitors (e.g., ritonavir), may result in an increase in codeine plasma concentrations with subsequently greater metabolism by cytochrome CYP2D6, resulting in greater morphine levels, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression, particularly when an inhibitor is added after a stable dose of Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution is achieved [see Warnings and Precautions (5.9) ] .
After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, it may result in lower codeine levels, greater norcodeine levels, and less metabolism via CYP2D6 with resultant lower morphine levels [see Clinical Pharmacology (12.3) ] , resulting in decreased opioid efficacy or a withdrawal syndrome in patients who had developed physical dependence to codeine. Avoid the use of Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution while taking a CYP3A4 inhibitor. If concomitant use is necessary, monitor patients for respiratory depression and sedation at frequent intervals.
7.2CYP3A4 Inducers The concomitant use of Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution and CYP3A4 inducers, such as rifampin, carbamazepine, or phenytoin, can result in lower codeine levels, greater norcodeine levels, and less metabolism via 2D6 with resultant lower morphine levels [see Clinical Pharmacology ( 12.3) ] , resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence [see Warnings and Precautions (5.9) ] . After stopping a CYP3A4 inducer, as the effects of the inducer decline, codeine plasma concentrations may increase with subsequently greater metabolism by cytochrome CYP2D6, resulting in greater morphine levels [see Clinical Pharmacology (12.3) ] , which could increase or prolong both the therapeutic effects and adverse reactions, and may cause serious respiratory depression.
Avoid the use of Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution in patients who are taking CYP3A4 inducers. If concomitant use of a CYP3A4 inducer is necessary, follow the patient for reduced efficacy.
7.3Inhibitors of CYP2D6 Codeine is metabolized by CYP2D6 to form morphine. The concomitant use of Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution and CYP2D6 inhibitors, such as paroxetine, fluoxetine, bupropion, or quinidine, can increase the plasma concentration of codeine, but can decrease the plasma concentration of active metabolite morphine, which could result in reduced efficacy [see Clinical Pharmacology (12.3) ] . After stopping a CYP2D6 inhibitor, as the effects of the inhibitor decline, the codeine plasma concentration will decrea…
👥 Use in Specific Populations ▾
8 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 )
8.1Pregnancy Risk Summary Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution is not recommended for use in pregnant women, including during or immediately prior to labor. Prolonged use of opioids during pregnancy may cause neonatal opioid withdrawal syndrome [see Warnings and Precautions (5.20) , Clinical Considerations ] . There are no available data with Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution use in pregnant women to inform a drug-associated risk for adverse developmental outcomes.
Published studies with codeine have reported inconsistent findings and have important methodological limitations ( see Data ). There are reports of respiratory depression when codeine is used during labor and delivery (see Clinical Considerations ) . Reproductive toxicity studies have not been conducted with Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution; however, studies are available with individual active ingredients ( see Data ).
In animal reproduction studies, codeine administered by the oral route to pregnant rats during the period of organogenesis increased resorptions and decreased fetal weights at a dose approximately 25 times the maximum recommended human dose (MRHD) in the presence of maternal toxicity ( see Data ). For pregnant mice and rats that received promethazine at doses 0.2 and 3-6 times the MRHD, during various periods of gestation, there were findings of increased fetal resorptions and skeletal fragility, decreased pup weight, and developmental delays of pups ( see Data ).
In studies with normotensive pregnant rabbits, which received phenylephrine during the period of organogenesis or later, there were findings of increased fetal lethality, adverse placental effects, and possible teratogenic effects at subcutaneous doses approximately 0.8 times the MRHD on a mg/m 2 basis. Premature labor was also observed when treatment was initiated during the second trimester or later ( see Data ). Based on the animal data, advise pregnant women of the potential risk to a fetus.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Clinical Considerations Fetal/Neonatal Adverse Reactions Prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea and failure to gain weight. The onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn.
Observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly [see Warnings and Precautions (5.20) ] . Maternal use of phenylephrine can cause fetal tachycardia. Labor or Delivery Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates.
An opioid overdose reversal agent, such as naloxone or nalmefene, must be available for reversal of opioid-induced respiratory depression in the neonate. Opioids, including Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution, c…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution is not recommended for use in pregnant women, including during or immediately prior to labor. Prolonged use of opioids during pregnancy may cause neonatal opioid withdrawal syndrome [see Warnings and Precautions (5.20) , Clinical Considerations ] . There are no available data with Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution use in pregnant women to inform a drug-associated risk for adverse developmental outcomes.
Published studies with codeine have reported inconsistent findings and have important methodological limitations ( see Data ). There are reports of respiratory depression when codeine is used during labor and delivery (see Clinical Considerations ) . Reproductive toxicity studies have not been conducted with Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution; however, studies are available with individual active ingredients ( see Data ).
In animal reproduction studies, codeine administered by the oral route to pregnant rats during the period of organogenesis increased resorptions and decreased fetal weights at a dose approximately 25 times the maximum recommended human dose (MRHD) in the presence of maternal toxicity ( see Data ). For pregnant mice and rats that received promethazine at doses 0.2 and 3-6 times the MRHD, during various periods of gestation, there were findings of increased fetal resorptions and skeletal fragility, decreased pup weight, and developmental delays of pups ( see Data ).
In studies with normotensive pregnant rabbits, which received phenylephrine during the period of organogenesis or later, there were findings of increased fetal lethality, adverse placental effects, and possible teratogenic effects at subcutaneous doses approximately 0.8 times the MRHD on a mg/m 2 basis. Premature labor was also observed when treatment was initiated during the second trimester or later ( see Data ). Based on the animal data, advise pregnant women of the potential risk to a fetus.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Clinical Considerations Fetal/Neonatal Adverse Reactions Prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea and failure to gain weight. The onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn.
Observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly [see Warnings and Precautions (5.20) ] . Maternal use of phenylephrine can cause fetal tachycardia. Labor or Delivery Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates.
An opioid overdose reversal agent, such as naloxone or nalmefene, must be available for reversal of opioid-induced respiratory depression in the neonate. Opioids, including Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution, can prolong labor through actions which temporarily reduce the strength, duration, and frequency of uterine contractions. However, this effect is not consistent and may be offset by an increased rate of cervical dilation, which tends to shorten labor.
Monitor neonates exposed to opioids during labor for signs of excess sedation…
🧒 Pediatric Use ▾
8.4Pediatric Use Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution is not indicated for use in patients younger than 18 years of age because the benefits of symptomatic treatment of cough associated with allergies or the common cold do not outweigh the risks for use of codeine in these patients [see Indications (1) , Warnings and Precautions (5.5) ] . Life-threatening respiratory depression and death have occurred in children who received codeine [see Warnings and Precautions (5.2) ] . In most of the reported cases, these events followed tonsillectomy and/or adenoidectomy, and many of the children had evidence of being ultra-rapid metabolizers of codeine (i.e., multiple copies of the gene for cytochrome P450 isoenzyme 2D6 or high morphine concentrations).
Children with sleep apnea may be particularly sensitive to the respiratory depressant effects of codeine. Life-threatening respiratory depression and death have also occurred in children who received promethazine [see Warnings and Precautions (5.4) ] . Because of the risk of life-threatening respiratory depression and death: Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution is contraindicated for all children younger than 12 years of age [see Contraindications (4) ] .
Promethazine and Phenylephrine 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 and Phenylephrine 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 unless the benefits outweigh the risks.
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 (5.3 , 5.6 )].
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies have not been conducted with Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution in geriatric populations. Use caution when considering the use of Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution in patients 65 years of age or older. Elderly patients may have increased sensitivity to codeine; greater frequency of decreased hepatic, renal, or cardiac function; or concomitant disease or other drug therapy [see Warnings and Precautions (5.6) ] .
Respiratory depression is the chief risk for elderly patients treated with opioids, including Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution. Respiratory depression has occurred after large initial doses of opioids were administered to patients who were not opioid-tolerant or when opioids were co-administered with other agents that depress respiration [see Warnings and Precautions (5.6 , 5.10 )] . Codeine is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function.
Because elderly patients are more likely to have decreased renal function, monitor these patients closely for respiratory depression, sedation, and hypotension.
🆘 Overdosage ▾
10 OVERDOSAGE Clinical Presentation Codeine Acute overdose with codeine is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, partial or complete airway obstruction, atypical snoring, hypotension, hypoglycemia, circulatory collapse, cardiac arrest, and death. Toxic leukoencephalopathy has been reported after opioid overdose and can present hours, days, or weeks after apparent recovery from the initial intoxication.
Codeine may cause miosis, even in total darkness. Pinpoint pupils are a sign of opioid overdose but are not pathognomonic (e.g., pontine lesions of hemorrhagic or ischemic origin may produce similar findings). Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations [see Clinical Pharmacology (12.2) ] .
Promethazine Signs and symptoms of overdosage with promethazine 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 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, tachycardia, hallucinations, gastrointestinal symptoms, convulsions, urinary retention, cardiac arrhythmias and coma) may be observed.
Impaired secretion from sweat glands following toxic doses of drugs with anticholinergic side effects may predispose to hyperthermia. Phenylephrine Signs and symptoms of overdosage with phenylephrine include headache, vomiting, hypertension, reflex bradycardia, cardiac arrhythmias including ventricular premature beats and ventricular tachycardia, convulsions, and cerebral hemorrhage. Overdosage may also be associated with a sensation of fullness in the head and tingling of the extremities.
Headache may be a symptom of hypertension. Bradycardia may be seen early in phenylephrine overdosage through stimulation of baroreceptors. Treatment of Overdose Treatment of overdosage is driven by the overall clinical presentation, and consists of discontinuation of Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution together with institution of appropriate therapy.
Give primary attention to the reestablishment of adequate respiratory exchange through provision of a patent and protected airway and the institution of assisted or controlled ventilation. Employ other supportive measures (including oxygen and vasopressors) in the management of circulatory shock and pulmonary edema as indicated. Cardiac arrest or arrhythmias will require advanced life-support techniques.
Gastric emptying may be useful in removing unabsorbed drug. For clinically significant respiratory or circulatory depression secondary to codeine overdose, administer an opioid overdose reversal agent such as naloxone or nalmefene. An opioid overdose reversal agent should not be administered in the absence of clinically significant respiratory depression.
Because the duration of opioid reversal is expected to be less than the duration of action of codeine in Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution, carefully monitor the patient until spontaneous respiration is reliably re-established. If the response to an opioid overdose reversal agent is suboptimal or only brief in nature, administer additional reversal agent as directed by the product’s prescribing information. The respiratory depressant effects of promethazine are not reversed by op…
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Codeine Codeine is an opioid agonist relatively selective for the mu-opioid receptor, but with a much weaker affinity than morphine. The analgesic and antitussive properties of codeine have been speculated to come from its conversion to morphine. The precise mechanism of action of codeine and other opiates is not known; however, codeine is believed to act centrally on the cough center.
In excessive doses, codeine will depress respiration. Promethazine Promethazine is a phenothiazine derivative, which differs structurally from the antipsychotic phenothiazines by the presence of a branched side chain and no ring substitution. Promethazine possesses antihistamine (H 1 receptor antagonist), antiemetic, sedative, and anticholinergic effects.
It prevents released histamine from dilating capillaries and causing edema of the respiratory mucosa. Phenylephrine Phenylephrine is a sympathomimetic amine that exerts a decongestant action on the nasal mucosa via alpha adrenergic receptor activity. It has the potential for excitatory side effects.
12.2Pharmacodynamics Codeine Effects on the Central Nervous System Codeine produces respiratory depression by direct action on brain stem respiratory centers. The respiratory depression involves a reduction in the responsiveness of the brain stem respiratory centers to both increases in carbon dioxide tension and to electrical stimulation. Codeine causes miosis, even in total darkness.
Pinpoint pupils are a sign of opioid overdose but are not pathognomonic (e.g., pontine lesions of hemorrhagic or ischemic origins may produce similar findings). Marked mydriasis rather than miosis may be seen due to hypoxia in overdose situations. Effects on the Gastrointestinal Tract and Other Smooth Muscle Codeine causes a reduction in motility associated with an increase in smooth muscle tone in the antrum of the stomach and duodenum.
Digestion of food in the small intestine is delayed and propulsive contractions are decreased. Propulsive peristaltic waves in the colon are decreased, while tone may be increased to the point of spasm resulting in constipation. Other opioid-induced effects may include a reduction in biliary and pancreatic secretions, spasm of sphincter of Oddi, transient elevations in serum amylase, and opioid-induced esophageal dysfunction (OIED).
Effects on the Cardiovascular System Codeine produces peripheral vasodilation which may result in orthostatic hypotension or syncope. Manifestations of histamine release and/or peripheral vasodilation may include pruritus, flushing, red eyes and sweating and/or orthostatic hypotension. Effects on the Endocrine System Opioids inhibit the secretion of adrenocorticotropic hormone (ACTH), cortisol, and luteinizing hormone (LH) in humans [see Adverse Reactions (6) ] .
They also stimulate prolactin, growth hormone (GH) secretion, and pancreatic secretion of insulin and glucagon. Chronic use of opioids may influence the hypothalamic-pituitary-gonadal axis, leading to androgen deficiency that may manifest as low libido, impotence, erectile dysfunction, amenorrhea, or infertility. The causal role of opioids in the clinical syndrome of hypogonadism is unknown because the various medical, physical, lifestyle, and psychological stressors that may influence gonadal hormone levels have not been adequately controlled for in studies conducted to date [see Adverse Reactions (6) ] .
Effects on the Immune System Opioids have been shown to have a variety of effects on components of the immune system in in vitro and animal models. The clinical significance of these findings is unknown. Overall, the effects of opioids appear to be modestly immunosuppressive.
Concentration–Adverse Reaction Relationships There is a relationship between increasing codeine plasma concentration and increasing frequency of dose-related opioid adverse reactions such as nausea, vomiting, CNS effects, and respiratory depression. In opioid-tolerant patie…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Codeine Codeine is an opioid agonist relatively selective for the mu-opioid receptor, but with a much weaker affinity than morphine. The analgesic and antitussive properties of codeine have been speculated to come from its conversion to morphine. The precise mechanism of action of codeine and other opiates is not known; however, codeine is believed to act centrally on the cough center.
In excessive doses, codeine will depress respiration. Promethazine Promethazine is a phenothiazine derivative, which differs structurally from the antipsychotic phenothiazines by the presence of a branched side chain and no ring substitution. Promethazine possesses antihistamine (H 1 receptor antagonist), antiemetic, sedative, and anticholinergic effects.
It prevents released histamine from dilating capillaries and causing edema of the respiratory mucosa. Phenylephrine Phenylephrine is a sympathomimetic amine that exerts a decongestant action on the nasal mucosa via alpha adrenergic receptor activity. It has the potential for excitatory side effects.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Each 5 mL of clear colorless to pale yellow, citrus-flavored oral solution contains promethazine hydrochloride USP, 6.25 mg ; phenylephrine hydrochloride USP, 5 mg ; codeine phosphate USP, 10 mg ; and alcohol 7.15% v/v and is available as: 4 fluid ounce (118 mL) bottles: NDC 65162-694-86 16 fluid ounce (473 mL) bottles: NDC 65162-694-90 Store at 20° to 25° C (68° to 77° F) [see USP Controlled Room Temperature]. Protect from light. Keep bottles tightly closed.
Dispense in tight, light-resistant container as defined in USP.
📋 Description ▾
11 DESCRIPTION Promethazine and phenylephrine HCl and codeine phosphate oral solution, USP contains codeine USP, an opioid agonist; promethazine, a phenothiazine; and phenylephrine, an alpha-1 adrenergic receptor agonist. Each 5 mL of promethazine and phenylephrine HCl and codeine phosphate oral solution, USP contains 10 mg of codeine phosphate, USP, 6.25 mg of promethazine hydrochloride, USP and 5 mg of phenylephrine hydrochloride, USP for oral administration. Promethazine and phenylephrine HCl and codeine phosphate oral solution, USP contains Alcohol 7.15% v/v.
Promethazine and phenylephrine HCl and codeine phosphate oral solution, USP also contains the following inactive ingredients: anhydrous citric acid, ascorbic acid, edetate disodium, glycerin, methylparaben, natural & artificial citrus flavor FN-7176, purified water, saccharin sodium, sodium benzoate, sodium metabisulfite, sodium citrate, and sucrose. Codeine Phosphate, USP The chemical name for codeine phosphate, USP is 7,8-Didehydro-4, 5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate. Codeine, USP is one of the naturally occurring phenanthrene alkaloids of opium derived from the opium poppy, it is classified pharmacologically as a narcotic analgesic.
The phosphate salt of codeine, USP occurs as white, needle-shaped crystals or white crystalline powder. Codeine phosphate, USP is freely soluble in water and slightly soluble in alcohol. The molecular weight is 406.37.
Its molecular formula is C 18 H 21 NO 3 •H 3 PO 4 • 1/2 H 2 O, and it has the following chemical structure. Promethazine Hydrochloride, USP The chemical name for promethazine hydrochloride USP, a phenothiazine derivative, is (±)-10-[2-(Dimethylamino)propyl] phenothiazine monohydrochloride. Promethazine hydrochloride, USP occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air.
It is soluble in water and freely soluble in alcohol. The molecular weight is 320.88. Its molecular formula is C 17 H 20 N 2 S • HCl, and it has the following chemical structure.
Phenylephrine Hydrochloride, USP The chemical name for phenylephrine hydrochloride USP, a sympathomimetic amine salt, is (-)- m -hydroxy-α-[(methyl-amino)methyl] benzyl alcohol hydrochloride. Phenylephrine hydrochloride, USP occurs as white or nearly white crystals, having a bitter taste. It is freely soluble in water and alcohol.
Phenylephrine hydrochloride, USP is subject to oxidation and must be protected from light and air. The molecular weight is 203.67. Its molecular formula is C 9 H 13 NO 2 • HCl, and it has the following chemical structure.
10 11 12
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Medication Guide ). Addiction, Abuse, and Misuse Inform patients that the use of Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose and death [see Warnings and Precautions (5.1) ]. Instruct patients not to share Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution with others and to take steps to protect Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution from theft or misuse.
Important Administration Instructions Instruct patients how to properly take Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution. Advise patients to measure Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution with an accurate milliliter measuring device. Patients should be informed that a household teaspoon is not an accurate measuring device and could lead to overdosage.
Advise patients to ask their pharmacist to recommend an appropriate measuring device and for instructions for measuring the correct dose [see Dosage and Administration (2) , Warnings and Precautions (5.7) ] . Instruct patients and caregivers on how to accurately measure and take or administer the correct dose of Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution. Strongly advise patients and caregivers to always use a graduated oral dosing syringe/measuring cup with metric units of measurements (i.e., mL) to correctly measure the prescribed amount of medication.
Inform patients and caregivers that oral dosing devices may be obtained from their pharmacy and to never use household teaspoons or tablespoons to measure Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution [see Dosage and Administration (2) ] . Advise patients and caregivers not to adjust the dose of Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution without consulting with a physician or other healthcare professional. Life-Threatening Respiratory Depression Inform patients of the risk of life-threatening respiratory depression, including information that the risk is greatest when starting Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution and that it can occur even at recommended dosages [see Warnings and Precautions (5.2) ] .
Advise patients how to recognize respiratory depression and to seek medical attention if breathing difficulties develop. Accidental Ingestion Inform patients that accidental ingestion, especially by children, may result in respiratory depression or death [see Warnings and Precautions (5.2) ] . Instruct patients to take steps to store Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution securely and to properly dispose of unused Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution in accordance with the local state guidelines and/or regulations.
Ultra-Rapid Metabolism of Codeine and Other Risk Factors for Life-Threatening Respiratory Depression in Children Advise caregivers that Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution is not indicated for pediatric patients under 18 years of age, and is contraindicated in all children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy. Medication Errors Strongly advise patients and caregivers to always use a graduated oral syringe or measuring cup, with metric units of measurements (i.e., mL), to correctly measure the prescribed amount of medication.
Inform patients and caregivers that oral dosing devices may be obtained from their pharmacy and to never use household teaspoons or tablespoons to measure Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution [see Warnings and Precautions (5.1) ]. Activities Requiring Mental Alertness Advise patients to avoid…
💬 Medication Guide ▾
MEDICATION GUIDE Promethazine (proe meth’ a zeen) and Phenylephrine Hydrochloride (fen” il ef’ rin hye” droe klor’ ide) and Codeine Phosphate (koe’ deen fos’ fate) Oral Solution, USP C-V What is the most important information I should know about Promethazine and Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution? Promethazine and Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution is not for children under 18 years of age. Promethazine and Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution can cause serious side effects, including: Addiction, abuse and misuse.
Taking Promethazine and Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution or other medicines that contain an opioid can cause addiction, abuse, and misuse, which can lead to overdose and death. This can happen even if you take Promethazine and Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution exactly as prescribed by your healthcare provider. Your risk of addiction, abuse, and misuse is increased if you or a family member has a history of drug or alcohol abuse or addiction, or mental health problems.
Do not share your Promethazine and Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution with other people. Keep Promethazine and Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution in a safe place away from children. Life-threatening breathing problems (respiratory depression) .
Promethazine and Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution can cause breathing problems (respiratory depression) that can happen at any time during treatment and can lead to death. Your risk of breathing problems is greatest when you first start taking Promethazine and Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution, are taking other medicines that can cause breathing problems, have certain lung problems, are elderly or have certain other health problems. Children are at higher risk for respiratory depression.
Breathing problems can happen even if you take Promethazine and Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution exactly as prescribed by your healthcare provider. Call your healthcare provider or get emergency medical help right away if anyone taking Promethazine and Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution, or your breastfeeding baby, has any of the symptoms below: increased sleepiness confusion difficulty breathing shallow breathing limpness Keep Promethazine and Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution in a safe place away from children.
Accidental use of even 1 dose of Promethazine and Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution, especially by a child, is a medical emergency and can cause breathing problems (respiratory depression) which can lead to death. If a child accidentally takes Promethazine and Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution, get emergency help right away. Overdose and death due to medicine dosing errors.
Overdose and death can happen if you measure the wrong dose of Promethazine and Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution. Always use an accurate milliliter (mL) measuring device to measure the correct amount of Promethazine and Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution. Do not use a household teaspoon to measure your medicine.
You may accidentally take too much. You can ask your pharmacist for the measuring device you should use and how to measure the correct dose. Breathing problems (respiratory depression) that can lead to death and opioid withdrawal can happen if you start taking or stop taking other medicines while taking Promethazine and Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution, including: certain antibiotics certain medicines to treat a fungal infection certain medicines to treat Human Immunodeficiency Virus (HIV)-1 infection, Acquired Immune Deficiency Syndrome (AIDS), o…