FDA label
What is promethazine, phenylephrine and codeine used for?
The FDA-approved uses of promethazine, phenylephrine and codeine, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “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.”
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Promethazine, Phenylephrine, Codeine, syrup
Indications and Usage, quoted from the label by Amneal Pharmaceuticals LLC (ANDA200963). Cross-references to other label sections are left out.
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.
- Contraindicated in pediatric patients under 12 years of age.
- Contraindicated in pediatric patients 12 to 18 years of age after tonsillectomy or adenoidectomy.
- 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.
Source: DailyMed label, set id 5f23b254-872b-4e88-91be-710c3ea7687b, version 36, effective January 8, 2026. NDC 65162-694, one of 1 listing for this product.
Questions
What is promethazine, phenylephrine and codeine used for?
The FDA label says: “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.”
What drug class is promethazine, phenylephrine and codeine?
FDA lists promethazine, phenylephrine and codeine in the Opioid Agonist and Phenothiazine and alpha-1 Adrenergic Agonist established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
More on Promethazine, Phenylephrine and Codeine
- Is Promethazine, Phenylephrine and Codeine a controlled substance?Schedule V
- Generic for Phenergan Vc W/ CodeineFDA Orange Book
- Opioid Agonists listFDA drug class
- Phenothiazines listFDA drug class
- Alpha-1 Adrenergic Agonists listFDA drug class
- NDC 65162-694Promethazine, Phenylephrine and Codeine NDC record
- Schedule V drugs listDEA schedule