FDA label
What is promethazine and codeine used for?
The FDA-approved uses of promethazine 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 HCl and Codeine Phosphate Oral Solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold in patients 18 years of age and older.”
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Promethazine Hydrochloride and Codeine Phosphate, solution
Indications and Usage, quoted from the label by Cosette Pharmaceuticals, Inc. (ANDA200386). Cross-references to other label sections are left out.
Promethazine HCl and Codeine Phosphate Oral Solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold in patients 18 years of age and older.
Important Limitations of Use
- Not indicated for pediatric patients under 18 years of age [see Use in Specific Populations ].
- Contraindicated in pediatric patients under 12 years of age [see Contraindications, Use in Specific Populations ].
- Contraindicated in pediatric patients 12 to 18 years of age after tonsillectomy or adenoidectomy [see Contraindications, Use in Specific Populations ].
- Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions ], 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.
Source: DailyMed label, set id 3b02cda4-9b24-79c9-e063-6294a90af5b9, version 1, effective December 18, 2025. NDC 0713-0823, one of 5 listings for this product.
Questions
What is promethazine and codeine used for?
The FDA label says: “Promethazine HCl and Codeine Phosphate Oral Solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold in patients 18 years of age and older.”
What drug class is promethazine and codeine?
FDA lists promethazine and codeine in the Opioid Agonist and Phenothiazine 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 and Codeine
- Is Promethazine and Codeine a controlled substance?Schedule V
- Generic for Phenergan W/ CodeineFDA Orange Book
- Opioid Agonists listFDA drug class
- Phenothiazines listFDA drug class
- NDC 0713-0823Promethazine and Codeine NDC record
- NDC 17856-0065Promethazine and Codeine NDC record
- NDC 27808-065Promethazine and Codeine NDC record
- Schedule V drugs listDEA schedule