Quick answers
- What is Promethazine, phenylephrine, codeine used for?
- The FDA-approved label (Promethazine and Phenylephrine HCl, and Codeine Phosphate, Amneal Pharmaceuticals LLC, January 8, 2026) 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. Limitations of Use Not indicated for pediatric patients under 18 years of age […]. Contraindicated in pediatric patients under 12 years of age […]. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Promethazine, phenylephrine, codeine have a boxed warning?
- Yes. The FDA label for Promethazine and Phenylephrine HCl, and Codeine Phosphate has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Promethazine, phenylephrine, codeine?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Promethazine, phenylephrine, codeine been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Promethazine, phenylephrine, codeine?
- 1 company lists prescription products of Promethazine, phenylephrine, codeine in the FDA NDC Directory, including Amneal Pharmaceuticals LLC.
What Promethazine, phenylephrine, codeine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
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 […]. …
— FDA label: Promethazine and Phenylephrine HCl, and Codeine Phosphate, Amneal Pharmaceuticals LLC, effective January 8, 2026. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
Forms and how it is given
| Dosage forms | Syrup |
|---|---|
| Route | Oral |
| Prescription products | 1 in the FDA NDC Directory |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Amneal Pharmaceuticals LLC1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (1)
- ANDA200963Amneal Pharms · August 26, 2015
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 996757 |
|---|---|
| SPL set ID of the quoted label | 5f23b254-872b-4e88-91be-710c3ea7687b |
| FDA labels (SPL) | 1 |
| FDA applications | 1 ANDA |
| Active ingredients (FDA) | CODEINE / PHENYLEPHRINE / PROMETHAZINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Promethazine and Phenylephrine HCl, and Codeine Phosphate, Amneal Pharmaceuticals LLC, effective January 8, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →