Quick answers
- What is Promethazine hydrochloride and phenylephrine hydrochloride used for?
- The FDA-approved label (Promethazine Hydrochloride and Phenylephrine Hydrochloride, Amneal Pharmaceuticals LLC, October 30, 2024) says: “Promethazine hydrochloride and phenylephrine hydrochloride oral solution, USP is indicated for the temporary relief of upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Promethazine hydrochloride and phenylephrine hydrochloride have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Promethazine hydrochloride and phenylephrine hydrochloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Promethazine hydrochloride and phenylephrine hydrochloride been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Promethazine hydrochloride and phenylephrine hydrochloride?
- 2 companies list prescription products of Promethazine hydrochloride and phenylephrine hydrochloride in the FDA NDC Directory, including Genus Lifesciences Inc. and Amneal Pharmaceuticals LLC.
What Promethazine hydrochloride and phenylephrine hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Promethazine hydrochloride and phenylephrine hydrochloride oral solution, USP is indicated for the temporary relief of upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.
— FDA label: Promethazine Hydrochloride and Phenylephrine Hydrochloride, Amneal Pharmaceuticals LLC, effective October 30, 2024. 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.
The label quoted above has no boxed warning.
Forms and how it is given
| Dosage forms | Solution |
|---|---|
| Route | Oral |
| Prescription products | 2 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.
- Genus Lifesciences Inc.1 product
- Amneal Pharmaceuticals LLC1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (2)
- ANDA040654Pai Holdings · December 7, 2006
- ANDA040902Amneal Pharms · August 25, 2009
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) | 1248057 |
|---|---|
| SPL set ID of the quoted label | cf4ef7c0-2f4a-4b0f-9060-ad0b909d1ed4 |
| FDA labels (SPL) | 1 |
| FDA applications | 2 ANDA |
| Active ingredients (FDA) | PHENYLEPHRINE / PROMETHAZINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Promethazine Hydrochloride and Phenylephrine Hydrochloride, Amneal Pharmaceuticals LLC, effective October 30, 2024; 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 →