Phenylephrine is an alpha-1 adrenergic agonist sold in the U.S. under 4 brand and generic names, for fissure in ano, open-angle glaucoma and hemorrhoids. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Immphentiv (application NDA203826). Other phenylephrine products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Dilute before administration ( 2.1 ). Dosing for Perioperative Hypotension • Intravenous bolus administration: 50 mcg to 250 mcg ( 2.4 ) • Intravenous continuous infusion: 0.5 mcg/kg/minute to 1.4 mcg/kg/minute titrated to effect ( 2.4 ) Dosing for Patients with Vasodilatory Shock • Intravenous continuous infusion: 0.5 mcg/kg/minute to 6 mcg/kg/minute titrated to effect ( 2.5 ) 2.1 General Administration Instructions Phenylephrine hydrochloride must be diluted before administration as bolus intravenous infusion or continuous intravenous infusion. Inspect the solution for particulate matter and discoloration prior to administration. The diluted solution should not be held for more than 4 hours at room temperature or for more than 24 hours under refrigerated conditions. Discard any unused portion. During phenylephrine hydrochloride administration: Correct intravascular volume depletion. Correct acidosis. Acidosis may reduce the effectiveness of phenylephrine. 2.2 Preparing a 100 mcg/mL Solution of Bolus Intravenous Administration For bolus intravenous administration, withdraw 10 mg (1 mL of a 10 mg/mL concentration) of phenylephrine injection and dilute with 99 mL of 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP. This will yield a final concentration of 100 mcg/mL. Withdraw an appropriate dose from the 100 mcg/mL solution prior to bolus intravenous…
The following adverse reactions associated with the use of phenylephrine hydrochloride were identified in the literature. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure. Cardiac disorders: Bradycardia, AV block, ventricular extrasystoles, myocardial ischemia Gastrointestinal disorders: Nausea, vomiting General disorders and administrative site conditions: Chest pain, extravasation Immune system disorders: Sulfite sensitivity Nervous system disorders: Headache, nervousness, paresthesia, tremor Psychiatric disorders: Excitability Respiratory: Pulmonary edema, rales Skin and subcutaneous tissue disorders: Diaphoresis, pallor, piloerection, skin blanching, skin necrosis with extravasation Vascular disorders: Hypertensive crisis Most common adverse reactions: nausea and vomiting, headache, nervousness ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 70/100 | Prescription | Injectable | Generic | $9 | View → | |
| 2 | Not yet rated | Prescription | Injectable | Generic | $9 |
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| 44;455 | 325 mg / 2 mg / 5 mg | white | oval | — |
| A15 | 500 mg / 4 mg / 10 mg | white | round | — |
| 44;503 | 325 mg / 10 mg / 200 mg / 5 mg | yellow | oval | — |
| SUPE | 200 mg / 10 mg | white | oval | — |
| Advil;A;CR | 4 mg / 200 mg / 10 mg | gray | oval | — |
| Advil;A;CR |
A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Phenylephrine Hydrochloride Injectable Solution
cGMP deviations.
Wells Pharma of Houston LLC · Apr 1, 2026
Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophth…
Incorrect Product Formulation
Fagron Compounding Services · Nov 20, 2025
Phenylephrine HCI
CGMP Deviations
Park Avenue Compounding · Sep 17, 2025
Tropicamide-Proparacaine-Phenylephrine-Ketorolac
Sub-Potent Drug: Subpotent assay results during stability testing.
Imprimis NJOF, LLC · Jul 9, 2025
PHENYLephrine HCl in 0.9% Sodium Chloride
Lack of Assurance of Sterility: Leaking/damaged syringes.
Denver Solutions, LLC DBA Leiters Health · Mar 31, 2025
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
The use of phenylephrine hydrochloride is contraindicated in patients with: Hypersensitivity to it or any of its components Hypersensitivity to it or any of its components ( 4 )
Agonistic effects with monoamine oxidase inhibitors (MAOI), β-adrenergic blocking agents, α-2 adrenergic agonists, steroids, tricyclic antidepressants, norepinephrine transport inhibitors, ergot alkaloids, centrally-acting sympatholytic agents and atropine sulfate ( 7.1 ). Antagonistic effects on and by α-adrenergic blocking agents ( 7.2 ) 7.1 Agonists The pressor effect of phenylephrine hydrochloride is increased in patients receiving: Monoamine oxidase inhibitors (MAOI), such as selegiline. β-adrenergic blockers α-2 adrenergic agonists, such as clonidine Steroids Tricyclic antidepressants Norepinephrine transport inhibitors, such as atomoxetine Ergot alkaloids, such as methylergonovine maleate Centrally-acting sympatholytic agents, such as guanfacine or reserpine Atropine sulfate 7.2 Antagonists α-adrenergic blocking agents, including phenothiazines (e.g., chlorpromazine) and amiodarone block phenylephrine and are in turn blocked by phenylephrine.
| View → |
| 3 | Not yet rated | Prescription | Solution | Generic | $9 | View → |
| 4 | Not yet rated | Prescription | Solution | Generic | $9 | View → |
| 4 mg / 200 mg / 10 mg |
| gray |
| oval |
| — |
| Advil;A;CR | 4 mg / 200 mg / 10 mg | gray | oval | — |
|---|
| 44;502 | 325 mg / 5 mg | orange | oval | — |
|---|