Phenylephrine Hydrochloride
Injection · Intravenous, Ophthalmic, Oral
Uses
Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10%, is indicated to dilate the pupil. Phenylephrine Hydrochloride Ophthalmic Solution is an alpha-1 adrenergic receptor agonist indicated to dilate the pupil ( 1 )
Dosage and administration
For patients 1 year of age and older : ( 2.1 ) Apply one drop of Phenylephrine Hydrochloride Ophthalmic Solution (2.5% or 10% strength) to conjunctival fornix at 3 to 5 minute intervals up to a maximum of 3 drops per eye. To obtain a greater degree of mydriasis, use 10% strength For pediatric patients less than 1 year of age : ( 2.2 ) Instill one drop of 2.5% strength to conjunctival fornix at 3 to 5 minute intervals up to a maximum of 3 drops per eye 2.1 General Dosing Recommendations In patients 1 year of age or greater, apply one drop of either phenylephrine hydrochloride ophthalmic solution 2.5% or 10% every 3 to 5 minutes to the conjunctival fornix as required up to a maximum of 3 drops per eye per day. In order to obtain a greater degree of mydriasis, phenylephrine hydrochloride ophthalmic solution 10% may be needed. 2.2 Dosing in Pediatric Patients Less Than 1 Year of Age In pediatric patients less than 1 year of age, one drop of phenylephrine hydrochloride ophthalmic solution 2.5% should be instilled at 3 to 5 minute intervals up to a maximum of 3 drops per eye.
Dosage forms and strengths
Phenylephrine hydrochloride ophthalmic solution, USP 2.5% is a clear, colorless to yellow, sterile topical ophthalmic solution containing phenylephrine hydrochloride 2.5%: each mL contains 25 mg of phenylephrine hydrochloride. Phenylephrine hydrochloride ophthalmic solution, USP 10% is a clear, colorless to yellow, sterile topical ophthalmic solution containing phenylephrine hydrochloride 10%.: each mL contains 100 mg of phenylephrine hydrochloride. Ophthalmic solution (sterile): ( 3 ) 25 mg of phenylephrine hydrochloride in one mL of solution (2.5%) 100 mg of phenylephrine hydrochloride in one mL of solution (10%)
Contraindications
The 10% strength is contraindicated in: Patients with hypertension, or thyrotoxicosis ( 4.1 ) Pediatric patients less than 1 year of age due to increased risk of systemic toxicity ( 4.2 ) 4.1 Cardiac and Endocrine Disease Phenylephrine hydrochloride ophthalmic solution 10% is contraindicated in patients with hypertension or thyrotoxicosis. Phenylephrine hydrochloride ophthalmic solution 2.5% should be used in these patients. 4.2 Pediatric Patients Less Than 1 Year of Age Phenylephrine hydrochloride ophthalmic solution 10% is contraindicated in pediatric patients less than 1 year of age due to the increased risk of systemic toxicity. Phenylephrine hydrochloride ophthalmic solution 2.5% should be used in these patients [See Dosage and Administration ( 2.2 )] .
Warnings and precautions
Not for injection : Topical ophthalmic use only ( 5.1 ) Serious cardiovascular reactions with 10% strength : Reactions have included ventricular arrhythmias and some have been fatal. Monitor blood pressure in patients with cardiovascular disease ( 5.2 ). Significant elevations in blood pressure : Caution in pediatric patients less than 5 years of age, and in patients with cardiovascular disease or hyperthyroidism. In patients at high risk, monitor blood pressure post treatment ( 5.3 ). Rebound miosis : Reported one day after instillation ( 5.4 ) 5.1 Topical Ophthalmic Use Only Phenylephrine hydrochloride ophthalmic solution 2.5% and 10% is not indicated for injection. 5.2 Cardiovascular Reactions There have been reports of serious cardiovascular reactions, including ventricular arrhythmias and myocardial infarctions, in patients using phenylephrine 10%. These episodes, some fatal, have usually occurred in patients with pre-existing cardiovascular diseases. Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% should be used in these patients. 5.3 Elevation of Blood Pressure A significant elevation in blood pressure is not common but has been reported following conjunctival instillation of recommended doses of phenylephrine 10%. The risk is less with phenylephrine 2.5%. Caution should be exercised with the use of phenylephrine 10% in pediatric patients less than 5 years of age and patients with hyperthyroidism, or cardiovascular disease. The post-treatment blood pressure of patients with cardiac and endocrine diseases and any patients who develop symptoms should be carefully monitored. 5.4 Rebound Miosis Rebound miosis has been reported one day after receiving phenylephrine hydrochloride ophthalmic solution, and re-instillation of the drug produced a lesser mydriatic effect.
Side effects
The following serious adverse reactions are described below and elsewhere in the labeling: Cardiovascular Effects [ See Warnings and Precautions ( 5.2 )] Elevation in Blood Pressure [ See Warnings and Precautions ( 5.3 )] The following adverse reactions have been identified following use of phenylephrine hydrochloride ophthalmic solution. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Ocular adverse reactions include eye pain and stinging on instillation, temporary blurred vision, and photophobia ( 6.1 ) Cardiovascular adverse reactions include increase in blood pressure, syncope, myocardial infarction, tachycardia, arrhythmia and subarachnoid hemorrhage ( 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact Alcon Laboratories at 1-800- 757-9195 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Ocular Adverse Reactions Eye pain and stinging on instillation, temporary blurred vision and photophobia, and conjunctival sensitization may occur. 6.2 Systemic Adverse Reactions A marked increase in blood pressure has been reported particularly, but not limited to low weight premature neonates, infants and hypertensive patients. Cardiovascular effects which have been seen primarily in hypertensive patients following topical ocular use of phenylephrine hydrochloride ophthalmic solution 10% include marked increase in blood pressure, syncope, myocardial infarction, tachycardia, arrhythmia and subarachnoid hemorrhage [ See Warnings and Precautions ( 5.2 and 5.3 )].
Drug interactions
Atropine-like drugs : May exaggerate the adrenergic pressor response ( 7.1 ) Potent inhalation anesthetic agents : May potentiate cardiovascular depressant effects ( 7.1 ) 7.1 Agents That May Exaggerate Pressor Responses Concomitant use of phenylephrine and atropine may enhance the pressor effects and induce tachycardia in some patients. Phenylephrine may potentiate the cardiovascular depressant effects of some inhalation anesthetic agents.
Use in specific populations
8.1 Pregnancy Animal reproduction studies have not been conducted with topical phenylephrine. It is also not known whether phenylephrine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Phenylephrine hydrochloride should be given to a pregnant woman only if clearly needed. 8.3 Nursing Mothers It is not known whether this drug is excreted in human breast milk. Because many drugs are excreted in human milk, caution should be exercised when phenylephrine hydrochloride ophthalmic solution 2.5% and 10% is administered to a nursing woman. 8.4 Pediatric Use Phenylephrine hydrochloride ophthalmic solution 10% is contraindicated in pediatric patients less than 1 year of age [ See Contraindications ( 4.2 ) ]. 8.5 Geriatric Use No overall differences in safety and effectiveness have been observed between elderly and younger adult patients.
Pregnancy
8.1 Pregnancy Animal reproduction studies have not been conducted with topical phenylephrine. It is also not known whether phenylephrine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Phenylephrine hydrochloride should be given to a pregnant woman only if clearly needed.
Pediatric use
8.4 Pediatric Use Phenylephrine hydrochloride ophthalmic solution 10% is contraindicated in pediatric patients less than 1 year of age [ See Contraindications ( 4.2 ) ].
Geriatric use
8.5 Geriatric Use No overall differences in safety and effectiveness have been observed between elderly and younger adult patients.
Overdosage
Overdosage of phenylephrine may cause a rapid rise in blood pressure. It may also cause headache, anxiety, nausea, and vomiting, and ventricular arrhythmias. Prompt injection of a rapidly acting alpha-adrenergic blocking agent such as phentolamine has been recommended.
Description
Phenylephrine Hydrochloride Ophthalmic Solution, USP is a sterile, clear, colorless to yellow, topical α-adrenergic agonist for ophthalmic use. The active ingredient is represented by the chemical structure Chemical Name: (R)-3-hydroxy-α[(methylamino)methyl]benzenemethanol hydrochloride. Molecular Formula: C 9 H 13 NO 2 .HCl Molecular Weight: 203.67 g/mol Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% contains: ACTIVE: Phenylephrine Hydrochloride 25 mg (2.5%); INACTIVES: Sodium Phosphate Monobasic, Sodium Phosphate Dibasic, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.5). The solution has a tonicity of 340 mOsm/kg; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%). Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% contains: ACTIVE: Phenylephrine Hydrochloride 100 mg (10%); INACTIVES: Sodium Phosphate Monobasic, Sodium Phosphate Dibasic, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.5). The solution has a tonicity of 985 mOsm/kg; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%). Chemical Structure
Mechanism of action
12.1 Mechanism of Action Phenylephrine hydrochloride is an α-1 adrenergic agonist drug that is used in ophthalmology mainly for its mydriatic effect. After topical application to the conjunctiva, phenylephrine acts directly on α-adrenergic receptors in the eye, producing contraction of the dilator muscle of the pupil and constriction of the arterioles in the conjunctiva.
How supplied
Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% is supplied as a sterile, aqueous, topical ophthalmic solution in an opaque, white low density polyethylene (LDPE) bottle with a natural LDPE dropper tip and red cap in the following sizes: NDC 0065-0349-05 2 mL in 4 mL bottle NDC 0065-0349-04 15 mL in 15 mL bottle Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% is supplied as a sterile, aqueous, topical ophthalmic solution in an opaque, white low density polyethylene (LDPE) bottle with a natural LDPE dropper tip and red cap in the following sizes: NDC 0065-0343-02 5 mL in 8 mL bottle After opening, Phenylephrine Hydrochloride Ophthalmic Solution, USP can be used until the expiration date on the bottle. Storage: Store at 20°C to 25°C (68°F to 77°F). Keep container tightly closed. Protect from light and excessive heat. Do not use if solution is brown or contains precipitate.
Storage
Storage: Store at 20°C to 25°C (68°F to 77°F). Keep container tightly closed. Protect from light and excessive heat. Do not use if solution is brown or contains precipitate.
Patient information
17. PATIENT COUNSELING INFORMATION Advise patients not to touch the dropper tip to any surface as this may contaminate the solution. Inform patients that they may experience sensitivity to light and should protect their eyes in bright illumination while their pupils are dilated. Distributed by: ALCON LABORATORIES, INC. Fort Worth, Texas 76134 U.S.A.
Label text from the FDA structured product label by Alcon Laboratories, Inc. (revised Apr 1, 2025). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Phenylephrine Hydrochloride in 110 products
Phenylephrine Hydrochloride NDC products (110)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 70121-1579 | Phenylephrine Hydrochloride 10 mg/mL Injection | Amneal Pharmaceuticals LLC | ANDA |
| 70121-1578 | Phenylephrine Hydrochloride 10 mg/mL Injection | Amneal Pharmaceuticals LLC | ANDA |
| 70121-1577 | Phenylephrine Hydrochloride 10 mg/mL Injection | Amneal Pharmaceuticals LLC | ANDA |
| 72485-506 | Phenylephrine Hydrochloride 100 mg/10mL Injection | Armas Pharmaceuticals Inc. | ANDA |
| 72485-505 | Phenylephrine Hydrochloride 50 mg/5mL Injection | Armas Pharmaceuticals Inc. | ANDA |
| 72485-504 | Phenylephrine Hydrochloride 10 mg/mL Injection | Armas Pharmaceuticals Inc. | ANDA |
| 36000-362 | Phenylephrine Hydrochloride 10 mg/mL Injection | Baxter Healthcare Corporation | ANDA |
| 36000-360 | Phenylephrine Hydrochloride 10 mg/mL Injection | Baxter Healthcare Corporation | ANDA |
| 36000-358 | Phenylephrine Hydrochloride 10 mg/mL Injection | Baxter Healthcare Corporation | ANDA |
| 71839-127 | Phenylephrine Hydrochloride 10 mg/mL Injection | BE Pharmaceuticals Inc. | ANDA |
| 71839-128 | Phenylephrine Hydrochloride 10 mg/mL Injection | BE Pharmaceuticals Inc. | ANDA |
| 71839-129 | Phenylephrine Hydrochloride 10 mg/mL Injection | BE Pharmaceuticals Inc. | ANDA |
| 31722-343 | Phenylephrine Hydrochloride 10 mg/mL Injection | Camber Pharmaceuticals, Inc. | ANDA |
| 31722-344 | Phenylephrine Hydrochloride 10 mg/mL Injection | Camber Pharmaceuticals, Inc. | ANDA |
| 31722-345 | Phenylephrine Hydrochloride 10 mg/mL Injection | Camber Pharmaceuticals, Inc. | ANDA |
| 65145-148 | Phenylephrine Hydrochloride 25 mg/mL Solution/ Drops | Caplin Steriles Limited | ANDA |
| 65145-117 | Phenylephrine Hydrochloride 100 mg/10mL Injection | Caplin Steriles Limited | ANDA |
| 65145-116 | Phenylephrine Hydrochloride 50 mg/5mL Injection | Caplin Steriles Limited | ANDA |
| 65145-115 | Phenylephrine Hydrochloride 10 mg/mL Injection | Caplin Steriles Limited | ANDA |
| 65145-149 | Phenylephrine Hydrochloride 25 mg/mL Solution/ Drops | Caplin Steriles Limited | ANDA |
| 65145-150 | Phenylephrine Hydrochloride 100 mg/mL Solution/ Drops | Caplin Steriles Limited | ANDA |
| 55154-8226 | Phenylephrine Hydrochloride 10 mg/mL Injection | Cardinal Health 107, LLC | ANDA |
| 75907-129 | Phenylephrine Hydrochloride 25 mg/mL Solution/ Drops | Dr.Reddy's Laboratories Inc., | ANDA |
| 75907-324 | Phenylephrine Hydrochloride 25 mg/mL Solution/ Drops | Dr.Reddy's Laboratories Inc., | ANDA |
| 75907-130 | Phenylephrine Hydrochloride 100 mg/mL Solution/ Drops | Dr.Reddy's Laboratories Inc., | ANDA |
| 55150-300 | Phenylephrine Hydrochloride 10 mg/mL Injection | Eugia US LLC | ANDA |
| 55150-301 | Phenylephrine Hydrochloride 10 mg/mL Injection | Eugia US LLC | ANDA |
| 55150-302 | Phenylephrine Hydrochloride 10 mg/mL Injection | Eugia US LLC | ANDA |
| 81469-168 | Phenylephrine Hydrochloride 25 mg/mL Solution/ Drops | First Nation Group, LLC | ANDA |
| 81469-169 | Phenylephrine Hydrochloride 100 mg/mL Solution/ Drops | First Nation Group, LLC | ANDA |
| 65219-388 | Phenylephrine Hydrochloride 10 mg/mL Injection | Fresenius Kabi USA, LLC | ANDA |
| 63323-751 | Phenylephrine Hydrochloride 10 mg/mL Injection | Fresenius Kabi USA, LLC | ANDA |
| 68083-338 | Phenylephrine Hydrochloride 10 mg/mL Injection | Gland Pharma Limited | ANDA |
| 68083-339 | Phenylephrine Hydrochloride 10 mg/mL Injection | Gland Pharma Limited | ANDA |
| 68083-680 | Phenylephrine Hydrochloride 25 mg/mL Solution/ Drops | Gland Pharma Limited | ANDA |
| 68083-465 | Phenylephrine Hydrochloride 10 mg/mL Injection | Gland Pharma Limited | ANDA |
| 68083-593 | Phenylephrine Hydrochloride 25 mg/mL Solution/ Drops | Gland Pharma Limited | ANDA |
| 68083-594 | Phenylephrine Hydrochloride 100 mg/mL Solution/ Drops | Gland Pharma Limited | ANDA |
| 14335-441 | Phenylephrine Hydrochloride 10 mg/mL Injection | Hainan Poly Pharm. Co., Ltd. | ANDA |
| 14335-440 | Phenylephrine Hydrochloride 10 mg/mL Injection | Hainan Poly Pharm. Co., Ltd. | ANDA |
| 14335-442 | Phenylephrine Hydrochloride 10 mg/mL Injection | Hainan Poly Pharm. Co., Ltd. | ANDA |
| 0404-9931 | Phenylephrine Hydrochloride 10 mg/mL Injection | Henry Schein, Inc. | ANDA |
| 23155-620 | Phenylephrine Hydrochloride 10 mg/mL Injection | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA |
| 51662-1576 | Phenylephrine Hydrochloride 10 mg/mL Injection | HF Acquisition Co LLC, DBA HealthFirst | ANDA |
| 69315-323 | Phenylephrine Hydrochloride 25 mg/mL Solution | Leading Pharma, LLC | ANDA |
| 69315-324 | Phenylephrine Hydrochloride 100 mg/mL Solution | Leading Pharma, LLC | ANDA |
| 70756-623 | Phenylephrine Hydrochloride 100 mg/10mL Injection | Lifestar Pharma LLC | ANDA |
| 70756-676 | Phenylephrine Hydrochloride 25 mg/mL Solution/ Drops | Lifestar Pharma LLC | ANDA |
| 70756-649 | Phenylephrine Hydrochloride 25 mg/mL Solution/ Drops | Lifestar Pharma LLC | ANDA |
| 70756-629 | Phenylephrine Hydrochloride 25 mg/mL Solution/ Drops | Lifestar Pharma LLC | ANDA |
| 70756-622 | Phenylephrine Hydrochloride 50 mg/5mL Injection | Lifestar Pharma LLC | ANDA |
| 70756-621 | Phenylephrine Hydrochloride 10 mg/mL Injection | Lifestar Pharma LLC | ANDA |
| 70756-614 | Phenylephrine Hydrochloride 100 mg/mL Solution/ Drops | Lifestar Pharma LLC | ANDA |
| 71872-7267 | Phenylephrine Hydrochloride 10 mg/mL Injection | Medical Purchasing Solutions, LLC | ANDA |
| 71872-7159 | Phenylephrine Hydrochloride 10 mg/mL Injection | Medical Purchasing Solutions, LLC | ANDA |
| 71872-7273 | Phenylephrine Hydrochloride 10 mg/mL Injection | Medical Purchasing Solutions, LLC | ANDA |
| 71872-7343 | Phenylephrine Hydrochloride 10 mg/mL Injection | Medical Purchasing Solutions, LLC | ANDA |
| 71872-7348 | Phenylephrine Hydrochloride 10 mg/mL Injection | Medical Purchasing Solutions, LLC. | ANDA |
| 71872-7303 | Phenylephrine Hydrochloride 10 mg/mL Injection | Medical Purhasing Solutions, LLC | ANDA |
| 71288-807 | Phenylephrine Hydrochloride 10 mg/mL Injection | Meitheal Pharmaceuticals Inc. | ANDA |
| 71288-808 | Phenylephrine Hydrochloride 10 mg/mL Injection | Meitheal Pharmaceuticals Inc. | ANDA |
| 58657-853 | Phenylephrine Hydrochloride 10 mg/mL Injection | Method Pharmaceuticals, LLC | ANDA |
| 58657-852 | Phenylephrine Hydrochloride 10 mg/mL Injection | Method Pharmaceuticals, LLC | ANDA |
| 58657-851 | Phenylephrine Hydrochloride 10 mg/mL Injection | Method Pharmaceuticals, LLC | ANDA |
| 72603-530 | Phenylephrine Hydrochloride 100 mg/mL Solution/ Drops | NorthStar RxLLC | ANDA |
| 72603-520 | Phenylephrine Hydrochloride 25 mg/mL Solution/ Drops | NorthStar RxLLC | ANDA |
| 72205-264 | Phenylephrine Hydrochloride 10 mg/mL Injection | Novadoz Pharmaceuticals LLC | ANDA |
| 72205-265 | Phenylephrine Hydrochloride 10 mg/mL Injection | Novadoz Pharmaceuticals LLC | ANDA |
| 72205-266 | Phenylephrine Hydrochloride 10 mg/mL Injection | Novadoz Pharmaceuticals LLC | ANDA |
| 42023-215 | Phenylephrine Hydrochloride 10 mg/mL Injection | Par Health USA, LLC | ANDA |
| 42023-214 | Phenylephrine Hydrochloride 10 mg/mL Injection | Par Health USA, LLC | ANDA |
| 84549-621 | Phenylephrine Hydrochloride 10 mg/mL Injection | ProPharma Distribution | ANDA |
| 81284-213 | Phenylephrine Hydrochloride 10 mg/mL Injection | Provepharm Inc. | ANDA |
| 81284-212 | Phenylephrine Hydrochloride 10 mg/mL Injection | Provepharm Inc. | ANDA |
| 81284-211 | Phenylephrine Hydrochloride 10 mg/mL Injection | Provepharm Inc. | ANDA |
| 25021-315 | Phenylephrine Hydrochloride 10 mg/mL Injection, Solution | Sagent Pharmaceuticals | ANDA |
| 0781-3466 | Phenylephrine Hydrochloride 10 mg/mL Injection | Sandoz Inc | ANDA |
| 0781-9226 | Phenylephrine Hydrochloride 10 mg/mL Injection | Sandoz Inc | ANDA |
| 0781-9227 | Phenylephrine Hydrochloride 10 mg/mL Injection | Sandoz Inc | ANDA |
| 0781-3458 | Phenylephrine Hydrochloride 10 mg/mL Injection | Sandoz Inc | ANDA |
| 0781-3422 | Phenylephrine Hydrochloride 10 mg/mL Injection | Sandoz Inc | ANDA |
| 0781-9228 | Phenylephrine Hydrochloride 10 mg/mL Injection | Sandoz Inc | ANDA |
| 70512-866 | Phenylephrine Hydrochloride 100 mg/mL Solution/ Drops | SOLA Pharmaceuticals, LLC | ANDA |
| 70512-865 | Phenylephrine Hydrochloride 25 mg/mL Solution/ Drops | SOLA Pharmaceuticals, LLC | ANDA |
| 70069-801 | Phenylephrine Hydrochloride 10 mg/mL Injection | Somerset Therapeutics, LLC | ANDA |
| 70069-591 | Phenylephrine Hydrochloride .1 mg/mL Solution | Somerset Therapeutics, LLC | ANDA |
| 70069-802 | Phenylephrine Hydrochloride 50 mg/5mL Injection | Somerset Therapeutics, LLC | ANDA |
| 70069-803 | Phenylephrine Hydrochloride 100 mg/10mL Injection | Somerset Therapeutics, LLC | ANDA |
| 70069-813 | Phenylephrine Hydrochloride 100 mg/10mL Injection | Somerset Therapeutics, LLC | ANDA |
| 70069-812 | Phenylephrine Hydrochloride 50 mg/5mL Injection | Somerset Therapeutics, LLC | ANDA |
| 70069-811 | Phenylephrine Hydrochloride 10 mg/mL Injection | Somerset Therapeutics, LLC | ANDA |
| 70594-065 | Phenylephrine Hydrochloride 100 mg/10mL Injection | Xellia Pharmaceuticals USA LLC | ANDA |
| 70594-064 | Phenylephrine Hydrochloride 50 mg/5mL Injection | Xellia Pharmaceuticals USA LLC | ANDA |
| 70594-063 | Phenylephrine Hydrochloride 10 mg/mL Injection | Xellia Pharmaceuticals USA LLC | ANDA |
| 14803-003 | Phenylephrine Hydrochloride 10 mg/1 Tablet | Elysium Pharmaceuticals Limited | DRUG FOR FURTHER PROCESSING |
| 0065-0343 | Phenylephrine Hydrochloride 100 mg/mL Solution/ Drops | Alcon Laboratories, Inc. | NDA |
| 0065-0349 | Phenylephrine Hydrochloride 25 mg/mL Solution/ Drops | Alcon Laboratories, Inc. | NDA |
| 72572-571 | Phenylephrine Hydrochloride 10 mg/mL Injection | Civica, Inc. | NDA |
| 72572-570 | Phenylephrine Hydrochloride 10 mg/mL Injection | Civica, Inc. | NDA |
| 0641-6229 | Phenylephrine Hydrochloride 10 mg/mL Injection | Hikma Pharmaceuticals USA Inc. | NDA |
| 0641-6189 | Phenylephrine Hydrochloride 10 mg/mL Injection | Hikma Pharmaceuticals USA Inc. | NDA |
| 0641-6188 | Phenylephrine Hydrochloride 10 mg/mL Injection | Hikma Pharmaceuticals USA Inc. | NDA |
| 0641-6142 | Phenylephrine Hydrochloride 10 mg/mL Injection | Hikma Pharmaceuticals USA Inc. | NDA |
| 71872-7043 | Phenylephrine Hydrochloride 10 mg/mL Injection | Medical Purchasing Solutions, LLC | NDA |
| 42702-103 | Phenylephrine Hydrochloride 100 mg/mL Solution/ Drops | Paragon BioTeck, Inc. | NDA |
| 42702-102 | Phenylephrine Hydrochloride 25 mg/mL Solution/ Drops | Paragon BioTeck, Inc. | NDA |
| 82260-102 | Phenylephrine Hydrochloride 25 mg/mL Solution/ Drops | Bausch & Lomb Americas Inc. | NDA AUTHORIZED GENERIC |
| 82260-103 | Phenylephrine Hydrochloride 25 mg/mL Solution/ Drops | Bausch & Lomb Americas Inc. | NDA AUTHORIZED GENERIC |
| 83586-010 | Phenylephrine Hydrochloride 10 mg/1 Tablet | HHH Pharmaceuticals | OTC MONOGRAPH DRUG |
| 57631-018 | Phenylephrine Hydrochloride 10 mg/1 Tablet | InvaTech Pharma Solutions LLC | OTC MONOGRAPH DRUG |
Phenylephrine Hydrochloride recalls
- D-0305-2021 Mar 24, 2021 · Class II · Terminated
Lack of Assurance of Sterility: customer complaints of loose crimped vial overseals which may result in a non-sterile product.
Frequently asked questions
What is Phenylephrine Hydrochloride used for?
Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10%, is indicated to dilate the pupil. Phenylephrine Hydrochloride Ophthalmic Solution is an alpha-1 adrenergic receptor agonist indicated to dilate the pupil ( 1 )
What are the side effects of Phenylephrine Hydrochloride?
The following serious adverse reactions are described below and elsewhere in the labeling: Cardiovascular Effects [ See Warnings and Precautions ( 5.2 )] Elevation in Blood Pressure [ See Warnings and Precautions ( 5.3 )] The following adverse reactions have been identified following use of phenylephrine hydrochloride ophthalmic solution. Because these reactions are reported voluntarily from a… See the full label for the complete list.
Who makes Phenylephrine Hydrochloride?
Phenylephrine Hydrochloride is listed by 41 labelers in the FDA NDC directory, including Amneal Pharmaceuticals LLC, Armas Pharmaceuticals Inc., Baxter Healthcare Corporation, BE Pharmaceuticals Inc..
Has Phenylephrine Hydrochloride been recalled?
The FDA enforcement database lists 1 recall for Phenylephrine Hydrochloride, most recently D-0305-2021 (class ii): Lack of Assurance of Sterility: customer complaints of loose crimped vial overseals which may result in a non-sterile product.