Phenylephrine Hydrochloride - First Nation Group, LLC | Mankind Pharma Limited

Phenylephrine Hydrochloride Ophthalmic Solution 2.5% and 10%, is indicated to dilate the pupil.

Phenylephrine hydrochloride ophthalmic solution, USP 2.5% is a clear, colorless to yellow colored sterile topical ophthalmic solution containing phenylephrine hydrochloride 2.5%.: each mL contains 25 mg of phenylephrine hydrochloride, USP.

Phenylephrine hydrochloride ophthalmic solution, USP 10% is a clear, colorless, to yellow colored sterile topical ophthalmic solution containing phenylephrine hydrochloride 10%.: each mL contains 100 mg of phenylephrine hydrochloride, USP.

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.

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.

Phenylephrine Hydrochloride Ophthalmic Solution, USP is a sterile, clear, colorless to yellow color solution, 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: C₉H₁₃NO_2.HCl

Molecular Weight: 203.67 g/mol

Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% contains: ACTIVE: Phenylephrine Hydrochloride, USP 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%).

Pupillary dilation following topical administration of phenylephrine hydrochloride ophthalmic solution has been demonstrated in controlled clinical studies in adults and pediatric patients with different levels of iris pigmentation. Pupil movement is generally seen within 15 minutes, maximal mydriasis between 20 to 90 minutes and recovery after 3 to 8 hours. Darker irides tend to dilate slower than lighter irides.

Phenylephrine hydrochloride ophthalmic solution, USP 2.5% is supplied as a clear, colorless to yellow colored 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 81469-168-02                2 mL in 5 mL bottle

NDC 81469-168-15               15 mL in 15 mL bottle

Phenylephrine hydrochloride ophthalmic solution, USP 10% is supplied as a sterile, clear, colorless to yellow color, 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 81469-169-05                5 mL in 10 mL bottle

After opening, Phenylephrine Hydrochloride Ophthalmic Solution, USP can be use until the expiration date on the bottle.

Storage: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Keep container tightly closed. Protect from light and excessive heat.

Do not use if solution is brown or contains precipitate.

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.

Manufactured for:

First Nation Group, LLC

4566 E Highway 20,

Suite #208

Niceville, FL 32578-8839

Product of Taiwan

Revised: December 2025, V-01

NDC 81469-168-02

Phenylephrine Hydrochloride Ophthalmic Solution, USP

2.5%

For Topical Application in the Eye.

Not for Injection

2 mL

Rx only

NDC 81469-168-02

Phenylephrine Hydrochloride Ophthalmic Solution, USP

2.5%

For Topical Application in the Eye.

Not for Injection

2 mL

Rx only

NDC 81469-168-15

Phenylephrine Hydrochloride Ophthalmic Solution, USP

2.5%

For Topical Application in the Eye.

Not for Injection

15 mL

Rx only

NDC 81469-168-15

Phenylephrine Hydrochloride Ophthalmic Solution, USP

2.5%

For Topical Application in the Eye.

Not for Injection

15 mL

Rx only

NDC 81469-169-05

Phenylephrine Hydrochloride Ophthalmic Solution, USP

10%

For Topical Application in the Eye.

Not for Injection

5 mL

Rx only

NDC 81469-169-05

Phenylephrine Hydrochloride Ophthalmic Solution, USP

10%

For Topical Application in the Eye.

Not for Injection

5 mL

Rx only