Phenylephrine Hydrochloride

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• 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.
• 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.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Quoted from the official label, section “Overdosage”.

Use in children

Phenylephrine hydrochloride ophthalmic solution 10% is contraindicated in pediatric patients less than 1 year of age [S ee Contraindications (4.2) ].

Quoted from the official label, section “Pediatric Use”.

Use in older people

No overall differences in safety and effectiveness have been observed between elderly and younger adult patients.

Quoted from the official label, section “Geriatric Use”.

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 LEADING PHARMA,LLC AT 1-844-740-7500 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) ].
• 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) ].

Quoted from the official label, section “Adverse Reactions”.

Strengths and forms

• FORMS AND STRENGTHS Phenylephrine hydrochloride ophthalmic solution, USP 2.5% is a clear, colorless to yellow solution, 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 solution, 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%)

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• 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 69315-323-08 2 mL in 5 mL bottle NDC 69315-323-15 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 69315-324-05 5 mL in 10 mL bottle After opening, Phenylephrine Hydrochloride Ophthalmic Solution, USP can be used until the expiration date on the bottle.
• Storage: Store at 20° to 25°C (68° to 77°F).
• Keep container tightly closed.
• Protect from light and excessive heat.
• Do not use if solution is brown or contains precipitate.

Quoted from the official label, section “How Supplied”.

What is in it

• Phenylephrine Hydrochloride Ophthalmic Solution, USP is a sterile, clear, colorless, 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 Dibasic, Sodium Phosphate Monobasic, 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 Dibasic, Sodium Phosphate Monobasic, 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%). chemicalstructure

Quoted from the official label, section “Description”.

Ingredients people check for

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Same active substance, strength and form in other countries

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Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

62 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

See every product with Phenylephrine Hydrochloride