Phenylephrine Hydrochloride

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

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.

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, 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: C₉H₁₃NO₂.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%).

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 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.

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.

Principal Display Panel Text for Container Label:

Phenylephrine Hydrochloride
Ophthalmic Solution, USP

2.5%

Sterile
Rx only

Alcon

2mL

NDC 0065-0349-05
Each mL contains: Active:
Phenylephrine Hydrochloride (2.5%)
Storage: Store at 20ºC-25ºC (68ºF-77ºF).
Dosage: see Prescribing Information
ALCON LABORATORIES, INC.
Fort Worth, Texas 76134 USA

LOT:               EXP.:

300066881-0924

Principal Display Panel Text for Carton Label:

Rx only
Sterile

NDC 0065-0349-05

Phenylephrine
Hydrochloride
Ophthalmic
Solution, USP 2.5%

FOR TOPICAL APPLICATION IN THE EYE

2mL

Alcon

Each mL contains:
Active: Phenylephrine
Hydrochloride 25 mg (2.5%);
Inactives: Sodium Phosphate
Dibasic, Sodium Phosphate
Monobasic, Sodium Hydroxide
and/or Phosphoric Acid may be
added to adjust pH (4.0 to 7.5)
and Water for Injection q.s.;
Preservative: Benzalkonium
Chloride 0.1 mg (0.01%).

Dosage: see Prescribing
Information.
Storage: Store at 20ºC to 25ºC
(68ºF to 77ºF). Keep tightly
closed. Protect from light and
excessive heat.
Do not use if solution is
brown or contains a
precipitate.


KEEP OUT OF REACH OF
CHILDREN.

DO NOT USE IF IMPRINTED
SEAL IS BROKEN OR MISSING.

ALCON LABORATORIES, INC.
6201 South Freeway
Fort Worth, Texas 76134 USA
1-800-757-9195
alcon.medinfor@alcon.com
Printed in USA

300066873-0924

SN:
LOT:
EXP.:
GTIN: 00300650349055

Principal Display Panel Text for Container Label:

NDC 0065-0349-04

15mL

300066880-0924

Principal Display Panel Text for Carton Label:

NDC 0065-0349-04

15mL

300066872-0924

SN:
LOT:
EXP.:
GTIN: 00300650349048

Principal Display Panel Text for Container Label:

NDC 0065-0343-02

Phenylephrine
Hydrochloride
Ophthalmic
Solution, USP

10%

FOR TOPICAL APPLICATION
IN THE EYE

Sterile Rx
only 

Alcon

5 mL

Each mL contains: Active:
Phenylephrine Hydrochloride (10%);
Inactives: Sodium
Phosphate Dibasic, Sodium
Phosphate Monobasic, Sodium
Hydroxide and/or Phosphoric Acid
may be added to adjust pH (4.0 to
7.5) and Water for Injection q.s.;
Preservative: Benzalkonium
Chloride 0.1 mg (0.01%).


Dosage: see Prescribing
Information.
Storage: Store at 20ºC to 25ºC
(68ºF to 77ºF). Keep container
tightly closed. Do not use if
solution is brown or contains a
precipitate.
DO NOT USE IF IMPRINTED
SEAL IS BROKEN OR MISSING.

ALCON LABORATORIES, INC.
Fort Worth, Texas 76134 USA

LOT:                        EXP.:

30006 7943-0225

Principal Display Panel Text for Carton Label:

NDC 0065-343-02

KEEP OUT OF REACH OF
CHILDREN

ALCON LABORATORIES, INC.
6201 South Freeway
Fort Worth, Texas 76134 USA
1-800-757-9195
alcon.medinfor@alcon.com
Printed in USA

SN:
LOT:
EXP.:
GTIN: 00300650343022

300067876-0225