Cyclomydril®

For the production of mydriasis.

Instill one drop in each eye every five to ten minutes. To minimize systemic absorption, apply pressure over the nasolacrimal sac for two to three minutes following instillation. Observe infants closely for at least 30 minutes.

Do not use in patients with hypersensitivity to any component of this preparation.

Ocular

The following ocular adverse experiences have been associated with the use of CYCLOMYDRIL^® (cyclopentolate hydrochloride and phenylephrine hydrochloride ophthalmic solution): increased intraocular pressure, burning/irritation upon instillation, photophobia, blurred vision and superficial punctate keratitis.

Nonocular

Use of cyclopentolate hydrochloride has been associated with psychotic reactions and behavioral disturbances in children. These disturbances include ataxia, incoherent speech, restlessness, hallucinations, hyperactivity, seizures, disorientation as to time and place. This drug produces reactions similar to those of other adrenergic and anticholinergic drugs; however, the central nervous system manifestations as noted above are most common. Other manifestations of adrenergic and anticholinergic topical ophthalmic drugs include tachycardia, hyperpyrexia, hypertension, vasodilation, urinary retention, diminished gastrointestinal motility, convulsion, bradycardia, apnea, necrotizing colitis and abdominal distention (in newborns and especially premature infants), skin rash, drowsiness, and decreased secretion in salivary and sweat glands, pharynx, bronchi and nasal passages. Severe manifestations of toxicity include coma, medullary paralysis and death. Systemic toxicity can result from topical application of sympathomimetic drugs: headache, blood pressure elevation, extrasystoles, tachycardia, syncope and cerebrovascular accidents have been reported.

CYCLOMYDRIL^® (cyclopentolate hydrochloride and phenylephrine hydrochloride ophthalmic solution) is supplied as a sterile solution in 2 mL and 5 mL, in plastic DROP-TAINER® dispensers.

2 mL           NDC 0065-0359-02

5 mL           NDC 0065-0359-05

Storage: Store at 8°C to 25°C (46°F - 77°F)

CYCLOMYDRIL^® (cyclopentolate hydrochloride and phenylephrine hydrochloride ophthalmic solution) is a mydriatic prepared as a sterile topical ophthalmic solution. The active ingredients are represented by the chemical structures:

Established Name:

Cyclopentolate Hydrochloride

Chemical Name:

2-(Dimethylamino)ethyl 1 - hydroxy-α-phenylcyclopentaneacetate hydrochloride)

Molecular Formula:

C₁₇H₂₅NO₃ • HCl

Molecular Weight:

327.85 g/mol

Established Name:

Phenylephrine Hydrochloride

Chemical Name:

3-hydroxy-α[(methylamino)-methyl]-, Benzenemethanol, hydrochloride (R)-.

Molecular Formula:

C₉H₁₃NO₂ • HCl

Molecular Weight:

203.67 g/mol

Each mL of CYCLOMYDRIL^® (cyclopentolate hydrochloride and phenylephrine hydrochloride ophthalmic solution) contains:

Active: cyclopentolate hydrochloride 0.2%, phenylephrine hydrochloride 1%. Preservative: benzalkonium chloride 0.01%.

Inactives: edetate disodium, boric acid, hydrochloric acid and /or sodium carbonate (to adjust pH), purified water.

Distributed by:

ALCON LABORATORIES, INC.

6201 South Freeway

Fort Worth, Texas 76134-2099

© 2025 Alcon Inc.

Revised: May 2025.



300065206-1223

Caution should be observed when considering use of this medication in the presence of Down's syndrome due to potential increased sensitivity to anticholinergics. This product should be used with caution in patients at risk for angle closure due to the potential to precipitate acute angle closure. Because of the risk of provoking hyperthermia, use with caution in patients, especially children, who may be exposed to elevated environmental temperatures or who are febrile.  The use of phenylephrine in the eye may liberate pigment granules from the iris. Mydriatics may produce a transient elevation of intraocular pressure.

FOR TOPICAL OPHTHALMIC USE ONLY. NOT FOR INJECTION. There have been reports of serious cardiovascular reactions, including ventricular arrhythmias and myocardial infarctions, in patients using higher concentrations of phenylephrine. These episodes, some fatal, have usually occurred in patients with pre-existing cardiovascular diseases. This preparation may cause central nervous system (CNS) disturbances. This is especially true in younger age groups, but may occur at any age, especially with the stronger solutions. Infants are especially prone to CNS and cardiopulmonary side effects from cyclopentolate.

Animal reproduction studies have not been conducted with cyclopentolate hydrochloride and/or phenylephrine hydrochloride. It is also not known whether cyclopentolate hydrochloride and/or phenylephrine hydrochloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. CYCLOMYDRIL^® (cyclopentolate hydrochloride and phenylephrine hydrochloride ophthalmic solution) should be given to a pregnant woman only if clearly needed.

Excessive dosage may produce behavioral disturbances, tachycardia, hyperpyrexia, hypertension, elevated intraocular pressure, vasodilation, urinary retention, diminished gastrointestinal motility and decreased secretion in salivary and sweat glands, pharynx, bronchi and nasal passages. Pulmonary oedema or cardiac arrest may occur due to phenylephrine toxicity.  Severe intoxication is characterized by central nervous system depression, coma, circulatory and respiratory failure, and death.

Patients exhibiting signs of overdosage should receive supportive care and monitoring.

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

Use of cyclopentolate has been associated with psychotic reactions and behavioral disturbances in pediatric patients. Increased susceptibility to cyclopentolate has been reported in infants, young children, and in children with spastic paralysis or brain damage. These disturbances include ataxia, incoherent speech, restlessness, hallucinations, hyperactivity, seizures, disorientation as to time and place. Feeding intolerance may follow ophthalmic use of this product in infants. It is recommended that feeding be withheld after administration, and to observe infants closely for at least 30 minutes (see PRECAUTIONS).

It is not known whether these drugs are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when CYCLOMYDRIL^® (cyclopentolate hydrochloride and phenylephrine hydrochloride ophthalmic solution) is administered to a nursing woman.

Cyclopentolate hydrochloride is an anticholinergic drug and phenylephrine hydrochloride is an adrenergic drug. This combination induces mydriasis that is greater than that of either drug alone at its respective concentration. The concentrations of cyclopentolate hydrochloride and phenylephrine hydrochloride have been selected to induce mydriasis with little accompanying cycloplegia. Heavily pigmented irides may require more doses than lightly pigmented irides.

NDC 0065-0359-05



Alcon

Cyclomydril^®

(cyclopentolate

hydrochloride,

phenylephrine

hydrochloride

ophthalmic

solution)



5 mL Sterile



Rx Only



Sterile Ophthalmic Solution



USUAL DOSAGE: Instill one drop

in each eye every five to ten

minutes. Read enclosed insert.



FOR TOPICAL OPHTHALMIC USE

ONLY



WARNING: Do not touch

dropper tip to any surface as

this may contaminate the

solution.



INGREDIENTS: Each mL

contains: Active:

cyclopentolate hydrochloride

0.2%, phenylephrine

hydrochloride 1%.

Preservative: benzalkonium

chloride 0.01%. Inactives:

edetate disodium, boric acid,

hydrochloric acid and/or

sodium carbonate (to adjust

pH), purified water.



STORAGE: Store at 8°-25° C

(46° to 77° F).



Alcon



ALCON LABORATORIES, INC.

Fort Worth, Texas 76134 USA

Printed in USA



SN:

LOT:

EXP.:

GTIN: 00300650359054





300048632-0821

NDC 0065-0359-05



Alcon

Cyclomydril^®

(cyclopentolate

hydrochloride,

phenylephrine

hydrochloride

ophthalmic

solution)



Sterile 5 mL



Rx Only



INGREDIENTS: Each mL contains: Actives: cyclopentolate

hydrochloride 0.2%, phenylephrine hydrochloride 1%.

Preservative: benzalkonium chloride 0.01%. Inactives:

edetate disodium, boric acid, hydrochloric acid and/or

sodium carbonate (to adjust pH), purified water.



WARNING: Do not touch dropper tip to any surface as this

may contaminate the solution.



USUAL DOSAGE: Instill one drop in each eye every five to

ten minutes. Read enclosed insert.



STORAGE: Store at 8°-25° C (46° to 77° F).



Printed in USA



ALCON LABORATORIES, INC.

Fort Worth, Texas 76134 USA



LOT:



EXP.:



300048631-0821

Do not touch dropper tip to any surface, as this may contaminate the solution. Patient should be advised not to drive or engage in hazardous activities while pupils are dilated. Patient may experience sensitivity to light.

There have been no long-term studies done using cyclopentolate hydrochloride and/or phenylephrine hydrochloride in animals to evaluate carcinogenic potential.

Distributed by:

ALCON LABORATORIES, INC.

6201 South Freeway

Fort Worth, Texas 76134-2099

© 2025 Alcon Inc.

Revised: May 2025.



300065206-1223

Caution should be observed when considering use of this medication in the presence of Down's syndrome due to potential increased sensitivity to anticholinergics. This product should be used with caution in patients at risk for angle closure due to the potential to precipitate acute angle closure. Because of the risk of provoking hyperthermia, use with caution in patients, especially children, who may be exposed to elevated environmental temperatures or who are febrile.  The use of phenylephrine in the eye may liberate pigment granules from the iris. Mydriatics may produce a transient elevation of intraocular pressure.

FOR TOPICAL OPHTHALMIC USE ONLY. NOT FOR INJECTION. There have been reports of serious cardiovascular reactions, including ventricular arrhythmias and myocardial infarctions, in patients using higher concentrations of phenylephrine. These episodes, some fatal, have usually occurred in patients with pre-existing cardiovascular diseases. This preparation may cause central nervous system (CNS) disturbances. This is especially true in younger age groups, but may occur at any age, especially with the stronger solutions. Infants are especially prone to CNS and cardiopulmonary side effects from cyclopentolate.

Animal reproduction studies have not been conducted with cyclopentolate hydrochloride and/or phenylephrine hydrochloride. It is also not known whether cyclopentolate hydrochloride and/or phenylephrine hydrochloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. CYCLOMYDRIL^® (cyclopentolate hydrochloride and phenylephrine hydrochloride ophthalmic solution) should be given to a pregnant woman only if clearly needed.

Excessive dosage may produce behavioral disturbances, tachycardia, hyperpyrexia, hypertension, elevated intraocular pressure, vasodilation, urinary retention, diminished gastrointestinal motility and decreased secretion in salivary and sweat glands, pharynx, bronchi and nasal passages. Pulmonary oedema or cardiac arrest may occur due to phenylephrine toxicity.  Severe intoxication is characterized by central nervous system depression, coma, circulatory and respiratory failure, and death.

Patients exhibiting signs of overdosage should receive supportive care and monitoring.

CYCLOMYDRIL^® (cyclopentolate hydrochloride and phenylephrine hydrochloride ophthalmic solution) is a mydriatic prepared as a sterile topical ophthalmic solution. The active ingredients are represented by the chemical structures:

Established Name:

Cyclopentolate Hydrochloride

Chemical Name:

2-(Dimethylamino)ethyl 1 - hydroxy-α-phenylcyclopentaneacetate hydrochloride)

Molecular Formula:

C₁₇H₂₅NO₃ • HCl

Molecular Weight:

327.85 g/mol

Established Name:

Phenylephrine Hydrochloride

Chemical Name:

3-hydroxy-α[(methylamino)-methyl]-, Benzenemethanol, hydrochloride (R)-.

Molecular Formula:

C₉H₁₃NO₂ • HCl

Molecular Weight:

203.67 g/mol

Each mL of CYCLOMYDRIL^® (cyclopentolate hydrochloride and phenylephrine hydrochloride ophthalmic solution) contains:

Active: cyclopentolate hydrochloride 0.2%, phenylephrine hydrochloride 1%. Preservative: benzalkonium chloride 0.01%.

Inactives: edetate disodium, boric acid, hydrochloric acid and /or sodium carbonate (to adjust pH), purified water.

CYCLOMYDRIL^® (cyclopentolate hydrochloride and phenylephrine hydrochloride ophthalmic solution) is supplied as a sterile solution in 2 mL and 5 mL, in plastic DROP-TAINER® dispensers.

2 mL           NDC 0065-0359-02

5 mL           NDC 0065-0359-05

Storage: Store at 8°C to 25°C (46°F - 77°F)

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

Use of cyclopentolate has been associated with psychotic reactions and behavioral disturbances in pediatric patients. Increased susceptibility to cyclopentolate has been reported in infants, young children, and in children with spastic paralysis or brain damage. These disturbances include ataxia, incoherent speech, restlessness, hallucinations, hyperactivity, seizures, disorientation as to time and place. Feeding intolerance may follow ophthalmic use of this product in infants. It is recommended that feeding be withheld after administration, and to observe infants closely for at least 30 minutes (see PRECAUTIONS).

It is not known whether these drugs are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when CYCLOMYDRIL^® (cyclopentolate hydrochloride and phenylephrine hydrochloride ophthalmic solution) is administered to a nursing woman.

Ocular

The following ocular adverse experiences have been associated with the use of CYCLOMYDRIL^® (cyclopentolate hydrochloride and phenylephrine hydrochloride ophthalmic solution): increased intraocular pressure, burning/irritation upon instillation, photophobia, blurred vision and superficial punctate keratitis.

Nonocular

Use of cyclopentolate hydrochloride has been associated with psychotic reactions and behavioral disturbances in children. These disturbances include ataxia, incoherent speech, restlessness, hallucinations, hyperactivity, seizures, disorientation as to time and place. This drug produces reactions similar to those of other adrenergic and anticholinergic drugs; however, the central nervous system manifestations as noted above are most common. Other manifestations of adrenergic and anticholinergic topical ophthalmic drugs include tachycardia, hyperpyrexia, hypertension, vasodilation, urinary retention, diminished gastrointestinal motility, convulsion, bradycardia, apnea, necrotizing colitis and abdominal distention (in newborns and especially premature infants), skin rash, drowsiness, and decreased secretion in salivary and sweat glands, pharynx, bronchi and nasal passages. Severe manifestations of toxicity include coma, medullary paralysis and death. Systemic toxicity can result from topical application of sympathomimetic drugs: headache, blood pressure elevation, extrasystoles, tachycardia, syncope and cerebrovascular accidents have been reported.

Do not use in patients with hypersensitivity to any component of this preparation.

Cyclopentolate hydrochloride is an anticholinergic drug and phenylephrine hydrochloride is an adrenergic drug. This combination induces mydriasis that is greater than that of either drug alone at its respective concentration. The concentrations of cyclopentolate hydrochloride and phenylephrine hydrochloride have been selected to induce mydriasis with little accompanying cycloplegia. Heavily pigmented irides may require more doses than lightly pigmented irides.

For the production of mydriasis.

NDC 0065-0359-05



Alcon

Cyclomydril^®

(cyclopentolate

hydrochloride,

phenylephrine

hydrochloride

ophthalmic

solution)



5 mL Sterile



Rx Only



Sterile Ophthalmic Solution



USUAL DOSAGE: Instill one drop

in each eye every five to ten

minutes. Read enclosed insert.



FOR TOPICAL OPHTHALMIC USE

ONLY



WARNING: Do not touch

dropper tip to any surface as

this may contaminate the

solution.



INGREDIENTS: Each mL

contains: Active:

cyclopentolate hydrochloride

0.2%, phenylephrine

hydrochloride 1%.

Preservative: benzalkonium

chloride 0.01%. Inactives:

edetate disodium, boric acid,

hydrochloric acid and/or

sodium carbonate (to adjust

pH), purified water.



STORAGE: Store at 8°-25° C

(46° to 77° F).



Alcon



ALCON LABORATORIES, INC.

Fort Worth, Texas 76134 USA

Printed in USA



SN:

LOT:

EXP.:

GTIN: 00300650359054





300048632-0821

NDC 0065-0359-05



Alcon

Cyclomydril^®

(cyclopentolate

hydrochloride,

phenylephrine

hydrochloride

ophthalmic

solution)



Sterile 5 mL



Rx Only



INGREDIENTS: Each mL contains: Actives: cyclopentolate

hydrochloride 0.2%, phenylephrine hydrochloride 1%.

Preservative: benzalkonium chloride 0.01%. Inactives:

edetate disodium, boric acid, hydrochloric acid and/or

sodium carbonate (to adjust pH), purified water.



WARNING: Do not touch dropper tip to any surface as this

may contaminate the solution.



USUAL DOSAGE: Instill one drop in each eye every five to

ten minutes. Read enclosed insert.



STORAGE: Store at 8°-25° C (46° to 77° F).



Printed in USA



ALCON LABORATORIES, INC.

Fort Worth, Texas 76134 USA



LOT:



EXP.:



300048631-0821

Do not touch dropper tip to any surface, as this may contaminate the solution. Patient should be advised not to drive or engage in hazardous activities while pupils are dilated. Patient may experience sensitivity to light.

Instill one drop in each eye every five to ten minutes. To minimize systemic absorption, apply pressure over the nasolacrimal sac for two to three minutes following instillation. Observe infants closely for at least 30 minutes.

There have been no long-term studies done using cyclopentolate hydrochloride and/or phenylephrine hydrochloride in animals to evaluate carcinogenic potential.