Quick answers
- What is Cyclopentolate hydrochloride and phenylephrine hydrochloride used for?
- The FDA-approved label (Cyclomydril, Alcon Laboratories, Inc., May 15, 2025) says: “For the production of mydriasis.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the side effects of Cyclopentolate hydrochloride and phenylephrine hydrochloride?
- The “Adverse Reactions” section of the FDA label (Cyclomydril, Alcon Laboratories, Inc., May 15, 2025) begins: “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.” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Cyclopentolate hydrochloride and phenylephrine hydrochloride have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Cyclopentolate hydrochloride and phenylephrine hydrochloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Cyclopentolate hydrochloride and phenylephrine hydrochloride been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Cyclopentolate hydrochloride and phenylephrine hydrochloride?
- 1 company lists prescription products of Cyclopentolate hydrochloride and phenylephrine hydrochloride in the FDA NDC Directory, including Alcon Laboratories, Inc.
What Cyclopentolate hydrochloride and phenylephrine hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
For the production of mydriasis.
— FDA label: Cyclomydril, Alcon Laboratories, Inc., effective May 15, 2025. Read the full label on DailyMed →
Label quoted: the one for the most common form (solution/ drops, ophthalmic), Cyclomydril, Alcon Laboratories, Inc.; it covers 1 product in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Cyclopentolate hydrochloride and phenylephrine hydrochloride side effects
Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.
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.
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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.
— FDA label: Cyclomydril, Alcon Laboratories, Inc., effective May 15, 2025. Read the full label on DailyMed →
Cyclopentolate hydrochloride and phenylephrine hydrochloride dosage
Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.
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.
— FDA label: Cyclomydril, Alcon Laboratories, Inc., effective May 15, 2025. Read the full label on DailyMed →
Cyclopentolate hydrochloride and phenylephrine hydrochloride in pregnancy
Quoted from the pregnancy part of the FDA-approved label. Ask your doctor before you take any medicine while pregnant or planning a pregnancy.
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.
— FDA label: Cyclomydril, Alcon Laboratories, Inc., effective May 15, 2025. Read the full label on DailyMed →
Cyclopentolate hydrochloride and phenylephrine hydrochloride and breastfeeding
Quoted from the nursing mothers / lactation part of the FDA-approved label.
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.
— FDA label: Cyclomydril, Alcon Laboratories, Inc., effective May 15, 2025. Read the full label on DailyMed →
When Cyclopentolate hydrochloride and phenylephrine hydrochloride should not be used
Quoted from the “Contraindications” section of the FDA-approved label.
Do not use in patients with hypersensitivity to any component of this preparation.
— FDA label: Cyclomydril, Alcon Laboratories, Inc., effective May 15, 2025. Read the full label on DailyMed →
Cyclopentolate hydrochloride and phenylephrine hydrochloride overdose
Quoted from the “Overdosage” section of the FDA-approved label. If someone may have taken too much, call Poison Help at 1-800-222-1222 (or 911 in an emergency).
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.
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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.
— FDA label: Cyclomydril, Alcon Laboratories, Inc., effective May 15, 2025. Read the full label on DailyMed →
Forms and how it is given
| Dosage forms | Solution/ drops |
|---|---|
| Route | Ophthalmic |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Cyclomydril |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Alcon Laboratories, Inc.1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (1)
- ANDA084300Alcon Labs Inc · September 12, 1975
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 1298068, 1298360 |
|---|---|
| SPL set ID of the quoted label | 8268b70f-3f10-48dd-bb24-baaeb27a1325 |
| FDA labels (SPL) | 1 |
| FDA applications | 1 ANDA |
| Active ingredients (FDA) | CYCLOPENTOLATE / PHENYLEPHRINE |
Next steps
- Find a pharmacy near youAsk which price applies to you and whether your product is affected by a recall
- Latest FDA drug recallsAll medicines, newest first
- Alcon Laboratories, Inc.Maker or distributor
- All prescription drugs A to ZSearch by generic, brand or Spanish name
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Cyclomydril, Alcon Laboratories, Inc., effective May 15, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →