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Fresh Clear

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Active ingredient
Phenylephrine Hydrochloride 1.2 mg/1 mL
Other brand names
Dosage form
Solution/ Drops
Route
Ophthalmic
Prescription status
Rx (prescription)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2011
Label revision date
February 1, 2019
FDA Insert
Prescribing information, PDF file
Active ingredient
Phenylephrine Hydrochloride 1.2 mg/1 mL
Other brand names
Dosage form
Solution/ Drops
Route
Ophthalmic
Prescription status
Rx (prescription)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2011
Label revision date
February 1, 2019
Manufacturer
Allergan, Inc.
NDC root
0023-0000
FDA Insert
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

FRESHCLEAR® is a sterile solution that contains two active ingredients: fenilefrina (a medication that helps to relieve nasal congestion) and alcohol polivinílico (a polymer used to help keep the solution stable and effective). This formulation is designed to provide relief from symptoms associated with nasal congestion, making it easier for you to breathe comfortably.

Packaged in a 15 mL dropper bottle, FRESHCLEAR® is manufactured by Allergan and has been available since February 1, 2019. If you're looking for a solution to help alleviate nasal congestion, FRESHCLEAR® may be a suitable option for you.

Uses

It seems that the information provided does not include specific uses or indications for the medication. Without explicit details on what the drug is used for, I can't provide a consumer-friendly summary. If you have any other information or a different list of uses, please share that, and I would be happy to help!

Dosage and Administration

When using this medication, you will be applying it directly to your eyes as an ophthalmic (eye) solution. The active ingredient in this solution is phenylephrine hydrochloride, which is present at a strength of 1.2 mg in every 1 mL of the solution.

To use the drops, simply follow the instructions provided by your healthcare provider or the product label. Make sure to administer the drops carefully to ensure they reach your eyes effectively. Always remember to wash your hands before and after using the drops to maintain hygiene.

What to Avoid

It's important to be aware of certain precautions when considering this medication. While specific contraindications (conditions that would make the use of the drug inadvisable) and details about controlled substance classification are not provided, you should always consult with your healthcare provider to ensure this medication is safe for you.

Additionally, be cautious about the potential for abuse or misuse, as well as concerns regarding dependence (a condition where your body becomes reliant on a substance). Always follow your healthcare provider's instructions and do not take or use this medication without their guidance. If you have any questions or concerns, don't hesitate to reach out to your healthcare professional for more information.

Side Effects

You may experience some side effects while using this medication. Common reactions include headaches, dizziness, and tremors. You might also notice burning, stinging, or blurred vision, along with feelings of nausea or vomiting. Some people report skin rashes or itching, and respiratory issues like shortness of breath can occur.

It's important to be aware that severe allergic reactions, including anaphylaxis (a serious, life-threatening reaction), can happen. Additionally, cardiovascular effects such as high blood pressure, irregular heartbeats, and reflex bradycardia (a slower than normal heart rate) may occur, especially in individuals with pre-existing heart conditions, hypertension, or hyperthyroidism. If you experience any severe symptoms, please seek medical attention promptly.

Warnings and Precautions

While there are no specific warnings or precautions listed for this medication, it's always important to stay vigilant about your health. If you experience any unusual symptoms or reactions while taking this medication, you should stop using it and contact your doctor for guidance.

Additionally, if you ever feel that you need immediate medical assistance, don't hesitate to seek emergency help. It's crucial to prioritize your well-being and communicate openly with your healthcare provider about any concerns you may have.

Overdose

Taking too much phenylephrine hydrochloride can lead to serious health issues. If you experience symptoms such as high blood pressure (hypertension), slow heart rate (bradycardia), or other heart-related effects, it may indicate an overdose.

If you suspect an overdose, it’s important to seek medical help immediately. Supportive care and treatment for specific symptoms will be necessary, so monitoring your condition closely is crucial. Always consult a healthcare professional if you have concerns about your medication or experience any unusual symptoms.

Pregnancy Use

It is important to be cautious if you are pregnant or planning to become pregnant. The safety of phenylephrine hydrochloride during pregnancy has not been established, and its use is contraindicated, meaning it is not recommended due to potential risks to the fetus. There may be specific risks associated with this medication, so it is essential to consult your healthcare provider for personalized advice and guidance before taking any medication during pregnancy.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

The information provided does not specify any guidelines for using this medication in children. There are no recommended ages, dosage adjustments, or safety precautions outlined for pediatric use (which refers to the treatment of infants, children, and adolescents).

If you are considering this medication for a child, it is important to consult with a healthcare professional to ensure it is safe and appropriate for their specific needs.

Geriatric Use

When it comes to using this medication in older adults, there are no specific guidelines or recommendations regarding age-related dosage adjustments or safety concerns. This means that while the medication can be prescribed to older patients, healthcare providers may not have tailored information to guide them in making decisions about your treatment.

It's always important for you or your caregivers to discuss any concerns with your healthcare provider, especially regarding how this medication may affect you based on your overall health and any other medications you may be taking. Your provider can help ensure that your treatment is safe and effective.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular liver function tests (which check how well your liver is working) to ensure your safety while using any medication.

Drug Interactions

It's great to know that there are no known interactions between this medication and other drugs or laboratory tests. However, it's still very important to discuss all medications you are taking, including over-the-counter drugs and supplements, with your healthcare provider. This ensures that your treatment is safe and effective.

Always keep your healthcare provider informed about any changes in your health or new medications you start. Open communication helps prevent any potential issues and supports your overall well-being.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20°C to 25°C (68°F to 77°F). It's important to keep it protected from light to maintain its effectiveness. Once you open the product, please remember to discard it after use to ensure safety and prevent contamination. Following these guidelines will help you use the product safely and effectively.

Additional Information

You will administer this medication through the eyes (ophthalmic route). There are no additional details available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences. If you have any questions about how to use this medication, be sure to consult your healthcare provider for guidance.

FAQ

What is FRESHCLEAR®?

FRESHCLEAR® is an ophthalmic solution that contains phenylephrine hydrochloride and is available in a sterile formulation.

How should I use FRESHCLEAR®?

You should administer 1 to 2 drops of FRESHCLEAR® into the affected eye(s) as needed.

What are the potential side effects of FRESHCLEAR®?

Possible side effects include burning, stinging, blurred vision, headache, dizziness, and hypersensitivity reactions.

Is FRESHCLEAR® safe to use during pregnancy?

FRESHCLEAR® is contraindicated in pregnancy due to potential risks to the fetus; consult your healthcare provider for guidance.

What should I do if I experience severe side effects?

If you experience severe adverse reactions, including cardiovascular events, seek emergency medical help immediately.

How should I store FRESHCLEAR®?

Store FRESHCLEAR® at 20°C to 25°C (68°F to 77°F) and protect it from light. Discard after opening.

Can I use FRESHCLEAR® if I have cardiovascular disease?

Use FRESHCLEAR® with caution if you have cardiovascular disease, hypertension, or hyperthyroidism.

Packaging Info

The table below lists all NDC Code configurations of Fresh Clear (phenylephrine hydrochloride), the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Fresh Clear.
Details

FDA Insert (PDF)

This is the full prescribing document for Fresh Clear, submitted to the U.S. Food and Drug Administration (FDA). It contains official information for healthcare providers, including how to use the medication, possible side effects, and safety warnings.

View FDA-approved insert (PDF)

Description

FRESHCLEAR® is a sterile solution containing fenilefrina as its active ingredient. The formulation includes 0.12% fenilefrina and 1.4% alcohol polivinílico. It is presented in a 15 mL dropper bottle, manufactured by Allergan.

Uses and Indications

This drug is indicated for use in specific patient populations as determined by clinical guidelines. However, the specific indications and usage details are not explicitly stated in the provided information.

Healthcare professionals are advised to consult relevant clinical resources and guidelines to determine appropriate applications of this drug in practice. There are no documented teratogenic or nonteratogenic effects associated with this drug in the provided data.

Dosage and Administration

The active ingredient phenylephrine hydrochloride is administered as an ophthalmic solution at a strength of 1.2 mg per 1 mL.

For administration, the healthcare professional should instill the prescribed number of drops into the affected eye(s) as directed. It is essential to ensure that the dropper does not come into contact with the eye or any other surface to maintain sterility.

The frequency of administration should be determined based on the clinical condition being treated, and healthcare professionals are advised to follow the specific dosing regimen outlined in the prescribing information.

Contraindications

There are no specific contraindications, controlled substance classifications, or details regarding abuse, misuse, or dependence risks provided in the available data. Therefore, the use of this product is not contraindicated in any particular conditions or situations based on the information at hand.

Warnings and Precautions

Healthcare professionals should be aware that there are no specific warnings or general precautions associated with the use of this medication as per the current data. Additionally, there are no recommended laboratory tests outlined for monitoring purposes.

In the event of any adverse reactions or unexpected symptoms, it is imperative for patients to seek emergency medical assistance. Furthermore, if a patient experiences any concerning side effects, they should discontinue use of the medication and consult their healthcare provider for further guidance.

It is essential for healthcare professionals to remain vigilant and to provide patients with appropriate instructions regarding the management of their treatment and any potential side effects.

Side Effects

Severe adverse reactions may occur, including hypersensitivity reactions such as anaphylaxis. Patients with a history of cardiovascular disease, hypertension, or hyperthyroidism should use this medication with caution due to the potential for serious cardiovascular events.

Common adverse reactions observed in clinical trials and postmarketing experiences include cardiovascular effects such as hypertension, reflex bradycardia, and arrhythmias. Neurological symptoms reported by participants include headache, dizziness, and tremors. Ocular reactions, such as burning, stinging, blurred vision, photophobia, and conjunctival hyperemia, have also been noted.

Dermatologic reactions, including rash and pruritus, are frequently reported. Respiratory symptoms, particularly dyspnea, and gastrointestinal disturbances such as nausea and vomiting, have been documented as well.

Healthcare providers should monitor patients for these adverse reactions and manage them appropriately.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified for this product. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

The table below lists all NDC Code configurations of Fresh Clear (phenylephrine hydrochloride), the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Fresh Clear.
Details

Pediatric Use

Pediatric use is not specifically addressed in the available prescribing information. There are no recommended age ranges, dosing differences, safety concerns, or special precautions for pediatric patients, including infants, children, and adolescents. Healthcare professionals should exercise caution and consider the lack of data when prescribing this medication to pediatric populations.

Geriatric Use

Elderly patients may not have specific recommendations regarding age considerations, dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the potential for altered pharmacokinetics and pharmacodynamics in this population.

Pregnancy

Safety during pregnancy has not been established for this medication. Use is contraindicated in pregnant patients due to potential risks to the fetus. There may be risks associated with the use of phenylephrine hydrochloride during pregnancy; therefore, it is essential for healthcare providers to be consulted for further guidance regarding the use of this medication in women of childbearing potential.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available concerning the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

Overdosage of phenylephrine hydrochloride may result in significant adverse effects that require immediate attention. Healthcare professionals should be vigilant in recognizing the symptoms associated with overdosage, which may include hypertension, bradycardia, and various other cardiovascular complications.

In the event of an overdosage, it is imperative to implement supportive measures promptly. Symptomatic treatment should be initiated to address the specific manifestations of the overdosage. Continuous monitoring of the patient is essential to detect any signs of overdosage, allowing for timely and appropriate management interventions.

Healthcare providers are advised to remain alert to the potential severity of these symptoms and to act swiftly to mitigate the risks associated with phenylephrine hydrochloride overdosage.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the provided data.

Patient Counseling

Patients should be advised to avoid touching the dropper tip to any surface, as this may contaminate the solution and compromise its effectiveness. It is important for patients to use the drops only as directed by their healthcare provider to ensure proper treatment and minimize the risk of complications.

Patients should be informed that if they experience any adverse reactions or notice a worsening of their symptoms, they should contact their healthcare provider immediately for further guidance. Additionally, patients should be advised to keep the medication out of reach of children to prevent accidental ingestion or misuse.

It is crucial to inform patients that the solution is intended for ophthalmic use only and should not be ingested under any circumstances. This information is essential for ensuring the safe and effective use of the medication.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. It should be stored at a temperature range of 20°C to 25°C (68°F to 77°F) to maintain its integrity. It is essential to protect the product from light exposure to prevent degradation. Additionally, once opened, the product must be discarded to ensure safety and efficacy.

Additional Clinical Information

The route of administration for the medication is ophthalmic. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Fresh Clear as submitted by Allergan, Inc.. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Fresh Clear, retrieved by a validated AI data-extraction workflow.

All FDA-approved dosage forms and strengths are listed in the Packaging & NDC Codes section above. Regulatory status, pharmacologic class (EPC), and mechanism of action (MoA) were cross-checked against the FDA Orange Book () and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

Last AI update:

Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.