Refresh Optive Mega-3

Last content change Jun 30, 2022checked dailysee data sync status

Active ingredients: Glycerin 10 mg/1 mL
Carboxymethylcellulose Sodium 5 mg/1 mL
Polysorbate 80 5 mg/1 mL
Other brand names: Droptics Dry Eye Relief (by Droptics Llc)
Refresh Digital (by Allergan, Inc.)
Refresh Digital Pf (by Allergan, Inc.)
Refresh Optive Advanced (by Allergan, Inc.)
Refresh Optive Advanced (by Allergan, Inc.)
View full label-group details →
Drug class: Non-Standardized Chemical Allergen
Dosage form: Solution/ Drops
Route: Ophthalmic
Prescription status: OTC (over the counter)
Pregnancy: See Pregnancy Use Section
Lactation: See Lactation Use Section
Marketed in the U.S.: Since 2017
Label revision date: June 30, 2022
Drug Information (PDF): Prescribing information, PDF file

Active ingredients: Glycerin 10 mg/1 mL
Carboxymethylcellulose Sodium 5 mg/1 mL
Polysorbate 80 5 mg/1 mL
Other brand names: Droptics Dry Eye Relief (by Droptics Llc)
Refresh Digital (by Allergan, Inc.)
Refresh Digital Pf (by Allergan, Inc.)
Refresh Optive Advanced (by Allergan, Inc.)
Refresh Optive Advanced (by Allergan, Inc.)
View full label-group details →
Drug class: Non-Standardized Chemical Allergen
Dosage form: Solution/ Drops
Route: Ophthalmic
Prescription status: OTC (over the counter)
CSA schedule: Not a scheduled drug
Pregnancy: See Pregnancy Use Section
Lactation: See Lactation Use Section
Marketed in the U.S.: Since 2017
Label revision date: June 30, 2022
Manufacturer: Allergan, Inc.
Registration number: M018
NDC roots: 0023-4230, 0023-5773, 0023-7151
Drug Information (PDF): Prescribing information, PDF file

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

Refresh OPTIVE MEGA-3® is a type of lubricant eye drop designed to provide temporary relief from burning, irritation, and discomfort caused by dry eyes or exposure to wind and sun. These eye drops are enhanced with flaxseed oil, which helps to soothe and protect your eyes from further irritation.

The product is preservative-free and comes in convenient vials, making it easy to use whenever you need relief. Whether you're dealing with dry eyes due to environmental factors or just need a little extra comfort, Refresh OPTIVE MEGA-3® can help keep your eyes feeling better.

Uses

If you're experiencing burning, irritation, or discomfort in your eyes due to dryness or exposure to wind or sun, this product can provide temporary relief. It works by soothing your eyes and helping to alleviate those uncomfortable sensations.

Additionally, it may serve as a protective barrier against further irritation, ensuring your eyes stay comfortable in challenging conditions. You can use it to help maintain eye comfort throughout the day.

Dosage and Administration

To use this eye medication, you should instill 1 or 2 drops directly into the affected eye or eyes whenever you feel it's necessary. After using the drops, make sure to discard the container to ensure safety and hygiene. It's important to follow this guideline to help manage your eye condition effectively.

What to Avoid

It's important to be aware of certain situations when using this medication. If you experience any eye pain, changes in your vision, ongoing redness or irritation of the eye, or if your condition worsens or does not improve after 72 hours, you should stop using the product and consult your doctor immediately.

Currently, there are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this medication. However, always prioritize your health and safety by following these guidelines.

Side Effects

You should be aware that this product is for external use only. To prevent contamination, avoid touching the tip of the container to any surface, and do not reuse it once opened—discard it instead. If the solution changes color, do not use it.

If you experience eye pain, changes in vision, ongoing redness or irritation, or if your condition worsens or does not improve after 72 hours, stop using the product and consult a doctor. Additionally, keep this product out of reach of children. If swallowed, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

This product is for external use only, so please avoid applying it to any internal areas. To keep the solution clean, do not let the tip of the container touch any surfaces, and do not reuse it once opened—just discard it. Be careful not to touch the unit-dose tip to your eye, and if you notice any change in the solution's color, do not use it.

If you experience eye pain, changes in your vision, ongoing redness or irritation, or if your condition worsens or does not improve after 72 hours, stop using the product and contact your doctor. Always keep this product out of reach of children. If it is swallowed, seek medical help or contact a Poison Control Center immediately.

Overdose

If you or someone else has swallowed too much of a medication, it's important to act quickly. You should seek medical help immediately or contact a Poison Control Center. They can provide guidance on what to do next.

Signs of an overdose can vary, but they may include unusual symptoms or changes in behavior. If you notice anything concerning, don’t hesitate to reach out for help. Remember, it's always better to be safe and get professional advice in these situations.

Pregnancy Use

The safety of REFRESH OPTIVE MEGA-3 during pregnancy has not been established, meaning there is limited information on how it may affect you or your developing baby. Currently, there are no adequate and well-controlled studies in pregnant women to assess its safety. Because of this uncertainty, it is advised to use this product only if the potential benefits outweigh any possible risks to your fetus.

If you are pregnant or planning to become pregnant, it's important to discuss any medications or supplements with your healthcare provider. They can help you weigh the potential benefits against the risks and determine the best course of action for your health and the health of your baby.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to talk to your healthcare professional before using this product. There is a possibility that the ingredients could pass into your breast milk, so caution is advised.

Additionally, the effects on your nursing infant have not been thoroughly studied. Therefore, it's essential to weigh the potential risks against the benefits of using this product while breastfeeding. Your healthcare provider can help you make an informed decision that prioritizes both your health and your baby's well-being.

Pediatric Use

It's important to keep this medication out of reach of children to prevent accidental ingestion. If your child swallows any of it, seek medical help immediately or contact a Poison Control Center for guidance. Taking these precautions can help ensure your child's safety.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult, it’s important to consult with a healthcare provider before starting the medication. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment is safe and effective for your specific condition. They can help determine the best approach for managing your health, especially if you have concerns about your kidneys.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help you understand how to manage your health while taking any medications.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your full list of medications and any lab tests you undergo, as this helps in managing your health effectively.

Storage and Handling

To ensure the safety and effectiveness of your product, always use it only if the single-use container is intact and has not been damaged. Be sure to check the expiration date marked on the container and use the product before that date.

For proper storage, keep the vials in their pouch until you are ready to use them, and store them at a temperature between 59°F and 77°F (15°C to 25°C). Following these guidelines will help maintain the quality and safety of the product.

Additional Information

No further information is available.

FAQ

What is Refresh OPTIVE MEGA-3®?

Refresh OPTIVE MEGA-3® is a lubricant eye drop enhanced with HydroCell® and flaxseed oil, designed for the temporary relief of burning, irritation, and discomfort due to dryness of the eye.

How do I use Refresh OPTIVE MEGA-3®?

Instill 1 or 2 drops in the affected eye(s) as needed and discard the container after use.

Are there any contraindications for using Refresh OPTIVE MEGA-3®?

No contraindications are listed for this product.

What should I do if I experience eye pain or changes in vision while using this product?

Stop use and ask a doctor if you experience eye pain, changes in vision, continued redness or irritation, or if the condition worsens or persists for more than 72 hours.

Is Refresh OPTIVE MEGA-3® safe to use during pregnancy?

The safety of Refresh OPTIVE MEGA-3® during pregnancy has not been established, and it should only be used if the potential benefit justifies the potential risk to the fetus.

Can nursing mothers use Refresh OPTIVE MEGA-3®?

Nursing mothers should consult a healthcare professional before using this product, as there is a potential for excretion in breast milk.

What are the storage instructions for Refresh OPTIVE MEGA-3®?

Store the vials at 59°-77°F (15°-25°C) and keep them in the pouch until use. Use only if the single-use container is intact and before the expiration date.

What should I do if the solution changes color?

If the solution changes color, do not use it.

What are the side effects of Refresh OPTIVE MEGA-3®?

For external use only, and to avoid contamination, do not touch the tip of the container to any surface. If swallowed, get medical help or contact a Poison Control Center right away.

Packaging Info

Below are the non-prescription pack sizes of Refresh Optive Mega-3 (carboxymethylcellulose sodium, glycerin and polysorbate 80). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Refresh Optive Mega-3.

	70 in box 0.4 mL in vial, single-use 70 items total	Solution/ Drops	Carboxymethylcellulose Sodium 5 mg/1 mL Glycerin 10 mg/1 mL Polysorbate 80 5 mg/1 mL
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC: NSDE file: February 16, 2026 → status: Active (as of July 1, 2024) Type Type 0: Not a Combination Product Active ingredients Carboxymethylcellulose Sodium 5 mg/1 mL Glycerin 10 mg/1 mL Polysorbate 80 5 mg/1 mL Inactive ingredients boric acid butylated hydroxytoluene carbomer copolymer type a (allyl pentaerythritol crosslinked) castor oil erythritol linseed oil levocarnitine polyoxyl stearate 40 water trehalose sodium hydroxide hydrochloric acid
	5 in box 0.4 mL in vial, single-use 5 items total	Solution/ Drops	Carboxymethylcellulose Sodium 5 mg/1 mL Glycerin 10 mg/1 mL Polysorbate 80 5 mg/1 mL
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC: NSDE file: February 16, 2026 → status: Active (as of May 30, 2017) Type Type 0: Not a Combination Product Active ingredients Carboxymethylcellulose Sodium 5 mg/1 mL Glycerin 10 mg/1 mL Polysorbate 80 5 mg/1 mL Inactive ingredients boric acid butylated hydroxytoluene carbomer copolymer type a (allyl pentaerythritol crosslinked) castor oil erythritol linseed oil levocarnitine polyoxyl stearate 40 water trehalose sodium hydroxide hydrochloric acid
	30 in box 0.4 mL in vial, single-use 30 items total	Solution/ Drops	Carboxymethylcellulose Sodium 5 mg/1 mL Glycerin 10 mg/1 mL Polysorbate 80 5 mg/1 mL
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC: NSDE file: February 16, 2026 → status: Active (as of May 30, 2017) Type Type 0: Not a Combination Product Active ingredients Carboxymethylcellulose Sodium 5 mg/1 mL Glycerin 10 mg/1 mL Polysorbate 80 5 mg/1 mL Inactive ingredients boric acid butylated hydroxytoluene carbomer copolymer type a (allyl pentaerythritol crosslinked) castor oil erythritol linseed oil levocarnitine polyoxyl stearate 40 water trehalose sodium hydroxide hydrochloric acid
	60 in box 0.4 mL in vial, single-use 60 items total	Solution/ Drops	Carboxymethylcellulose Sodium 5 mg/1 mL Glycerin 10 mg/1 mL Polysorbate 80 5 mg/1 mL
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC: NSDE file: February 16, 2026 → status: Active (as of June 15, 2021) Type Type 0: Not a Combination Product Active ingredients Carboxymethylcellulose Sodium 5 mg/1 mL Glycerin 10 mg/1 mL Polysorbate 80 5 mg/1 mL Inactive ingredients boric acid butylated hydroxytoluene carbomer copolymer type a (allyl pentaerythritol crosslinked) castor oil erythritol linseed oil levocarnitine polyoxyl stearate 40 water trehalose sodium hydroxide hydrochloric acid

Drug Information (PDF)

This file contains official product information for Refresh Optive Mega-3, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

NDC 0023-5773-30. Refresh OPTIVE MEGA-3® is a preservative-free formulation of lubricant eye drops designed to provide fast-acting relief for dry eye symptoms. Each vial contains HydroCell® technology, which enhances the moisture retention of the eye surface. The formulation is enriched with flaxseed oil, contributing to its efficacy in alleviating dryness. The product is supplied in a sterile format, with 30 vials, each containing 0.01 fl oz (0.4 mL) of solution.

Uses and Indications

This drug is indicated for the temporary relief of burning, irritation, and discomfort associated with dryness of the eye or exposure to wind or sun. It may also be utilized as a protectant against further irritation.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Healthcare professionals are advised to instill 1 or 2 drops of the medication into the affected eye(s) as needed. After use, the container should be discarded to ensure proper hygiene and prevent contamination.

Contraindications

There are no specific contraindications listed for this product. However, it is advised to discontinue use and consult a healthcare professional if the patient experiences eye pain, changes in vision, persistent redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours.

Warnings and Precautions

For external use only. To prevent contamination, it is imperative that the tip of the container not be touched to any surface. The container is intended for single use; once opened, it should be discarded and not reused.

Care should be taken to avoid contact between the unit-dose tip and the eye. If the solution exhibits any change in color, it must not be used.

Healthcare professionals should advise patients to discontinue use and seek medical attention if they experience any of the following: eye pain, changes in vision, persistent redness or irritation of the eye, or if the condition worsens or does not improve within 72 hours.

This product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions. This product is intended for external use only. To prevent contamination, patients are advised not to touch the tip of the container to any surface and to avoid reusing the container. If the solution changes color, it should not be used.

Patients should discontinue use and consult a doctor if they experience any of the following symptoms: eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours.

Additionally, this product should be kept out of reach of children. In the event of accidental ingestion, it is crucial to seek medical help or contact a Poison Control Center immediately.

Drug Interactions

There are currently no specific drug interactions identified for the medication. Additionally, no interactions with laboratory tests have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time. It is advisable for healthcare professionals to remain vigilant and consult updated resources as new data may emerge.

Packaging & NDC

Packaging configurations for Refresh Optive Mega-3.

	70 in box 0.4 mL in vial, single-use 70 items total	Solution/ Drops	Carboxymethylcellulose Sodium 5 mg/1 mL Glycerin 10 mg/1 mL Polysorbate 80 5 mg/1 mL
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC: NSDE file: February 16, 2026 → status: Active (as of July 1, 2024) Type Type 0: Not a Combination Product Active ingredients Carboxymethylcellulose Sodium 5 mg/1 mL Glycerin 10 mg/1 mL Polysorbate 80 5 mg/1 mL Inactive ingredients boric acid butylated hydroxytoluene carbomer copolymer type a (allyl pentaerythritol crosslinked) castor oil erythritol linseed oil levocarnitine polyoxyl stearate 40 water trehalose sodium hydroxide hydrochloric acid
	5 in box 0.4 mL in vial, single-use 5 items total	Solution/ Drops	Carboxymethylcellulose Sodium 5 mg/1 mL Glycerin 10 mg/1 mL Polysorbate 80 5 mg/1 mL
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC: NSDE file: February 16, 2026 → status: Active (as of May 30, 2017) Type Type 0: Not a Combination Product Active ingredients Carboxymethylcellulose Sodium 5 mg/1 mL Glycerin 10 mg/1 mL Polysorbate 80 5 mg/1 mL Inactive ingredients boric acid butylated hydroxytoluene carbomer copolymer type a (allyl pentaerythritol crosslinked) castor oil erythritol linseed oil levocarnitine polyoxyl stearate 40 water trehalose sodium hydroxide hydrochloric acid
	30 in box 0.4 mL in vial, single-use 30 items total	Solution/ Drops	Carboxymethylcellulose Sodium 5 mg/1 mL Glycerin 10 mg/1 mL Polysorbate 80 5 mg/1 mL
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC: NSDE file: February 16, 2026 → status: Active (as of May 30, 2017) Type Type 0: Not a Combination Product Active ingredients Carboxymethylcellulose Sodium 5 mg/1 mL Glycerin 10 mg/1 mL Polysorbate 80 5 mg/1 mL Inactive ingredients boric acid butylated hydroxytoluene carbomer copolymer type a (allyl pentaerythritol crosslinked) castor oil erythritol linseed oil levocarnitine polyoxyl stearate 40 water trehalose sodium hydroxide hydrochloric acid
	60 in box 0.4 mL in vial, single-use 60 items total	Solution/ Drops	Carboxymethylcellulose Sodium 5 mg/1 mL Glycerin 10 mg/1 mL Polysorbate 80 5 mg/1 mL
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC: NSDE file: February 16, 2026 → status: Active (as of June 15, 2021) Type Type 0: Not a Combination Product Active ingredients Carboxymethylcellulose Sodium 5 mg/1 mL Glycerin 10 mg/1 mL Polysorbate 80 5 mg/1 mL Inactive ingredients boric acid butylated hydroxytoluene carbomer copolymer type a (allyl pentaerythritol crosslinked) castor oil erythritol linseed oil levocarnitine polyoxyl stearate 40 water trehalose sodium hydroxide hydrochloric acid

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including 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 efficacy, given the lack of targeted data for this population.

Pregnancy

The safety of REFRESH OPTIVE MEGA-3 during pregnancy has not been established. There are no adequate and well-controlled studies in pregnant women to assess the potential risks to the fetus. Therefore, it is recommended that this product be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. No specific dosage modifications are provided for use during pregnancy. Healthcare professionals should carefully consider the individual circumstances of pregnant patients when recommending this product.

Lactation

Nursing mothers should consult a healthcare professional before using this product. There is a potential for excretion in breast milk; therefore, caution should be exercised when administering to lactating mothers. The effects on the nursing infant are not well studied, and thus, the risks versus benefits should be carefully considered.

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 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

In the event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. It is imperative that healthcare providers remain vigilant and prepared to address any complications that may arise from an overdosage scenario.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. Instruct patients that if the medication is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Additionally, healthcare providers should inform patients to discontinue use and consult a doctor if they experience any of the following symptoms: eye pain, changes in vision, persistent redness or irritation of the eye, or if their condition worsens or does not improve after 72 hours. This guidance is essential to ensure patient safety and effective management of their condition.

Storage and Handling

The product is supplied in single-use containers, which must remain intact for safe usage. It is essential to utilize the product before the expiration date indicated on the container.

For optimal storage conditions, the product should be maintained at a temperature range of 59° to 77°F (15° to 25°C). Vials should be kept in their pouches until they are ready for use to ensure their integrity and effectiveness.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Refresh Optive Mega-3, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (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 Refresh Optive Mega-3, retrieved February 17, 2026 by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory 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: February 17, 2026

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.