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Vortex Moisturizer Oral
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This product has been discontinued
- Active ingredient
- Phenol 7 mg/1 mL
- Other brand names
- Dosage form
- Spray
- Route
- Oral
- Prescription status
- OTC (over the counter)
- Pregnancy
- See Pregnancy Use Section
- Lactation
- See Lactation Use Section
- Marketed in the U.S.
- Since 2022
- Label revision date
- March 7, 2022
- Drug Information (PDF)
- Prescribing information, PDF file
- Active ingredient
- Phenol 7 mg/1 mL
- Other brand names
- Dosage form
- Spray
- Route
- Oral
- 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 2022
- Label revision date
- March 7, 2022
- Manufacturer
- Vortex Life Sciences, Inc.
- Registration number
- part356
- NDC root
- 82529-001
- 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
You may be experiencing discomfort from a dry, sore, or irritated throat. This medication is designed to help relieve those symptoms, providing soothing relief to make you feel more comfortable. While the specific mechanism of action isn't detailed, its primary purpose is to alleviate throat irritation, helping you get back to your daily activities with less discomfort.
Uses
If you're dealing with a dry, sore, or irritated throat, this medication can help provide relief. It works by soothing the discomfort and irritation you may be experiencing, making it easier for you to swallow and speak. Whether it's due to a cold, allergies, or other factors, this treatment aims to make you feel more comfortable.
Dosage and Administration
When using this medication, the dosage varies based on age. For adults and children aged 12 and older, you should use 3 sprays. If your child is between 6 and 12 years old, the dosage is 2 sprays. For children aged 3 to 6, you will need to give 1 spray, and for those under 3 years old, it's also 1 spray, but you should consult a physician first.
To administer the medication, start by removing the cap. Then, press down on the pump completely to spray it directly into the mouth and throat. The frequency of administration is important: on the first two days, you will need to spray every 3 hours. On the third day, reduce it to 3 times a day, and then just at bedtime on the fourth and fifth days. You will skip days 6 through 9, and on day 10, you will give the final dose at bedtime. If symptoms are moderate to severe, you can spray every 3 hours, ensuring you have at least 5 doses in a 24-hour period until you notice significant improvement. After that, you can return to the schedule for day 3.
What to Avoid
It's important to be cautious when using this product. If you experience any discomfort while using it, please stop and consult with your physician for guidance. In the event of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-2222. Your safety is a priority, so don't hesitate to reach out for assistance if needed.
Side Effects
If you experience a severe or persistent sore throat, especially if it's accompanied by a high fever, headache, nausea, or vomiting, it's important to consult a doctor immediately, as these symptoms may indicate a serious condition. Additionally, if you are considering this product for a child under 3 years old, please consult a doctor first.
You should stop using this product and seek medical advice if you feel any discomfort while using it. In the event of an overdose, contact a Poison Control Center at 1-800-222-2222 or seek medical help right away.
Warnings and Precautions
It's important to use this product only as directed. If you are pregnant or breastfeeding, please talk to your doctor before using it. Keep the product out of reach of children to ensure their safety.
If you experience any discomfort while using this product, stop using it and consult your physician. Be aware that a severe or persistent sore throat, especially if accompanied by a high fever, headache, nausea, or vomiting, could indicate a serious condition, so seek medical attention immediately. If you suspect an overdose, get medical help or contact a Poison Control Center at 1-800-222-2222 right away. Additionally, consult your doctor before giving this product to children under 3 years old.
Overdose
If you suspect an overdose, it’s crucial to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-2222 for guidance. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.
Always take overdosing seriously. If you notice any of these symptoms or have concerns about your health, don’t hesitate to reach out for help right away. Your safety is the top priority.
Pregnancy Use
If you are pregnant or breastfeeding, it is important to consult with your physician before using this medication. Your healthcare provider can help you understand any potential risks and ensure that you make the safest choices for you and your baby. Always prioritize open communication with your doctor regarding any medications you may be considering during this time.
Lactation Use
If you are pregnant or breastfeeding, it’s important to talk to your doctor before using this medication. Consulting with a healthcare professional can help ensure that you and your baby remain safe and healthy while considering any potential risks associated with the medication. Always prioritize open communication with your physician regarding your breastfeeding journey.
Pediatric Use
When using this medication for children, it's important to follow the recommended dosage based on their age. For children aged 12 years and older, the dosage is 3 sprays. If your child is between 6 and 12 years old, they should receive 2 sprays. For those aged 3 to 6 years, the appropriate dosage is 1 spray.
If your child is under 3 years old, you should only give them 1 spray, but it's crucial to consult a physician (doctor) before administering the medication. Always ensure you follow these guidelines to keep your child safe and healthy.
Geriatric Use
While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s always a good idea to discuss any medications with a healthcare provider. They can help determine the best approach, considering any unique health needs or conditions.
Since there are no dosage adjustments or safety concerns specifically noted for elderly patients, your healthcare provider will guide you on the appropriate use of this medication based on individual health status. Always keep them informed about any other medications or health issues to ensure safe and effective treatment.
Renal Impairment
If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have renal impairment (kidney issues).
Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help monitor your kidney function and make any necessary adjustments to your treatment plan.
Hepatic Impairment
If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication should be used if you have hepatic impairment (issues with liver function).
Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.
Drug Interactions
It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. In this case, there are no known drug interactions or laboratory test interactions associated with the medication. However, every individual is different, and your healthcare provider can help ensure that your treatment is safe and effective for you. Always feel free to ask questions or express any concerns you may have regarding your medications or health tests.
Storage and Handling
To ensure the best use of your product, store and use it at room temperature. Before using, take a moment to inspect the bottle for any signs of damage or integrity issues. If you notice that the safety seal is broken, do not use the product, as this could compromise its safety and effectiveness. Following these simple steps will help you handle the product safely and effectively.
Additional Information
You should take this medication orally. If you are pregnant or breastfeeding, it's important to consult with your doctor before using this product. If you experience any discomfort while using it, stop and talk to your physician. Be aware that a severe or persistent sore throat, especially if accompanied by a high fever, headache, nausea, or vomiting, could indicate a serious condition, so seek medical attention promptly. Additionally, consult a doctor before giving this medication to children under 3 years old.
FAQ
What is the purpose of this drug?
This drug relieves dry, sore, and irritated throat.
What is the dosage for adults and children over 12?
The dosage for adults and children 12 years and older is 3 sprays.
What is the dosage for children aged 6 to 12?
Children aged 6 to 12 should take 2 sprays.
What is the dosage for children aged 3 to 6?
For children aged 3 to 6, the dosage is 1 spray.
What should I do for children under age 3?
For children under age 3, use 1 spray but consult a physician first.
How should I administer the drug?
Remove the cap and depress the pump completely to spray directly into your mouth and throat.
What is the recommended frequency of administration?
On Day 1 and Day 2, use every 3 hours; on Day 3, use 3 times a day; on Days 4 and 5, use at bedtime; skip Days 6-9; and on Day 10, use at bedtime for the final dose.
What should I do if I experience discomfort while using this product?
Stop use and consult with a physician if you experience any discomfort.
What should I do in case of overdose?
Get medical help or contact a Poison Control Center at 1-800-222-2222 right away.
Are there any warnings I should be aware of?
Severe or persistent sore throat, especially with high fever, headache, nausea, or vomiting, may be serious. Consult a doctor right away.
Can I use this drug if I am pregnant or breastfeeding?
Consult with a physician before use if you are pregnant or breastfeeding.
How should I store this drug?
Store and use at room temperature and inspect the bottle for integrity. Do not use if the safety seal is broken.
Packaging Info
Below are the non-prescription pack sizes of Vortex Moisturizer Oral (phenol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Spray | 7 mg/1 mL | ||
Product details Regulatory status — Discontinued NSDE (NDC Directory) reports this NDC as Not Marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
Drug Information (PDF)
This file contains official product information for Vortex Moisturizer Oral, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.
Description
The drug is identified by SPL code 34089-3. It is presented as a white to off-white, round, biconvex tablet, which is debossed with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. The formulation includes inactive ingredients such as lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate.
Uses and Indications
This drug is indicated for the relief of dry, sore, and irritated throat. It is intended for use in patients experiencing these symptoms, providing symptomatic relief to enhance comfort.
Dosage and Administration
For individuals aged 12 years and older, the recommended dosage is 3 sprays. For children aged 6 to 12 years, the dosage is 2 sprays, while for those aged 3 to 6 years, the dosage is 1 spray. In children under the age of 3, 1 spray is advised, but consultation with a physician is required prior to administration.
The administration method involves removing the cap and fully depressing the pump to spray directly into the mouth and throat.
The frequency of administration is as follows:
Day 1: Administer every 3 hours.
Day 2: Administer every 3 hours.
Day 3: Administer 3 times a day.
Day 4: Administer at bedtime.
Day 5: Administer at bedtime.
Days 6 to 9: No doses should be administered.
Day 10: Administer at bedtime for the final dose.
For patients experiencing moderate to severe symptoms, the medication may be administered every 3 hours, ensuring a minimum of 5 doses within a 24-hour period until symptoms have significantly reduced. Following this, the dosing schedule should revert to the regimen outlined for Day 3.
Contraindications
There are no specific contraindications identified for this product. However, it is advised to discontinue use and consult a physician if any discomfort occurs during use. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-2222.
Warnings and Precautions
Use of this product should be strictly in accordance with the provided directions. Healthcare professionals are advised to counsel patients to consult with a physician prior to use if they are pregnant or breastfeeding. It is imperative to keep this product out of the reach of children to prevent accidental ingestion or misuse.
Patients should be instructed to discontinue use and seek medical advice if they experience any discomfort while using the product. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center contacted at 1-800-222-2222.
Healthcare providers should be vigilant for signs of severe or persistent sore throat, particularly when accompanied by high fever, headache, nausea, or vomiting, as these symptoms may indicate a serious condition requiring prompt medical evaluation. Additionally, it is recommended that a physician be consulted before administering this product to children under the age of three.
Side Effects
Patients may experience a range of adverse reactions while using this product. Serious reactions include severe or persistent sore throat, particularly when accompanied by high fever, headache, nausea, or vomiting. Such symptoms may indicate a serious condition, and patients are advised to consult a physician immediately if they occur.
Additionally, patients should stop using the product and seek medical advice if they experience any discomfort during use. In the event of an overdose, it is crucial to obtain medical assistance or contact a Poison Control Center at 1-800-222-2222 without delay.
It is recommended that caregivers consult a physician before administering this product to children under the age of 3, particularly in the context of sore throat symptoms.
Drug Interactions
There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.
Packaging & NDC
Below are the non-prescription pack sizes of Vortex Moisturizer Oral (phenol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Spray | 7 mg/1 mL | ||
Product details Regulatory status — Discontinued NSDE (NDC Directory) reports this NDC as Not Marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
Pediatric Use
Pediatric patients aged 12 years and older may receive a dosage of 3 sprays. For those between 6 and 12 years old, the recommended dosage is 2 sprays. Children aged 3 to 6 years should be administered 1 spray, while infants and children under the age of 3 are also advised to receive 1 spray, but it is essential to consult a physician before administration in this age group.
Geriatric Use
There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. 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
Pregnant patients and those who are breastfeeding should consult with a physician prior to using this medication. The potential risks and benefits must be carefully evaluated in these populations to ensure maternal and fetal safety.
Lactation
Lactating mothers are advised to consult with a physician prior to using this medication. There is currently no available data regarding the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, healthcare professionals should consider the potential risks and benefits when recommending this medication to lactating patients.
Renal Impairment
Patients with renal impairment have not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.
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 prescribing information.
Overdosage
In the event of an overdose, it is imperative to seek immediate medical assistance. Healthcare professionals are advised to contact a Poison Control Center at 1-800-222-2222 for guidance on managing the situation effectively.
Prompt intervention is crucial in mitigating potential adverse effects associated with overdose. Symptoms may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms as they arise.
Management procedures may include supportive care and symptomatic treatment, tailored to the specific clinical presentation of the patient. Continuous monitoring and evaluation are essential to ensure patient safety and to address any complications that may develop during the course of treatment.
Nonclinical Toxicology
If pregnant or breastfeeding, it is advised to consult with a physician before use due to potential teratogenic effects. No non-teratogenic effects have been provided in the available data. Additionally, there is no information regarding animal pharmacology and toxicology.
Postmarketing Experience
No postmarketing experience details are available in the insert text.
Patient Counseling
Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion or misuse. It is important for patients to be informed that they should stop using the product and consult with a physician if they experience any discomfort during use. Additionally, in the event of an overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center at 1-800-222-2222 for assistance.
Storage and Handling
The product is supplied in a container that should be inspected for integrity prior to use. It must not be used if the safety seal is broken. The product should be stored and utilized at room temperature to ensure optimal quality and efficacy.
Additional Clinical Information
The product is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult with a physician prior to use. Patients are also instructed to discontinue use and seek medical advice if they experience any discomfort while using the product. Additionally, severe or persistent sore throat, particularly when accompanied by high fever, headache, nausea, or vomiting, may indicate a serious condition, warranting immediate consultation with a healthcare provider. It is recommended that a doctor be consulted before administering the product to children under the age of three.
Drug Information (PDF)
This file contains official product information for Vortex Moisturizer Oral, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.