ADD CONDITION
Sore Throat
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This product has been discontinued
- Active ingredient
- Phenol 1.4 g/100 mL
- Other brand names
- Cepastat (by Insight Pharmaceuticals)
- Eos Medicated Pain Relieving Lip Balm (by Eos Products Llc)
- Pain Relieving (by J. R. Watkins, Llc.)
- Phenol (by Purinepharma Llc)
- Phylorinol (by Schaffer Laboratories)
- Sore Throat Cherry (by Major Pharmaceuticals)
- Vortex Moisturizer Oral (by Vortex Life Sciences, Inc.)
- View full label-group details →
- 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 2016
- Label revision date
- September 23, 2016
- Drug Information (PDF)
- Prescribing information, PDF file
- Active ingredient
- Phenol 1.4 g/100 mL
- Other brand names
- Cepastat (by Insight Pharmaceuticals)
- Eos Medicated Pain Relieving Lip Balm (by Eos Products Llc)
- Pain Relieving (by J. R. Watkins, Llc.)
- Phenol (by Purinepharma Llc)
- Phylorinol (by Schaffer Laboratories)
- Sore Throat Cherry (by Major Pharmaceuticals)
- Vortex Moisturizer Oral (by Vortex Life Sciences, Inc.)
- View full label-group details →
- 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 2016
- Label revision date
- September 23, 2016
- Manufacturer
- We Care Distributor Inc.
- Registration number
- part356
- NDC root
- 70005-035
- 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
This product is a fast-acting sore throat spray designed to provide temporary relief from occasional minor throat irritation, pain, sore mouth, and sore throat. It contains phenol (an oral anesthetic) and has a pleasant cherry flavor, making it easier to use.
The spray works similarly to Chloraseptic, targeting throat-related discomforts to help soothe your symptoms quickly. If you're experiencing a sore throat, this product may offer you the relief you need.
Uses
If you're experiencing occasional minor throat irritation, pain, or soreness, this medication can provide temporary relief. It's designed to help soothe your throat and alleviate discomfort, making it easier for you to go about your day. Whether you're dealing with a sore mouth or a sore throat, this product can help ease those bothersome symptoms.
Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication, so you can use it with confidence.
Dosage and Administration
To use this medication, start by preparing the bottle. Before your first use, take off the protective neck band and the dust cap from the tip. When you're ready to spray, hold the bottle straight up and press down on the nozzle with your index finger, making sure not to tilt your head. You should fully depress the pump with a firm, even stroke, and remember to wipe the nozzle dry after each use.
For adults and children aged 3 years and older, apply one spray to the affected area. After spraying, let it sit for at least 15 seconds before spitting it out. You can use this medication every 2 hours, or follow your doctor or dentist's instructions. If you're using it for a child under 12, make sure they are supervised. For children under 3 years old, it's important to consult a doctor or dentist before use.
What to Avoid
It's important to use this medication responsibly to ensure your safety and well-being. You should never exceed the recommended dose or use it for more than two days. Always follow the directions provided. Additionally, sharing this medication with others can lead to the spread of infection, so please keep it to yourself. By adhering to these guidelines, you can help prevent any potential issues.
Side Effects
You should be aware that if you experience a severe or persistent sore throat, especially if it's accompanied by a high fever, headache, nausea, or vomiting, it could be serious. It's important to consult your doctor promptly in such cases. Additionally, you should not use this medication for more than two days or give it to children under three years old unless directed by a doctor.
If your sore mouth symptoms do not improve within seven days, or if you notice any irritation, pain, or redness that persists or worsens, you should stop using the medication and consult your doctor or dentist. Also, seek medical advice if you develop swelling, a rash, or a fever.
Warnings and Precautions
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 your doctor right away. You should not use this medication for more than 2 days or give it to children under 3 years old unless directed by a healthcare professional. Always follow the recommended dosage and avoid sharing the container with others to prevent spreading infection.
If your sore mouth symptoms do not improve within 7 days, or if you notice any irritation, pain, or redness that persists or worsens, you should stop using the medication and call your doctor. Additionally, if you develop swelling, a rash, or a fever, seek medical advice. In the event of an overdose or accidental poisoning, get emergency medical help or contact a Poison Control Center immediately.
Overdose
If you suspect an overdose or accidental poisoning, it’s crucial to seek medical help immediately or contact a Poison Control Center. Signs of an overdose can vary, but they may include unusual symptoms that are not typical for you.
Don’t wait for symptoms to worsen; acting quickly can make a significant difference in your health. Always prioritize your safety and well-being by reaching out for professional assistance in these situations.
Pregnancy Use
If you are pregnant or breastfeeding, it’s important to consult your doctor 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 consult your doctor before using this medication. Your healthcare provider can help you understand any potential risks and ensure that you and your baby remain safe while breastfeeding. Always prioritize open communication with your doctor regarding any medications you may consider during this time.
Pediatric Use
It’s important to be cautious when using this product for children. You should not use it in children under 3 years of age unless a doctor has specifically directed you to do so. For children aged 3 years and older, you can apply one spray to the affected area every 2 hours, or as advised by a doctor or dentist.
If your child is under 12 years old, make sure they are supervised while using this product. Always consult a doctor or dentist before using it for children under 3 years to ensure their safety.
Geriatric Use
While there is no specific information about the use of this medication in older adults, it’s important to remember that each person is unique. 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 ensure that the treatment is safe and appropriate for individual health needs, even in the absence of specific guidelines for elderly patients.
Since there are no recommended dosage adjustments or special precautions mentioned for older adults, staying in close communication with your healthcare team can help monitor any potential side effects or changes in health.
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 (liver issues).
Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help you understand how to manage your treatment effectively.
Drug Interactions
It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no known drug interactions or laboratory test interactions associated with them. This ensures that your treatment plan is safe and effective for your individual health needs.
Always feel free to ask questions and share your complete list of medications and any tests you may undergo. Your healthcare provider can help you understand how to manage your health effectively.
Storage and Handling
To ensure the best use of your product, store it at room temperature. Before using it, always check the expiration date to confirm that it is still safe and effective. It's also a good idea to keep the original carton, as it contains important information that you may need to refer to later.
By following these simple storage and handling guidelines, you can help maintain the product's quality and safety for your use.
Additional Information
You should take this medication orally, typically every 2 hours or as directed by your doctor or dentist. If you are pregnant or breastfeeding, it's important to consult your doctor before using this product. Additionally, if you have children under 12, make sure they are supervised while using it. For children under 3 years old, you should consult a doctor or dentist before use.
FAQ
What is the purpose of this throat spray?
This throat spray provides temporary relief from occasional minor throat irritation, pain, sore mouth, and sore throat.
How should I use this throat spray?
For adults and children 3 years and older, apply one spray to the affected area every 2 hours or as directed by a doctor or dentist. Allow the spray to remain in place for at least 15 seconds before spitting it out.
Are there any age restrictions for using this product?
Children under 3 years of age should consult a doctor or dentist before use, and children under 12 should be supervised while using the product.
What should I do if my symptoms do not improve?
If sore mouth symptoms do not improve in 7 days, or if irritation, pain, or redness persists or worsens, consult your doctor or dentist.
Are there any warnings I should be aware of?
Yes, do not use for more than 2 days, and consult a doctor if you experience severe or persistent sore throat, especially if accompanied by high fever, headache, nausea, or vomiting.
Can I use this product if I am pregnant or breastfeeding?
If you are pregnant or breastfeeding, you should ask your doctor before using this product.
What should I do in case of overdose?
In case of overdose or accidental poisoning, seek medical help or contact a Poison Control Center immediately.
How should I store this throat spray?
Store the throat spray at room temperature and check the expiration date before use.
Packaging Info
Below are the non-prescription pack sizes of Sore Throat (phenol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Spray | 1.4 g/100 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 Sore Throat, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.
Description
This formulation contains phenol, an oral anesthetic, which is comparable to the active ingredient found in Chloraseptic. It is designed as a sore throat spray that provides fast relief from throat discomfort. The product is characterized by its instant-acting properties and is available in a cherry flavor, enhancing patient acceptability while delivering effective sore throat relief.
Uses and Indications
This drug is indicated for the temporary relief of occasional minor throat irritation, minor throat pain, sore mouth, and sore throat.
There are no teratogenic or nonteratogenic effects associated with this drug.
Dosage and Administration
Adults and children aged 3 years and older should apply one spray to the affected area. The spray must be allowed to remain in place for a minimum of 15 seconds before being expectorated. This application may be repeated every 2 hours or as directed by a healthcare professional.
Children under 12 years of age should be supervised during the use of this product to ensure proper administration. For children under 3 years of age, it is recommended to consult a doctor or dentist prior to use.
Before the initial application, the protective neck band and dust cap must be removed from the tip of the bottle. To administer the spray, the bottle should be held upright, and the nozzle should be pressed with the index finger without tilting the head. The pump should be fully depressed with a firm, even stroke, and the nozzle should be wiped dry after use.
Contraindications
Use of this product is contraindicated in the following situations:
Exceeding the recommended dose is contraindicated due to the potential for adverse effects.
Prolonged use beyond 2 days is contraindicated; the product should only be used as directed to avoid complications.
Sharing this container among multiple individuals is contraindicated as it may facilitate the spread of infection.
Warnings and Precautions
Severe or persistent sore throat, particularly when accompanied by high fever, headache, nausea, and vomiting, may indicate a serious condition. In such cases, it is imperative to consult a healthcare professional promptly. This product should not be used for more than 2 days, and it is contraindicated for children under 3 years of age unless specifically directed by a physician.
General precautions must be observed to ensure safe use. The recommended dosage should not be exceeded, and the product should only be used as directed. It is important to note that sharing this container among multiple individuals may facilitate the spread of infection.
Healthcare professionals should advise patients to discontinue use and seek medical attention if sore mouth symptoms do not improve within 7 days. Additionally, if irritation, pain, or redness persists or worsens, or if any swelling, rash, or fever develops, patients should contact their doctor immediately.
In the event of an overdose or accidental poisoning, it is crucial to obtain emergency medical assistance or contact a Poison Control Center without delay.
Side Effects
Patients may experience a range of adverse reactions associated with the use of this medication. Serious adverse reactions include severe or persistent sore throat, particularly when accompanied by high fever, headache, nausea, and vomiting. Such symptoms may indicate a serious condition, and patients are advised to consult a healthcare professional promptly.
It is important to note that the medication should not be used for more than 2 days or administered to children under 3 years of age unless directed by a doctor.
Patients should also discontinue use and seek medical advice if sore mouth symptoms do not improve within 7 days. Additional concerns warranting medical consultation include persistent or worsening irritation, pain, or redness, as well as the development of swelling, rash, or fever. These reactions should be monitored closely to ensure patient safety and appropriate management.
Drug Interactions
No specific drug interactions have been identified for this medication. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.
Packaging & NDC
Below are the non-prescription pack sizes of Sore Throat (phenol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Spray | 1.4 g/100 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 under 3 years of age should not use this product unless directed by a doctor. For children aged 3 years and older, the recommended dosage is one spray applied to the affected area every 2 hours, or as directed by a doctor or dentist.
It is advised that children under 12 years of age be supervised during the use of this product to ensure safety and proper application. For any pediatric patient under 3 years, consultation with a doctor or dentist is necessary prior to use.
Geriatric Use
Elderly patients may not have specific information regarding the use of this medication, as the prescribing information does not provide any recommendations or considerations for this population. There are no indicated dosage adjustments, safety concerns, or special precautions that are specifically outlined for geriatric patients.
Healthcare providers should exercise clinical judgment when prescribing this medication to elderly patients, considering the absence of data and the potential for variability in response due to age-related factors. Monitoring for efficacy and safety is advised, as individual patient characteristics may influence treatment outcomes.
Pregnancy
Pregnant patients and those who are breastfeeding should consult their healthcare provider prior to using this medication. It is important to assess the potential risks and benefits associated with the use of this drug during pregnancy and lactation. The healthcare provider can provide guidance based on individual circumstances and the latest clinical data.
Lactation
Lactating mothers are advised to consult their healthcare provider 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, caution is recommended when administering this medication to lactating individuals.
Renal Impairment
Patients with renal impairment have not been specifically addressed in the drug insert text 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 there is no available data to guide dosing or monitoring in this 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 prescribing information.
Overdosage
In the event of an overdose or accidental poisoning, it is imperative to seek immediate medical assistance or contact a Poison Control Center. Prompt action is crucial to mitigate potential adverse effects associated with overdosage.
Healthcare professionals should be aware that symptoms of overdosage may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential for appropriate management.
Management procedures may include supportive care and symptomatic treatment, tailored to the specific symptoms presented. Continuous monitoring of the patient's vital signs and clinical status is recommended to ensure timely intervention if complications arise.
In all cases of suspected overdosage, the involvement of poison control experts can provide valuable guidance on the most effective treatment strategies.
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 limits the assessment of potential risks associated with the use of the compound in these contexts.
Postmarketing Experience
No postmarketing experience details are available in the insert text.
Patient Counseling
Patients should be advised to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose or accidental poisoning. It is important for patients to understand that if symptoms of a sore mouth do not improve within 7 days, they should stop using the product and consult a doctor or dentist.
Healthcare providers should instruct patients to discontinue use and seek medical advice if they experience any irritation, pain, or redness that persists or worsens. Additionally, patients should be informed to stop using the product and consult a healthcare professional if they develop swelling, a rash, or fever.
Patients must be reminded not to exceed the recommended dose while using this product. They should also be cautioned against using the product for more than 2 days and to follow the directions provided. Furthermore, it is essential to inform patients that sharing this container with others may lead to the spread of infection.
Storage and Handling
The product is supplied in a carton that should be retained for future reference. It is essential to store the product at room temperature. Healthcare professionals are advised to check the expiration date before using the product to ensure its safety and efficacy.
Additional Clinical Information
The product is administered orally, with a recommended frequency of every 2 hours or as directed by a healthcare professional. Clinicians should advise patients who are pregnant or breastfeeding to consult their doctor prior to use. Additionally, it is important for caregivers to supervise the use of this product in children under 12 years of age, and to seek guidance from a doctor or dentist for children under 3 years of age.
No further information is available regarding laboratory tests, abuse potential, or postmarketing experience.
Drug Information (PDF)
This file contains official product information for Sore Throat, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.