ADD CONDITION
Cepastat
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This product has been discontinued
- Active ingredient
- Phenol 29 mg
- Other brand names
- 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 (by We Care Distributor Inc.)
- Sore Throat Cherry (by Major Pharmaceuticals)
- Vortex Moisturizer Oral (by Vortex Life Sciences, Inc.)
- View full label-group details →
- Dosage form
- Lozenge
- Route
- Oral
- Prescription status
- OTC (over the counter)
- Pregnancy
- See Pregnancy Use Section
- Lactation
- See Lactation Use Section
- Marketed in the U.S.
- Since 2009
- Label revision date
- July 9, 2009
- Drug Information (PDF)
- Prescribing information, PDF file
- Active ingredient
- Phenol 29 mg
- Other brand names
- 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 (by We Care Distributor Inc.)
- Sore Throat Cherry (by Major Pharmaceuticals)
- Vortex Moisturizer Oral (by Vortex Life Sciences, Inc.)
- View full label-group details →
- Dosage form
- Lozenge
- 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 2009
- Label revision date
- July 9, 2009
- Manufacturer
- Insight Pharmaceuticals
- Registration number
- part356
- NDC root
- 63736-219
- Drug Information (PDF)
- Prescribing information, PDF file
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Drug Overview
CĒPASTAT® is an oral anesthetic that contains phenol, designed to provide fast relief for minor sore throat pain, sore mouth, minor mouth irritation, and pain associated with canker sores. It comes in a pleasant menthol eucalyptus flavor and is available in an extra strength formulation, packaged as sugar-free lozenges for your convenience.
Uses
You can use this medication to temporarily relieve discomfort from minor sore throat pain, sore mouth, and minor mouth irritation. It is also effective for alleviating pain associated with canker sores. This means that if you're experiencing any of these issues, this medication may help ease your symptoms and make you feel more comfortable.
Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication, so it is considered safe in that regard.
Dosage and Administration
If you or your child are in need of relief, here’s how to use the lozenges effectively. For adults and children aged 12 years and older, you can take up to 2 lozenges every 2 hours as needed. If your child is between 6 and 12 years old, they should take up to 1 lozenge every 2 hours, but make sure they do not exceed 10 lozenges in a 24-hour period.
For children under 6 years old, it’s important to consult a doctor before giving them any lozenges. To use the lozenge, simply place it in your mouth and let it dissolve slowly. This method helps ensure that the medication works effectively.
What to Avoid
It's important to follow the instructions provided by your healthcare provider when using this medication. You should not take more than the recommended dose, as exceeding this can lead to unwanted effects.
Currently, there are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this medication. However, always prioritize safety by adhering to the prescribed guidelines.
Side Effects
If you experience a sore throat that is severe, lasts more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, it’s important to stop using the medication and consult your doctor. Additionally, if you have sore mouth symptoms that persist for more than seven days, or if you notice any irritation, pain, or redness that continues or worsens, seek medical advice promptly. Your health and safety are paramount, so don’t hesitate to reach out to a healthcare professional if you have concerns.
Warnings and Precautions
It's important to use this medication exactly as directed and not exceed the recommended dosage. If you experience a severe sore throat that lasts more than two days, or if it is accompanied by fever, headache, rash, nausea, or vomiting, you should stop using the medication and consult your doctor. Additionally, if symptoms in your sore mouth persist for more than seven days, or if you notice any worsening irritation, pain, or redness, please reach out to your healthcare provider.
Keep this medication out of reach of children. In the event of an overdose, seek medical assistance immediately or contact a Poison Control Center for help. Your safety is a priority, so please take these precautions seriously.
Overdose
If you suspect an overdose, 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 more severe than typical side effects.
Always err on the side of caution—if you notice anything concerning, don’t hesitate to reach out for assistance. Quick action can make a significant difference in ensuring your safety and well-being.
Pregnancy Use
If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.
Lactation Use
If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.
Pediatric Use
When it comes to using this medication for children, there are specific guidelines to follow. For children aged 6 to under 12 years, you can give them up to 1 lozenge every 2 hours, but make sure they do not exceed 10 lozenges in a 24-hour period.
If your child is under 6 years old, it’s important to consult with a doctor before using this medication. Always prioritize safety and seek professional advice when it comes to younger children.
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. Since older adults may have different health needs and responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the best approach for you or your loved one, considering any existing health conditions or medications that may interact.
Remember, your safety and well-being are the top priority, so don’t hesitate to ask questions and discuss any concerns with your doctor or pharmacist.
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 be adjusted based on your kidney function.
Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary changes to your medications.
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 determine the best approach based on your liver function and overall health.
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 and share your complete list of medications and tests during your appointments.
Storage and Handling
To ensure the best performance of your product, store it at room temperature, ideally below 86°F (30°C). It's important to keep the contents dry, so make sure to protect them from humidity. This will help maintain the quality and effectiveness of the device.
When handling the product, always do so with clean hands and in a clean environment to avoid contamination. Following these simple storage and handling guidelines will help ensure your safety and the product's reliability.
Additional Information
You can take this medication orally in the form of lozenges. If you are an adult or a child aged 12 years and older, you can take up to 2 lozenges every 2 hours as needed. For children aged 6 to under 12 years, the recommendation is to take up to 1 lozenge every 2 hours, but do not exceed 10 lozenges in a 24-hour period. If your child is under 6 years old, it's best to consult a doctor before giving them this medication.
FAQ
What is CĒPASTAT®?
CĒPASTAT® is an oral anesthetic that contains phenol and is designed to temporarily relieve minor sore throat pain, sore mouth, minor mouth irritation, and pain associated with canker sores.
How should I take CĒPASTAT®?
Adults and children 12 years and older can take up to 2 lozenges every 2 hours as needed. Children aged 6 to under 12 years should take up to 1 lozenge every 2 hours, not exceeding 10 lozenges in 24 hours.
Are there any side effects I should be aware of?
You should stop using CĒPASTAT® and ask a doctor if your sore throat is severe, lasts more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting.
Can I use CĒPASTAT® if I am pregnant or breastfeeding?
If you are pregnant or breastfeeding, you should ask a health professional before using CĒPASTAT®.
What should I do if I accidentally take too much CĒPASTAT®?
Keep CĒPASTAT® out of reach of children, and in case of overdose, seek medical help or contact a Poison Control Center immediately.
What flavor does CĒPASTAT® come in?
CĒPASTAT® is available in a menthol eucalyptus flavor.
How should I store CĒPASTAT®?
Store CĒPASTAT® at room temperature, below 86°F (30°C), and protect it from humidity.
Are there any contraindications for using CĒPASTAT®?
There are no contraindications listed for CĒPASTAT®.
Packaging Info
Below are the non-prescription pack sizes of Cepastat (phenol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Lozenge | 29 mg | ||
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 Cepastat, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.
Description
CĒPASTAT® is an oral anesthetic formulation that combines menthol eucalyptus flavor with phenol, designed for fast-acting relief of sore throat symptoms. This product is available in an extra strength dosage form, containing 18 sugar-free lozenges.
Uses and Indications
This drug is indicated for the temporary relief of minor sore throat pain, sore mouth, minor mouth irritation, and pain associated with canker sores.
There are no teratogenic or nonteratogenic effects associated with this drug.
Dosage and Administration
Adults and children aged 12 years and older may take up to 2 lozenges every 2 hours as needed. For children aged 6 to under 12 years, the recommended dosage is up to 1 lozenge every 2 hours, with a maximum of 10 lozenges in a 24-hour period. For children under 6 years of age, it is advised to consult a physician before administration.
The method of administration involves dissolving a lozenge slowly in the mouth to ensure optimal absorption and effectiveness.
Contraindications
There are no specific contraindications listed for this product. However, it is essential to adhere to the recommended dosage guidelines. Use of the product in excess of the directed amount is not advised.
Warnings and Precautions
The use of this medication requires careful adherence to the recommended dosage. It is imperative that healthcare professionals instruct patients not to exceed the directed dosage to avoid potential adverse effects.
Patients should be advised to discontinue use and seek medical attention if they experience a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting. Additionally, if symptoms of a sore mouth last longer than seven days, or if there is ongoing or worsening irritation, pain, or redness, medical consultation is necessary.
To ensure safety, this medication must be kept out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.
Side Effects
Patients should discontinue use and consult a healthcare professional if they experience a severe sore throat that lasts for more than 2 days, particularly if it is accompanied by fever, headache, rash, nausea, or vomiting. Additionally, if symptoms of a sore mouth persist for more than 7 days, or if there is ongoing or worsening irritation, pain, or redness, medical advice should be sought.
Drug Interactions
No drug interactions or drug and laboratory test interactions have been identified in the available data. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.
Packaging & NDC
Below are the non-prescription pack sizes of Cepastat (phenol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Lozenge | 29 mg | ||
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 6 to under 12 years may take up to 1 lozenge every 2 hours, with a maximum of 10 lozenges in a 24-hour period. For children under 6 years, it is advised to consult a doctor prior to use.
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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.
Pregnancy
Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.
Lactation
Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication 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 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 clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.
Overdosage
In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.
Healthcare professionals should be vigilant for symptoms that may arise from an overdose, although specific symptoms are not detailed in the provided information. The management of an overdose typically involves supportive care and symptomatic treatment, tailored to the individual patient's needs.
It is essential for healthcare providers to remain alert to the signs of overdose and to act swiftly in accordance with established medical protocols.
Nonclinical Toxicology
If pregnant or breast-feeding, it is advised to consult a health professional prior to use. No non-teratogenic effects have been specified in the available data. Additionally, there are no details provided regarding nonclinical toxicology or 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 the medication out of reach of children to prevent accidental ingestion. It is important for patients to understand the potential risks associated with overdose. In the event of an overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center for assistance. This information is crucial for ensuring patient safety and promoting responsible use of the medication.
Storage and Handling
The product is supplied in configurations that include specific NDC numbers. It should be stored at room temperature, ensuring that the temperature does not exceed 86°F (30°C). Additionally, it is essential to protect the contents from humidity to maintain product integrity. Proper handling and storage conditions are crucial for preserving the quality of the product.
Additional Clinical Information
The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is up to 2 lozenges every 2 hours as needed. For children aged 6 to under 12 years, the dosage is limited to 1 lozenge every 2 hours, with a maximum of 10 lozenges in a 24-hour period. For children under 6 years, it is advised to consult a doctor regarding appropriate use.
No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.
Drug Information (PDF)
This file contains official product information for Cepastat, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.