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Sore Throat Cherry
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- Active ingredient
- Phenol 1.5 g/100 mL
- Other brand names
- Dosage form
- Liquid
- Route
- Oral
- Prescription status
- OTC (over the counter)
- Pregnancy
- See Pregnancy Use Section
- Lactation
- See Lactation Use Section
- Marketed in the U.S.
- Since 2012
- Label revision date
- September 19, 2025
- Drug Information (PDF)
- Prescribing information, PDF file
- Active ingredient
- Phenol 1.5 g/100 mL
- Other brand names
- Dosage form
- Liquid
- 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 2012
- Label revision date
- September 19, 2025
- Manufacturer
- Major Pharmaceuticals
- Registration number
- M013
- NDC root
- 0904-6305
- 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
Major Sore Throat Spray is designed to provide temporary relief from occasional minor irritation, pain, and soreness in the mouth and throat. This sugar-free, aspirin-free, and gluten-free spray comes in a pleasant cherry flavor and is packaged in a 6 FL OZ (177 mL) bottle. It works by alleviating sore throat pain, making it a helpful option when you're experiencing discomfort.
This product is comparable to the active ingredient found in CHLORASEPTIC®, offering a familiar solution for soothing throat irritation.
Uses
You can use this medication for the temporary relief of occasional minor irritation, pain, sore mouth, and sore throat. It’s designed to help soothe discomfort you might experience in these areas, making it easier for you to go about your day.
Rest assured, there are no known teratogenic effects (which means it doesn’t cause birth defects) associated with this medication, so it’s considered safe in that regard.
Dosage and Administration
To use this medication, start by applying one spray to the affected area. After spraying, it's important to let it sit for at least 15 seconds before you spit it out. You can use this treatment every 2 hours, or follow your doctor or dentist's specific instructions.
For adults and children aged 6 years and older, you should spray the affected area five times for each application. If you're using this medication for children under 12 years old, make sure they are supervised during the application. If the child is under 3 years old, it's best to consult with a doctor or dentist before use.
What to Avoid
It's important to use this medication responsibly. You should never exceed the recommended dosage, as doing so can lead to serious health issues. While there are no specific contraindications or concerns about abuse, misuse, or dependence associated with this medication, following the guidelines is crucial for your safety and well-being. Always consult with your healthcare provider if you have any questions or concerns about your treatment.
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 your doctor right away, as these symptoms may indicate a serious condition. You should not use this medication for more than two days or give it to children under six years old unless directed by a doctor.
Additionally, 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 seek advice from a doctor or dentist. Be alert for any swelling, rash, or fever that develops, as these may also require medical attention.
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, as this could be a serious condition. You should not use this medication for more than two days or give it to children under 6 years old unless directed by a healthcare professional.
In case of an overdose or accidental poisoning, seek emergency medical help immediately or contact a Poison Control Center at 1-800-222-1222. Additionally, 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 taking the medication and call your doctor. Be alert for any swelling, rash, or fever that develops, as these may require immediate medical attention.
Overdose
It appears that there is no specific information available regarding overdosage for this medication. However, it's always important to be aware of the signs of an overdose, which can include unusual drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it’s crucial to seek immediate medical help.
In case of an emergency, call your local emergency number or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any potential risks. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.
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 your health during this time.
Lactation Use
If you are pregnant or breastfeeding, it’s important to consult your doctor 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 healthcare provider to ensure safe practices while nursing.
Pediatric Use
It's important to be cautious when using this product for children. You should not use it for more than 2 days or give it to children under 6 years old unless a doctor specifically advises you to do so. For children under 12 years, it's best to supervise their use of the product to ensure safety.
If your child is under 3 years old, you should consult with a doctor or dentist before using this product. Always prioritize your child's health and safety by following these guidelines.
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 healthcare providers may not have tailored guidelines for elderly patients, which can be important given the unique health considerations that often come with aging.
If you or a caregiver are considering this medication for an older adult, it’s essential to consult with a healthcare professional. They can provide personalized advice and monitor for any potential side effects or interactions with other medications that may be more relevant for older individuals. 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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.
Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment and what steps to take for your safety.
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 determine the best course of action based on your individual situation.
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 feel free to ask questions and share your complete list of medications and any tests you might be undergoing. This way, you can avoid any potential issues and receive the best care possible.
Storage and Handling
To ensure the best performance and safety of your product, store it at room temperature. It's also important to check the expiration date before using it, as using expired products can compromise safety and effectiveness. By following these simple steps, you can help ensure that your product remains safe and effective for your needs.
Additional Information
You should apply the spray to the affected area by using one spray and allowing it to remain in place for at least 15 seconds before spitting it out. This can be done every 2 hours or as directed by your doctor or dentist. For adults and children aged 6 years and older, use 5 sprays for each application. If you are supervising a child under 12, please ensure they use the product correctly. For children under 3 years of age, consult a doctor or dentist before use.
FAQ
What is Major Sore Throat Spray used for?
Major Sore Throat Spray is used for the temporary relief of occasional minor irritation, pain, sore mouth, and sore throat.
What are the key features of Major Sore Throat Spray?
It is sugar-free, aspirin-free, gluten-free, and comes in a cherry flavor. The spray is available in a 6 FL OZ (177 mL) bottle.
How should I use Major Sore Throat Spray?
Apply one spray to the affected area, allow it to remain for at least 15 seconds, then spit it out. Use every 2 hours or as directed by a doctor or dentist.
Who can use Major Sore Throat Spray?
Adults and children 6 years of age and older can use it. Children under 12 should be supervised, and those under 3 should consult a doctor or dentist.
Are there any warnings associated with Major Sore Throat Spray?
Yes, consult a doctor if sore throat symptoms persist for more than 7 days, or if you experience severe symptoms like high fever or nausea. Do not use for more than 2 days without a doctor's direction.
What should I do in case of an overdose?
In case of overdose or accidental poisoning, seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.
Is Major Sore Throat Spray safe during pregnancy or breastfeeding?
You should ask a doctor before using Major Sore Throat Spray if you are pregnant or breastfeeding.
What should I do if my symptoms do not improve?
If your sore mouth symptoms do not improve in 7 days, or if irritation, pain, or redness worsens, stop using the spray and consult a doctor.
How should I store Major Sore Throat Spray?
Store Major Sore Throat Spray at room temperature and check the expiration date before use.
Packaging Info
Below are the non-prescription pack sizes of Sore Throat Cherry (phenol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Liquid | 1.5 g/100 mL | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
Drug Information (PDF)
This file contains official product information for Sore Throat Cherry, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.
Description
No description information is available for the specified drug.
Uses and Indications
This drug is indicated for the temporary relief of occasional minor irritation, pain, sore mouth, and sore throat.
There are no teratogenic or nonteratogenic effects associated with this drug.
Dosage and Administration
The product is intended for topical application to the affected area. For each application, one spray should be administered, which equates to five sprays per dose. After application, the product should be allowed to remain in place for a minimum of 15 seconds before being expectorated.
The recommended frequency of use is every 2 hours, or as directed by a healthcare professional.
For adults and children aged 6 years and older, the dosing regimen is consistent with the aforementioned application method. It is advised that children under 12 years of age be supervised during the use of this product to ensure proper administration.
For children under 3 years of age, consultation with a doctor or dentist is recommended prior to use.
Contraindications
There are no contraindications listed for this product. However, it is essential to adhere to the recommended dosage guidelines to ensure safe and effective use. Exceeding the recommended dosage may lead to adverse effects.
Warnings and Precautions
Severe or persistent sore throat, particularly when accompanied by high fever, headache, nausea, or vomiting, may indicate a serious condition. Healthcare professionals are advised to consult a physician promptly in such cases. It is important to note that the product should not be used for more than two days, and it is contraindicated for children under six years of age unless specifically directed by a healthcare provider.
In the event of an overdose or accidental poisoning, immediate medical assistance is crucial. Healthcare professionals should instruct patients to seek emergency medical help or contact a Poison Control Center at 1-800-222-1222 without delay.
Patients should be advised to discontinue use and contact their healthcare provider if sore mouth symptoms do not improve within seven days. Additionally, if any irritation, pain, or redness persists or worsens, or if swelling, rash, or fever develops, medical consultation is necessary to ensure patient safety and appropriate management.
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 more 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 6 years of age unless directed by a doctor.
In addition to serious reactions, patients should discontinue use and seek medical advice if sore mouth symptoms do not improve within 7 days. Other concerning signs that warrant medical consultation include persistent or worsening irritation, pain, or redness, as well as the development of swelling, rash, or fever. These guidelines are essential for ensuring patient safety and effective management of potential adverse reactions.
Drug Interactions
There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are necessary at this time.
Packaging & NDC
Below are the non-prescription pack sizes of Sore Throat Cherry (phenol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Liquid | 1.5 g/100 mL | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
Pediatric Use
Pediatric patients should not use this product for more than 2 days or be administered to children under 6 years of age unless directed by a healthcare professional. Additionally, children under 12 years of age should be supervised during the use of this product. For children under 3 years of age, it is advised to consult a doctor or dentist 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 before using this medication. The potential risks and benefits must be carefully considered in these populations. There is limited data available regarding the effects of this medication on fetal outcomes or during lactation, and therefore, healthcare providers should evaluate the necessity of treatment against any potential risks to the mother and child.
Lactation
Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is limited information available regarding the excretion of this drug in human breast milk and its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating mothers.
Renal Impairment
There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider individual patient factors when prescribing to patients with renal impairment, as the absence of detailed guidance necessitates careful clinical judgment.
Hepatic Impairment
Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.
Overdosage
In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.
Healthcare providers should be aware that the clinical presentation of an overdose may vary significantly depending on the substance involved and the individual patient’s characteristics. Symptoms of overdose can range from mild to severe and may include altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.
In the event of suspected overdosage, immediate medical evaluation is recommended. Healthcare professionals should assess the patient's vital signs and conduct a thorough clinical examination. Supportive care should be initiated as necessary, including airway management, oxygen supplementation, and intravenous fluids.
If the specific agent involved in the overdose is known, appropriate antidotes or specific treatments should be administered as indicated. Continuous monitoring of the patient’s condition is crucial, and healthcare providers should be prepared to manage complications that may arise during the course of treatment.
In all cases of suspected overdose, it is advisable to contact a poison control center or consult relevant clinical guidelines for further management recommendations.
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 compound in these areas.
Postmarketing Experience
No postmarketing experience details are available in the provided data.
Patient Counseling
Healthcare providers should advise patients to keep this product out of the reach of children. In the event of an overdose or accidental poisoning, patients should seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.
Patients should be informed to discontinue use and consult a doctor or dentist if symptoms of a sore mouth do not improve within 7 days. Additionally, they should be instructed to stop using the product and seek medical advice if they experience persistent or worsening irritation, pain, or redness. Patients should also be made aware that they need to stop use and consult a healthcare professional if they develop swelling, rash, or fever.
It is important to remind patients not to exceed the recommended dosage while using this product.
Storage and Handling
The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at room temperature to maintain its efficacy. Healthcare professionals are advised to check the expiration date before use to ensure the product's safety and effectiveness.
Additional Clinical Information
Patients should apply the product to the affected area using one spray, allowing it to remain in place for at least 15 seconds before spitting it out. The recommended frequency of administration is every 2 hours or as directed by a healthcare professional. For each application, adults and children aged 6 years and older should spray 5 times. It is advised that children under 12 years of age be supervised during use, and for children under 3 years of age, consultation with a doctor or dentist is recommended.
No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.
Drug Information (PDF)
This file contains official product information for Sore Throat Cherry, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.