Chloraseptic Warming Honey Lemon

Description

No description information is available.

Uses and Indications

This drug is indicated for the temporary relief of occasional minor irritation, pain, sore throat, and sore mouth. It is safe for use in the family population aged 6 years and older.

Dosage and Administration

Adults and children 6 years of age and older are instructed to take 1 lozenge every 2 hours as needed. The lozenge should be allowed to dissolve slowly in the mouth to ensure optimal absorption and effectiveness.

Use of this product is not recommended for children under 6 years of age.

Contraindications

Use is contraindicated in the following situations:

The product should not be used for teething. Additionally, it is contraindicated in children under 6 years of age due to safety concerns.

Patients must not exceed the recommended dosage to avoid potential adverse effects.

Warnings and Precautions

Use of this product carries a risk of methemoglobinemia, a serious condition characterized by reduced oxygen transport in the blood. This condition can manifest even in individuals who have previously used the product without issue. Immediate medical attention is required if symptoms such as pale, gray, or blue-colored skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness or lightheadedness, or fatigue occur in the patient or a child under their care.

Healthcare professionals should be aware of the allergy alert associated with this product. It is contraindicated in individuals with a known allergy to local anesthetics, including procaine, butacaine, benzocaine, or other “caine” anesthetics. Should a skin reaction arise, the product must be discontinued immediately, and medical assistance should be sought.

In cases of severe or persistent sore throat, particularly when accompanied by high fever, headache, nausea, or vomiting, it is imperative to consult a physician promptly. The product should not be used for more than two days, nor should it be administered to children under six years of age unless specifically directed by a healthcare provider.

In the event of an overdose, it is crucial to seek medical help or contact a Poison Control Center at 1-800-222-1222 without delay.

Healthcare providers should advise patients to discontinue use and consult a dentist or physician if any of the following occur: sore mouth symptoms do not improve within seven days; irritation, pain, or redness persists or worsens; or if swelling, rash, or fever develops.

Side Effects

The use of this product may lead to serious adverse reactions, including methemoglobinemia, which is a condition that significantly reduces the oxygen-carrying capacity of the blood. Patients should be aware that methemoglobinemia can occur even after prior use of the product. Immediate medical attention is required if symptoms such as pale, gray, or blue-colored skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness or lightheadedness, or fatigue or lack of energy develop.

Additionally, there is an allergy alert associated with this product. Patients with a history of allergy to local anesthetics, including procaine, butacaine, benzocaine, or other “caine” anesthetics, should not use this product. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance promptly.

Patients should also be cautious regarding severe or persistent sore throat symptoms. If a sore throat is accompanied by high fever, headache, nausea, or vomiting, it may indicate a serious condition, and consultation with a healthcare provider is advised. The product should not be used for more than 2 days, nor should it be administered to children under 6 years of age unless directed by a physician.

Furthermore, patients are advised to stop use and consult a dentist or doctor if sore mouth symptoms do not improve within 7 days, if irritation, pain, or redness persists or worsens, or if swelling, rash, or fever develops.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Chloraseptic Warming Honey Lemon (benzocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 6 years of age should not use this medication, particularly for teething, unless directed by a healthcare professional. For children aged 6 years and older, the recommended dosage is 1 lozenge every 2 hours as needed, with the instruction to allow the lozenge to dissolve slowly in the mouth. It is advised that this medication not be used for more than 2 days in pediatric patients without medical guidance.

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 potential 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 a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

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 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 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 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 1-800-222-1222 for guidance on managing the situation effectively.

Prompt intervention is crucial, as the symptoms of an overdose may vary depending on the substance involved. Therefore, a thorough assessment and appropriate management strategies should be implemented based on the specific clinical scenario presented.

Healthcare providers should ensure that they are prepared to provide supportive care and monitor the patient closely for any adverse effects that may arise from the overdose.

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

Postmarketing experience has identified the potential for methemoglobinemia associated with the use of this product. This serious condition can occur even in individuals who have previously used the product without incident, as it reduces the oxygen-carrying capacity of the blood and requires prompt treatment.

In cases where symptoms develop, it is advised to discontinue use and seek immediate medical attention if any of the following occur: pale, gray, or blue-colored skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness or lightheadedness, or fatigue or lack of energy.

Additionally, an allergy alert has been noted. The product should not be used by individuals with a known history of allergy to local anesthetics, including procaine, butacaine, benzocaine, or other “caine” anesthetics. In the event of a skin reaction, it is recommended to stop use and seek medical assistance promptly.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is crucial to emphasize the importance of adhering to the recommended dosage and not exceeding it.

Patients should be instructed to discontinue use and consult a dentist or doctor if symptoms of a sore mouth do not show improvement within 7 days. Additionally, they should be made aware that if they experience persistent or worsening irritation, pain, or redness, they must stop using the product and seek professional advice.

Furthermore, patients should be informed to stop use and consult a healthcare professional if they notice any signs of swelling, rash, or fever. This guidance is essential for ensuring patient safety and effective management of their condition.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at a temperature range of 15º to 30º C (59º to 86º F) to maintain its efficacy. It is essential to protect the product from moisture to ensure its integrity. Healthcare professionals are advised to check the expiration date before use to guarantee safety and effectiveness.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Chloraseptic Warming Honey Lemon, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)