Cough and Sore Throat

Description

CVS 662L is a cough and sore throat remedy formulated with honey. It is designed to provide symptomatic relief for cough and throat irritation. The product is presented in a liquid dosage form, ensuring ease of administration. The specific composition and concentration of active ingredients are tailored to effectively address the discomfort associated with cough and sore throat conditions.

Uses and Indications

This drug is indicated for the temporary relief of cough due to minor throat and bronchial irritation, which may occur with the common cold or inhaled irritants. It is also indicated for the reduction of the intensity of coughing and the impulse to cough, thereby facilitating sleep. Additionally, this drug provides temporary relief from minor aches and pains, sore throat, and headache. It is further indicated for the temporary reduction of fever.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Patients should adhere strictly to the recommended dosage and administration guidelines. The maximum dosage should not exceed 6 doses within a 24-hour period. It is imperative to measure the dose using only the dosing cup provided with the product; the dosing cup should not be utilized for any other products to ensure accurate dosing.

For adults and children aged 12 years and older, the recommended dose is 20 mL, administered every 4 hours as needed. For children under 12 years of age, the use of this product is not recommended. Healthcare professionals should counsel patients to follow these instructions carefully and to consult a physician if there are any questions or concerns regarding the appropriate use of the medication.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs), which are utilized for the treatment of depression, psychiatric or emotional conditions, or Parkinson's disease, is contraindicated. This includes a prohibition on use for 2 weeks following the discontinuation of an MAOI. Patients should verify with a healthcare professional if their prescription medications contain an MAOI prior to using this product.

Warnings and Precautions

This product contains acetaminophen, which carries a significant risk of severe liver damage if not used according to the guidelines. Healthcare professionals should advise patients that the maximum daily dosage is limited to 6 doses within a 24-hour period. Patients must be cautioned against concurrent use with other medications containing acetaminophen and should be informed that consuming three or more alcoholic drinks daily while using this product may exacerbate the risk of liver damage.

Acetaminophen may also induce severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. Should any of these symptoms manifest, patients are advised to discontinue use immediately and seek medical assistance.

In cases of severe sore throat, particularly if it persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be instructed to consult a physician without delay.

General precautions should be taken when considering the use of this product. Patients with liver disease, persistent or chronic cough (such as that associated with smoking, asthma, or emphysema), or cough accompanied by excessive phlegm should seek medical advice prior to use. Additionally, patients taking the anticoagulant warfarin should consult a healthcare provider or pharmacist before using this product.

In the event of an overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center (1-800-222-1222) or seek emergency medical help right away, as prompt intervention is essential for both adults and children, even in the absence of noticeable symptoms.

Patients should discontinue use and contact a healthcare professional if any of the following occur: worsening pain or cough lasting more than 7 days, fever that worsens or persists beyond 3 days, presence of redness or swelling, emergence of new symptoms, or recurrence of cough accompanied by rash or headache lasting for an extended period. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur if patients exceed 6 doses in a 24-hour period, which is the maximum daily amount, or if they take this product in conjunction with other medications containing acetaminophen. Additionally, consumption of 3 or more alcoholic drinks daily while using this product may increase the risk of liver damage.

There is also an allergy alert associated with acetaminophen, as it may cause severe skin reactions. Symptoms of such reactions can include skin reddening, blisters, and rash. If any of these symptoms occur, patients are advised to discontinue use immediately and seek medical assistance.

Patients should be vigilant regarding sore throat symptoms. If a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, it is recommended that they consult a doctor promptly.

Patients are instructed to stop use and consult a healthcare professional if pain or cough worsens or lasts more than 7 days, if fever worsens or lasts more than 3 days, if redness or swelling is present, if new symptoms occur, or if a cough returns or occurs with a rash or headache that lasts. These symptoms could indicate a serious condition.

Furthermore, an overdose warning is in place, as taking more than the recommended dose may lead to liver damage. In the event of an overdose, it is crucial for patients to seek medical help or contact a Poison Control Center (1-800-222-1222) immediately. Quick medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

Drug Interactions

Concurrent use of this medication with other products containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose and potential hepatotoxicity.

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric disorders, or Parkinson's disease. Additionally, it should not be administered for at least 2 weeks following the discontinuation of an MAOI to avoid serious interactions.

Patients taking the anticoagulant warfarin should consult with a healthcare professional, such as a doctor or pharmacist, prior to using this medication. Monitoring of coagulation parameters may be warranted to ensure safety and efficacy.

Packaging & NDC

Below are the non-prescription pack sizes of Cough and Sore Throat (acetaminophen, dextromethorphan hydrobromide liquid). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For adolescents aged 12 years and older, the recommended dosage is 20 mL, administered using the dosing cup provided, every 4 hours.

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 adverse effects or changes in therapeutic response, 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. The potential risks and benefits must be carefully considered, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to discuss their individual circumstances with a healthcare provider 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 drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals 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 should be aware that this product contains acetaminophen, which carries a risk of severe liver damage. It is crucial for these patients to adhere to the following guidelines to minimize the risk of liver injury.

The maximum recommended dosage is 6 doses within a 24-hour period. Patients with compromised liver function should avoid exceeding this limit and should not take this product in conjunction with other medications containing acetaminophen. Additionally, consumption of 3 or more alcoholic drinks daily while using this product is contraindicated, as it may exacerbate the risk of liver damage.

Patients with a history of liver disease are advised to consult a healthcare professional prior to using this product. In the event of an overdose, which is defined as taking more than the recommended dose, immediate medical assistance should be sought. Patients should contact a Poison Control Center at 1-800-222-1222 without delay, as prompt medical attention is essential for both adults and children, regardless of the presence of symptoms.

Overdosage

Taking more than the recommended dose of this medication may lead to significant liver damage. It is imperative that healthcare professionals remain vigilant regarding the potential for overdose and its serious consequences.

In the event of an overdose, immediate medical assistance should be sought. Healthcare providers are advised to contact a Poison Control Center at 1-800-222-1222 without delay. Quick intervention is crucial, as symptoms may not be immediately apparent. This applies to both adults and children, underscoring the importance of prompt medical evaluation even in the absence of overt signs or symptoms of overdose.

Timely management can significantly influence outcomes, making awareness and readiness to act essential components of care in cases of suspected 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 use of the compound in question.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions associated with acetaminophen use: severe skin reactions, which include skin reddening, blisters, and rash. These events have been reported voluntarily or through surveillance programs.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is important to inform patients about the risks associated with overdose, emphasizing that taking more than the recommended dose may lead to liver damage. In the event of an overdose, patients should seek medical help or contact a Poison Control Center (1-800-222-1222) immediately, as prompt medical attention is crucial for both adults and children, even if no symptoms are apparent.

Patients should be cautioned against using this product in conjunction with any other medications that contain acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should consult a doctor or pharmacist for clarification.

Healthcare providers should instruct patients not to use this medication if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. Patients should be encouraged to ask their healthcare provider or pharmacist if they are unsure whether their prescription medication contains an MAOI.

Patients should be advised to discontinue use and consult a doctor if their pain or cough worsens or persists for more than 7 days, if their fever worsens or lasts longer than 3 days, or if they notice any redness or swelling. Additionally, they should seek medical advice if new symptoms arise or if a cough returns, particularly if accompanied by a rash or headache that lasts, as these may indicate a serious condition.

While using this product, patients must adhere strictly to the directed dosage and should consult a doctor before use if they have liver disease, a persistent or chronic cough (such as that associated with smoking, asthma, or emphysema), or a cough that produces excessive phlegm. Furthermore, patients taking the blood-thinning medication warfarin should seek guidance from a doctor or pharmacist before using this product.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It should be stored at a temperature range of 20-25°C (68-77°F). It is important to avoid refrigeration to maintain the integrity of the product. Proper handling and storage conditions must be adhered to in order to ensure optimal quality and efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Cough and Sore Throat, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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