Cold, Flu and Sore Throat Relief

Description

No relevant information is available for SPL code 34089-3.

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms, including cough, nasal congestion, minor aches and pains, sore throat, headache, stuffy nose, and sinus congestion and pressure. Additionally, it temporarily reduces fever and aids in loosening phlegm (mucus) and thinning bronchial secretions, facilitating the expulsion of bothersome mucus and enhancing the productivity of coughs.

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 dosage using only the dosing cup provided with the product; the dosing cup should not be utilized for any other products to ensure accurate measurement.

For adults and children aged 12 years and older, the recommended dose is 20 mL, administered orally every 4 hours as needed. For children under 12 years of age, the use of this product is not recommended.

Administration should be performed orally, utilizing the dosing cup provided, and the frequency of administration is every 4 hours. Healthcare professionals should counsel patients on the importance of not exceeding the directed dosage to avoid potential overdose.

Contraindications

Use of this product is contraindicated in the following situations:

• Concurrent use with any other drug containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose.

• In patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing an MAOI, as this may lead to serious drug interactions. If there is uncertainty regarding the presence of an MAOI in a prescription medication, consultation with a healthcare professional is advised.

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 to adhere strictly to the following recommendations to mitigate this risk:

Liver Warning Patients must not exceed 6 doses within a 24-hour period, as this represents the maximum daily amount. Caution is also warranted when this product is used in conjunction with other medications containing acetaminophen. Additionally, consumption of 3 or more alcoholic drinks daily while using this product may further increase the risk of liver damage.

Allergy Alert Acetaminophen may 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.

Sore Throat Warning In cases of severe sore throat that persists for more than 2 days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting, patients should be instructed to consult a healthcare provider without delay.

Monitoring and Consultation Patients should be advised to stop use and consult a doctor if they experience any of the following: nervousness, dizziness, or sleeplessness; worsening pain, nasal congestion, or cough lasting more than 7 days; fever that worsens or persists beyond 3 days; any signs of redness or swelling; the emergence of new symptoms; or if a cough recurs, particularly if accompanied by fever, rash, or headache lasting for an extended period. These symptoms may indicate a serious underlying condition that requires prompt medical evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily amount of six doses within a 24-hour period, take the product in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

In cases of severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients are advised to consult a healthcare professional promptly.

Overdose of the product can lead to liver damage. Patients who suspect an overdose should seek medical help or contact a Poison Control Center immediately at 1-800-222-1222. Timely medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Patients are also advised to stop use and consult a doctor if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or lasts more than seven days; if fever worsens or lasts more than three days; if redness or swelling is present; if new symptoms arise; or if a cough recurs with fever, rash, or headache that persists. These symptoms may indicate a serious condition requiring medical evaluation.

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, which can lead to severe liver damage.

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for the treatment of depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, it should not be administered within 2 weeks of discontinuing an MAOI, as this may lead to serious adverse effects.

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 safe use and to mitigate the risk of potential interactions that could affect bleeding risk.

Packaging & NDC

Below are the non-prescription pack sizes of Cold, Flu and Sore Throat Relief (acetaminophen 650 mg, dextromethorphan hbr 20 mg, guaifenesin 400 mg, phenylephrine hcl 10 mg). 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 every 4 hours using the dosing cup provided.

Geriatric Use

There is no specific information 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 they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy 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 considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in 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 should be closely monitored due to the potential risk of severe liver damage associated with the use of this product, which contains acetaminophen. It is critical that patients do not exceed 6 doses within a 24-hour period, as this represents the maximum daily amount. Additionally, patients must avoid concomitant use with other medications containing acetaminophen to prevent cumulative dosing that could lead to hepatotoxicity.

Furthermore, patients consuming 3 or more alcoholic drinks daily while using this product are at an increased risk for liver damage. Therefore, it is advisable for healthcare providers to assess liver function and consider the overall alcohol consumption of patients prior to prescribing this medication. Regular monitoring of liver function tests may be warranted in patients with existing hepatic impairment to ensure safety and efficacy during treatment.

Overdosage

Taking more than the recommended dose of this medication may lead to serious liver damage. In the event of an overdose, it is imperative to seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222.

Recommended Actions

Prompt medical attention is crucial for both adults and children, even if no signs or symptoms of overdose are apparent. Healthcare professionals should be vigilant in assessing the situation and providing necessary interventions.

Potential Symptoms

While specific symptoms of overdose are not detailed, the risk of liver damage underscores the importance of monitoring for any signs of hepatic distress.

Management Procedures

Upon recognition of an overdose, healthcare providers should initiate appropriate management protocols, which may include supportive care and monitoring of liver function. Early intervention can significantly impact patient outcomes.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. Patients should be instructed not to use this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult a doctor or pharmacist.

It is important to inform patients that they should not use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the last two weeks. Patients should be advised to check with their healthcare provider if they are unsure whether their prescription medication contains an MAOI.

Patients should be instructed to discontinue use and seek medical advice if they experience nervousness, dizziness, or sleeplessness. Additionally, they should be informed to stop using the product and consult a doctor if pain, nasal congestion, or cough worsens or persists for more than seven days, or if fever worsens or lasts more than three days. Patients should also be advised to seek medical attention if they notice redness or swelling, if new symptoms arise, or if a cough returns or occurs with fever, rash, or a headache that lasts, as these may indicate a serious condition.

When using this product, patients must be reminded not to exceed the recommended dosage. It is essential for patients to consult a doctor before use if they have any of the following conditions: liver disease, heart disease, diabetes, high blood pressure, thyroid disease, or difficulty urinating due to an enlarged prostate gland. Patients with a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, should also seek medical advice before use. Furthermore, patients should be advised to consult a doctor if they have a cough accompanied by excessive phlegm (mucus) or if they are taking the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a temperature range of 20-25°C (68-77°F). Refrigeration is not recommended, as the product should not be exposed to lower temperatures. Proper storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)