Cold Flu and Sore Throat Relief

Description

CAREONE COLD, FLU & SORE THROAT RELIEF is presented in a dosage form of softgels, with a total count of 16 softgels per package. The product is identified by the National Drug Code (NDC) 41520-984-14. This formulation is designed to provide relief from symptoms associated with cold, flu, and sore throat, and it contains active ingredients that are comparable to those found in Mucinex® Fast-Max® Cold, Flu & Sore Throat.

Uses and Indications

This drug is indicated for the temporary relief of nasal congestion, headache, cough, minor aches and pains, and sore throat. It also temporarily reduces fever and aids in loosening phlegm (mucus) and thinning bronchial secretions, facilitating the clearance of mucus from the bronchial passageways and making coughs more productive.

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage to avoid potential overdose. The maximum allowable dosage is 12 liquid gels within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is 2 liquid gels every 4 hours as needed. It is imperative that patients do not exceed the specified dosage within the given time frame.

Use of this medication is not recommended for children under 12 years of age.

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 a period of 2 weeks following the discontinuation of an MAOI. If there is uncertainty about the presence of an MAOI in a prescription medication, a healthcare professional should be consulted prior to use.

• It is also advised to adhere strictly to the recommended dosage and not exceed the directed amount when using this product.

Warnings and Precautions

This product contains acetaminophen, which carries significant risks that healthcare professionals must communicate to patients.

Liver Warning Severe liver damage may occur if the maximum daily dosage of 12 softgels is exceeded within a 24-hour period. Additionally, the risk increases if acetaminophen is taken concurrently with other medications containing acetaminophen or if the patient consumes three or more alcoholic drinks daily while using this product.

Allergy Alert Acetaminophen may lead to severe skin reactions. Symptoms can include skin reddening, blisters, and rash. If any skin reaction occurs, patients should be advised to discontinue use immediately and seek medical assistance.

Sore Throat Warning Patients experiencing a severe sore throat that persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, should be instructed to consult a physician promptly.

General Precautions Healthcare professionals should advise patients to consult a doctor before using this product if they have any of the following conditions: liver disease, heart disease, diabetes, high blood pressure, thyroid disease, difficulty urinating due to an enlarged prostate gland, or a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, patients should be cautioned to seek advice from a doctor or pharmacist if they are taking the anticoagulant warfarin.

Emergency Medical Help In the event of an overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center or seek emergency medical help, regardless of whether they exhibit signs or symptoms.

Discontinuation of Use Patients should stop taking this product and consult a doctor if they experience nervousness, dizziness, or sleeplessness. They should also seek medical advice if pain, nasal congestion, or cough worsens or persists beyond seven days, if fever worsens or lasts more than three days, if redness or swelling occurs, if new symptoms develop, or if a cough recurs with a rash or headache that lasts. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of 12 softgels 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. In cases of overdose, which may also lead to liver damage, it is imperative for patients to seek immediate medical assistance or contact a Poison Control Center, as prompt medical attention is critical for both adults and children, even in the absence of noticeable symptoms.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. If any of these symptoms occur, patients are advised to discontinue use and seek medical help immediately. Additionally, if a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients should consult a healthcare professional without delay.

Patients are encouraged to stop use and consult a doctor if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or lasts longer than seven days; if fever worsens or persists beyond three days; if redness or swelling is observed; if new symptoms arise; or if a cough recurs or occurs with a rash or headache that lasts, as these may indicate a serious condition.

Before using this product, patients should consult a healthcare provider if they have a history of 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, or a cough that produces excessive phlegm, should also seek medical advice prior to use. Furthermore, patients taking the blood-thinning medication warfarin should consult a doctor or pharmacist before using this product.

Drug Interactions

Concurrent use of this medication with any other drug 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, as well as for a period of two weeks following the discontinuation of an MAOI. This combination may lead to serious and potentially life-threatening 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 necessary to ensure safe use and to avoid potential alterations in the effectiveness of warfarin therapy.

Packaging & NDC

Below are the non-prescription pack sizes of Cold Flu and Sore Throat Relief (acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride). 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 2 liquid gels 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 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. 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 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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data 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 exercise caution when using this product, which contains acetaminophen. Severe liver damage may occur if patients exceed the maximum daily amount of 12 softgels within a 24-hour period, take this product in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

It is advised that patients with a history of liver disease consult a healthcare professional prior to use. Additionally, taking more than the recommended dose can lead to overdose, which may result in liver damage. In the event of an overdose, it is imperative that patients seek immediate medical assistance or contact a Poison Control Center, as prompt medical attention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

Overdosage

In the event of an overdose, defined as the ingestion of more than the recommended dose, there is a significant risk of liver damage. It is imperative that healthcare professionals recognize the seriousness of this condition and act swiftly.

Immediate medical assistance is crucial. In cases of suspected overdose, it is recommended to seek medical help or contact a Poison Control Center without delay. This action is essential for both adults and children, as prompt intervention can mitigate potential complications.

Even in the absence of noticeable signs or symptoms, the need for quick medical attention cannot be overstated. Healthcare providers should ensure that patients and caregivers are aware of the importance of monitoring for any delayed effects and the necessity of professional evaluation following an overdose incident.

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

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, if fever worsens or lasts more than three days, or if any redness or swelling occurs. Patients should also be advised to seek medical attention if new symptoms arise or if a cough returns, especially if accompanied by a 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. Healthcare providers should encourage 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 using this product. Furthermore, patients should be advised to consult a doctor if they have a cough that produces 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) to maintain its efficacy. Care should be taken to avoid exposure to excessive heat, as this may compromise the integrity of the product. Proper storage conditions are crucial for ensuring the quality and safety of the product throughout its shelf life.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is 2 liquid gels every 4 hours. It is contraindicated for use in children under 12 years of age. No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

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)