Cold and Flu Relief

Description

This formulation contains Acetaminophen 325 mg, a pain reliever and fever reducer, Dextromethorphan HBr 10 mg, a cough suppressant, and Phenylephrine HCl 5 mg, a nasal decongestant. It is intended for use in individuals aged 6 years and older. The product is alcohol-free and does not contain antihistamines. It is packaged with a tamper-evident feature; do not use if the printed safety seal around the dosage cup or under the cap is broken or missing. The product is distributed by Midwood Brands, LLC, located at 500 Volvo Parkway, Chesapeake, VA 23320.

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms, including minor aches and pains, headache, sore throat, fever, nasal congestion, and cough due to minor throat and bronchial irritation.

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

Dosage and Administration

For adults and children aged 12 years and older, the recommended dosage is 30 mL administered every 4 hours. For children aged 6 to under 12 years, the dosage is 15 mL every 4 hours. It is advised to consult a physician for children aged 4 to under 6 years regarding appropriate dosing. The product is not recommended for use in children under 4 years of age.

Healthcare professionals should ensure that patients do not exceed 4 doses within a 24-hour period. It is imperative to measure the dosage using only the dosing cup provided with the product; the use of any other dosing device is not recommended. The dosing cup should be kept with the product to facilitate accurate measurement.

When utilizing both Daytime and Nighttime formulations, it is essential to carefully read each label to confirm the correct dosing instructions.

Contraindications

Use of this product is contraindicated in the following situations:

Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or those who have discontinued MAOI therapy within the past two weeks. The combination may lead to serious interactions. If there is uncertainty regarding the presence of an MAOI in a prescription medication, consultation with a healthcare professional is advised.

Concurrent use with any other drug containing acetaminophen, whether prescription or non-prescription, is also contraindicated due to the risk of acetaminophen overdose. If there is doubt about the acetaminophen content of a medication, a healthcare professional should be consulted.

Additionally, it is important not to exceed the recommended dosage of this product.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients that adults must not exceed 4 doses (30 mL each) of acetaminophen within a 24-hour period, while children should not exceed 4 doses (15 mL each) in the same timeframe. Caution is also warranted if the product is taken concurrently with other medications containing acetaminophen or if the adult consumes 3 or more alcoholic drinks daily while using this product.

Acetaminophen may lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of any skin reaction, patients should be instructed to discontinue use immediately and seek medical assistance.

In cases of severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be advised to consult a physician promptly.

General precautions should be taken for individuals with specific health conditions. Patients should be encouraged to consult a healthcare provider prior to use if they have liver disease, heart disease, high blood pressure, thyroid disease, diabetes, a sodium-restricted diet, persistent or chronic cough (such as that associated with smoking, asthma, or emphysema), cough accompanied by excessive phlegm, or difficulty urinating due to an enlarged prostate gland. Additionally, it is important to consult a doctor or pharmacist if the patient is taking the anticoagulant warfarin.

In the event of an overdose, immediate medical attention is critical. Patients should be instructed to seek emergency medical help or contact a Poison Control Center (1-800-222-1222) without delay, even if no signs or symptoms are apparent.

Patients should be advised to discontinue use and contact their healthcare provider if they experience nervousness, dizziness, or sleeplessness. Furthermore, if pain, nasal congestion, or cough worsens or persists beyond 5 days in children or 7 days in adults, or if fever worsens or lasts more than 3 days, medical consultation is necessary. Redness or swelling, the emergence of new symptoms, or a recurrence of cough accompanied by rash or headache that lasts should also prompt a call to a healthcare professional, as these may indicate a serious condition.

Side Effects

Severe liver damage may occur in patients who exceed the recommended dosage of acetaminophen. Specifically, adults should not take more than 4 doses (30 mL each) in a 24-hour period, while children should not exceed 4 doses (15 mL each) within the same timeframe. The risk of liver damage is further heightened if acetaminophen is taken in conjunction with other medications containing acetaminophen or if an adult consumes 3 or more alcoholic drinks daily while using this product.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen use. Symptoms may include skin reddening, blisters, and 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 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, patients are advised to consult a healthcare professional promptly.

Patients should discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, if pain, nasal congestion, or cough worsens or lasts longer than 5 days in children or 7 days in adults, medical advice should be sought. A worsening fever or one that lasts more than 3 days, the presence of redness or swelling, the emergence of new symptoms, or a cough that recurs or occurs with a rash or headache lasting should also prompt immediate medical consultation, as these may indicate a serious condition.

Drug Interactions

The concomitant use of this medication with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients should not take this medication while on MAOIs or for a period of two weeks following the discontinuation of an MAOI. MAOIs are typically prescribed for conditions such as depression, certain psychiatric disorders, or Parkinson's disease.

Additionally, caution is advised when this medication is used in conjunction with warfarin, a blood-thinning agent. Patients are encouraged to consult with a healthcare professional, such as a doctor or pharmacist, prior to using this medication if they are currently taking warfarin. Monitoring of coagulation parameters may be warranted to ensure safety and efficacy.

Packaging & NDC

Below are the non-prescription pack sizes of Cold and Flu Relief (acetaminophen dextromethorphan hbr phenylephrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 6 to under 12 years may be administered 15 mL every 4 hours. For children aged 4 to under 6 years, it is advised to consult a doctor before use. The product is not recommended for children under 4 years of age.

Healthcare professionals should be aware of a liver warning indicating that children should not take more than 4 doses (15 mL each) within a 24-hour period. Additionally, caregivers should be instructed to stop use and consult a doctor if a child's pain, nasal congestion, or cough worsens or persists for more than 5 days, or if a fever worsens or lasts more than 3 days.

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 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 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 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.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. Severe liver damage may occur if the following dosing recommendations are not adhered to:

• Adults should not exceed 4 doses (30 mL each) of acetaminophen in a 24-hour period, which is the maximum daily amount.

• Children should not exceed 4 doses (15 mL each) in a 24-hour period.

• Patients should avoid taking this product in conjunction with other medications that contain acetaminophen.

• Adults consuming 3 or more alcoholic drinks daily while using this product are at an increased risk for liver damage.

It is advised that patients with a history of liver disease consult a healthcare professional prior to using this product.

In the event of an overdose, which may lead to liver damage, immediate medical assistance should be sought. Patients are encouraged to contact a Poison Control Center (1-800-222-1222) without delay, as prompt medical attention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

Overdosage

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

Recommended Actions

Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms. Healthcare professionals should be vigilant in assessing the situation, as early intervention can be critical in managing potential complications associated with overdose.

Potential Symptoms

While specific symptoms of overdose may not be immediately apparent, healthcare providers should remain alert to the possibility of liver-related issues developing. Continuous monitoring and evaluation of the patient's condition are essential to ensure appropriate management and intervention.

In summary, the importance of rapid response to an overdose cannot be overstated, and healthcare professionals are encouraged to act swiftly to mitigate risks associated with excessive dosing.

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. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients about the importance of adhering to the recommended dosage, as exceeding this dosage may lead to liver damage. In the event of an overdose, patients should seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is crucial for both adults and children, even if no symptoms are apparent.

Patients should be instructed to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, they should stop use and seek medical advice if pain, nasal congestion, or cough worsens or persists beyond 5 days in children or 7 days in adults. If fever intensifies or lasts more than 3 days, or if any redness or swelling occurs, patients should also stop use and contact a healthcare professional. New symptoms that arise should prompt a discussion with a doctor, as should a recurrence of cough, particularly if accompanied by a rash or persistent headache.

It is essential for patients to consult a doctor before using this medication if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or if they are on a sodium-restricted diet. Patients with a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, should also seek medical advice prior to use. Furthermore, those experiencing a cough with excessive phlegm or who have difficulty urinating due to an enlarged prostate gland should consult a healthcare provider. Lastly, patients taking the blood-thinning medication warfarin should discuss their use of this product with a doctor or pharmacist.

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 20-25ºC (68-77ºF). Refrigeration is not recommended, as it may compromise the integrity of the product. Proper storage conditions must be maintained to ensure optimal efficacy and safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

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