Severe Cold and Flu Relief

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and flu. Specifically, it addresses nasal congestion, sinus congestion and pressure, minor aches and pains, headache, fever, and sore throat. Additionally, it reduces swelling of the nasal passages and alleviates cough due to minor throat and bronchial irritation.

This medication temporarily restores freer breathing through the nose, promotes nasal and/or sinus drainage, and helps loosen phlegm (mucus) while thinning bronchial secretions. This action aids in clearing the bronchial passageways of bothersome mucus, thereby making coughs more productive.

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

Dosage and Administration

Patients should adhere strictly to the prescribed dosage to avoid the risk of overdose. The maximum allowable dosage is four doses within a 24-hour period.

For administration, the provided dosing cup must be used to measure the liquid accurately; no other dosing devices should be employed. It is essential to keep the dosing cup with the product to ensure proper measurement.

Dosage Guidelines:

• Adults and Children 12 Years and Over: Administer 30 mL every 4 hours as needed.

• Children 6 to Under 12 Years: Administer 15 mL every 4 hours as needed.

• Children 4 to Under 6 Years: Consult a physician for appropriate dosing.

• Children Under 4 Years: The product is not recommended for this age group.

When utilizing other Daytime or Nighttime products, it is crucial to read each label carefully to confirm the correct dosing regimen.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be used in conjunction with any other medication containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare professional is advised.

Additionally, the product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment. MAOIs are typically prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. If there is any doubt about the presence of an MAOI in a prescription medication, a healthcare professional should be consulted prior to use.

Patients are also advised 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 the risk of liver injury increases significantly if the following conditions are met: adults exceed 4 doses (30 mL each) of acetaminophen within a 24-hour period, children exceed 4 doses (15 mL each) in the same timeframe, the product is taken concurrently with other medications containing acetaminophen, or if adults consume 3 or more alcoholic beverages daily while using this product.

Acetaminophen is also associated with the potential for severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blistering, 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, it is imperative to consult a healthcare provider promptly.

Patients should be advised to stop use and consult a physician if they experience nervousness, dizziness, or sleeplessness. Additionally, if pain, nasal congestion, or cough worsens or lasts beyond 5 days in children or 7 days in adults, or if new symptoms arise, medical advice should be sought. Persistent fever lasting more than 3 days, redness or swelling, or a cough that recurs or is accompanied by a rash or headache may indicate a serious condition requiring further evaluation.

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 without delay, even if no signs or symptoms are apparent, as prompt intervention is critical for both adults and children.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed the recommended dosage. Adults should not take more than 4 doses (30 mL each) in 24 hours, while children should not exceed 4 doses (15 mL each) in the same timeframe. The risk of liver damage is 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, which may manifest as skin reddening, blistering, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

A sore throat that is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting warrants prompt consultation with a healthcare provider.

Patients are advised to stop use and consult a doctor if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or lasts beyond 5 days in children or 7 days in adults; if new symptoms arise; if fever worsens or lasts more than 3 days; if redness or swelling is observed; or if a cough recurs or occurs with a rash or headache that persists, as these may indicate a serious condition.

Prior to use, patients should consult a healthcare professional if they have a history of liver disease, heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate, a cough associated with excessive phlegm, or a persistent cough related to smoking, asthma, chronic bronchitis, or emphysema. Additionally, individuals on a sodium-restricted diet should seek medical advice before use.

Patients taking the blood-thinning medication warfarin should also consult a doctor or pharmacist before using this product.

In cases of overdose, which can lead to serious liver damage, immediate medical attention is crucial. Patients should contact a Poison Control Center (1-800-222-1222) right away, even if no signs or symptoms are present, as quick intervention is critical for both adults and children.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known 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 Severe Cold and Flu Relief (acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 12 years and over may be administered 30 mL every 4 hours. For children aged 6 to under 12 years, the recommended dosage is 15 mL every 4 hours. In 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: if a child takes more than 4 doses of 15 mL each within a 24-hour period, medical advice should be sought. Additionally, caregivers should be instructed to stop use and consult a doctor if the child's pain, nasal congestion, or cough worsens or persists for more than 5 days, or if new symptoms develop.

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. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and maternal health. 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 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 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 lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients, although specific recommendations are not provided.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. It is essential to adhere to the following guidelines to minimize the risk of severe liver damage.

Adults should not exceed 4 doses (30 mL each) of acetaminophen in a 24-hour period, as this is the maximum daily amount. For children, the maximum is 4 doses (15 mL each) within the same timeframe. Patients must also be aware that taking this product in conjunction with other medications containing acetaminophen can lead to severe liver damage.

Additionally, individuals who consume 3 or more alcoholic drinks daily should consult a healthcare professional before using this product, as the combination may increase the risk of liver injury.

Patients with known liver disease are advised to seek medical advice prior to use. In the event of an overdose, which can result in serious liver damage, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms of overdose are apparent.

Overdosage

Taking more than the recommended dose of this medication can 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. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are initially apparent.

Healthcare professionals should be aware that the absence of symptoms does not preclude the possibility of significant harm. Therefore, vigilance in monitoring and managing potential overdose cases is essential.

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

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions, which can manifest as skin reddening, blistering, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

Additionally, users are encouraged to stop use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Symptoms such as worsening pain, nasal congestion, or cough that persists beyond 5 days in children or 7 days in adults should also prompt a consultation. The emergence of new symptoms, a fever that worsens or lasts more than 3 days, or the presence of redness or swelling are further indicators for medical evaluation.

Recurrent cough, particularly when accompanied by a rash or a headache that persists, may signal a serious condition and warrants immediate attention.

Furthermore, an overdose warning is included, as exceeding the recommended dosage can lead to serious liver damage. In cases of overdose, it is critical to seek medical help or contact a Poison Control Center (1-800-222-1222) without delay, as prompt medical intervention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Patient Counseling

Healthcare providers should advise patients that taking more than the recommended dose of this medication can lead to serious liver damage. In the event of an overdose, patients must seek medical help 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 signs or symptoms are present.

Patients should be informed not to use this medication in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should consult a doctor or pharmacist for clarification.

It is important to instruct patients not to use this product 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 they experience nervousness, dizziness, or sleeplessness. Additionally, they should seek medical advice if pain, nasal congestion, or cough worsens or persists beyond 5 days in children or 7 days in adults. New symptoms, worsening fever lasting more than 3 days, or the presence of redness or swelling should also prompt a consultation with a healthcare provider. Patients should be made aware that a returning cough or one accompanied by a rash or persistent headache may indicate a serious condition, warranting immediate medical attention.

While using this product, patients must be reminded to adhere strictly to the directed dosage. Healthcare providers should encourage patients to consult a doctor before use if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. Patients with a cough that produces excessive phlegm or those with a persistent or chronic cough related to smoking, asthma, chronic bronchitis, or emphysema should also seek medical advice prior to use. Furthermore, patients on a sodium-restricted diet or those taking the blood-thinning medication warfarin should consult their healthcare provider or pharmacist before using this product.

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 handling and storage conditions must be adhered to in order to maintain product efficacy and safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)