Daytime Severe Cold and Flu Relief

Description

This formulation is designed for maximum strength relief from severe cold and flu symptoms during the daytime. It contains the following active ingredients: acetaminophen, which serves as a pain reliever and fever reducer; dextromethorphan HBr, functioning as a cough suppressant; guaifenesin, an expectorant; and phenylephrine HCl, acting as a nasal decongestant. The product is free from gluten and alcohol, ensuring suitability for individuals with specific dietary restrictions. It is presented in a liquid dosage form, with a total volume of 12 fluid ounces (355 mL), and is formulated to be non-drowsy.

Uses and Indications

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

Additionally, this drug reduces swelling of the nasal passages, temporarily restores freer breathing through the nose, promotes nasal and/or sinus drainage, and helps to loosen phlegm (mucus) and thin 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 and administration guidelines. It is imperative to utilize only the dose cup provided with the medication to ensure accurate dosing. The maximum allowable dosage is four doses within a 24-hour period.

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

Healthcare professionals should monitor patients for adherence to these guidelines to prevent the risk of overdose.

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) or within 2 weeks of discontinuing an MAOI. This includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease, as the combination may lead to serious adverse effects. If there is uncertainty about the presence of an MAOI in a prescription, a healthcare professional should be consulted.

• History of allergic reaction to this product or any of its ingredients, as this may result in severe allergic responses.

Warnings and Precautions

Severe liver damage may occur with the use of this product containing acetaminophen under certain conditions. Adults should not exceed 4,000 mg of acetaminophen within a 24-hour period. For children, the maximum is 5 doses in 24 hours. Caution is advised when this product is taken in conjunction with other medications containing acetaminophen. Additionally, adults consuming three or more alcoholic drinks daily while using this product are at increased risk for liver damage.

Acetaminophen may also lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare professionals should advise patients to consult a doctor if they experience a severe sore throat that persists for more than two days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting.

Before initiating treatment, patients should be encouraged to seek medical advice if they have any of the following conditions: liver disease, heart disease, thyroid disease, diabetes, high blood pressure, difficulty urinating due to an enlarged prostate gland, or a cough associated with excessive phlegm. Patients with a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, should also consult a healthcare provider. Furthermore, individuals taking the anticoagulant warfarin should discuss their use of this product with a doctor or pharmacist prior to use.

In cases of overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help without delay, regardless of the presence of symptoms.

Patients should discontinue use and contact their healthcare provider if they experience any of the following: increased nervousness, dizziness, or sleeplessness; worsening pain, nasal congestion, or cough lasting more than 5 days in children or 7 days in adults; fever that worsens or persists beyond 3 days; any signs of redness or swelling; the emergence of new symptoms; or a cough that recurs or is accompanied by a rash or headache lasting for an extended period. These symptoms may indicate a serious underlying condition requiring further evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the recommended dosage of acetaminophen, specifically if an adult takes more than 4,000 mg within a 24-hour period, a child takes more than 5 doses in 24 hours, or if the product is used concurrently with other medications containing acetaminophen. Additionally, adults who consume three or more alcoholic drinks daily while using this product are at increased risk for liver damage.

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.

A sore throat warning is also in place; 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 provider promptly.

Patients are advised to stop use and seek medical advice if they experience nervousness, dizziness, or sleeplessness. Additionally, if pain, nasal congestion, or cough worsens or lasts longer than five days in children or seven days in adults, or if fever worsens or lasts more than three days, medical consultation is recommended. Signs such as redness or swelling, the emergence of new symptoms, or a cough that returns or occurs with a rash or headache lasting longer than expected may indicate a serious condition requiring medical evaluation.

Before using this product, patients with pre-existing conditions such as liver disease, heart disease, thyroid disease, diabetes, high blood pressure, or urinary difficulties due to an enlarged prostate gland should consult a healthcare provider. Those experiencing a cough with excessive phlegm or a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, should also seek medical advice prior to use. Furthermore, patients taking the blood-thinning medication warfarin should consult a doctor or pharmacist before using acetaminophen.

Drug Interactions

Patients should exercise caution when using this product in conjunction with certain medications due to potential drug interactions.

Anticoagulants

• Warfarin: Co-administration with this blood-thinning medication may increase the risk of bleeding. It is advisable for patients to consult a healthcare professional prior to using this product if they are currently taking warfarin.

Monoamine Oxidase Inhibitors (MAOIs)

• Concurrent use with prescription MAOIs, which are commonly prescribed for depression, psychiatric disorders, or Parkinson’s disease, is contraindicated. Patients should not use this product while taking an MAOI or within 2 weeks of discontinuing an MAOI. If there is uncertainty regarding the presence of an MAOI in a prescription medication, it is recommended to seek guidance from a healthcare provider before use.

Packaging & NDC

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

Pediatric Use

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

Healthcare professionals should be aware of the critical nature of overdose situations in pediatric patients. Quick medical attention is essential for children, even if no signs or symptoms of overdose are immediately apparent.

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 individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

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 weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice 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 on 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 absence of guidance necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to using this medication. It is essential for individuals with liver disease to receive appropriate guidance, as their liver function may affect the drug's metabolism and overall efficacy. Monitoring of liver function may be necessary to ensure safe and effective use of the medication in this population.

Overdosage

In cases of overdosage, significant health risks are associated with the consumption of acetaminophen beyond the recommended limits.

Adult Overdosage An adult who ingests more than 4,000 mg of acetaminophen within a 24-hour period is at risk of experiencing severe liver damage. This threshold is critical, and healthcare professionals should monitor patients closely for symptoms of hepatotoxicity following such an overdose.

Pediatric Overdosage For children, the risk of severe liver damage arises if they take more than five doses of acetaminophen within a 24-hour timeframe. It is essential for healthcare providers to educate caregivers about the importance of adhering to dosing guidelines to prevent potential overdose.

Drug Interactions The concomitant use of acetaminophen with other medications that also contain acetaminophen can exacerbate the risk of severe liver damage. Healthcare professionals should be vigilant in reviewing a patient's medication history to identify any potential overlaps in acetaminophen content.

Alcohol Consumption Adults who consume three or more alcoholic drinks daily while using acetaminophen are at an increased risk of severe liver damage. It is advisable for healthcare providers to assess a patient's alcohol intake and provide appropriate counseling regarding the risks associated with concurrent use.

In the event of suspected overdosage, immediate medical attention is warranted. Healthcare professionals should initiate appropriate management procedures, which may include supportive care and monitoring of liver function tests, to mitigate the risk of serious complications.

Nonclinical Toxicology

There is currently no available information regarding teratogenic or non-teratogenic effects associated with the compound. Additionally, no data has been provided concerning nonclinical toxicology, including animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions. Reported symptoms include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

Additionally, it is recommended to stop use and consult a healthcare professional if any of the following occur: worsening fever or fever lasting more than three days, presence of redness or swelling, emergence of new symptoms, or recurrence of cough accompanied by rash or headache lasting longer than expected. These symptoms may indicate a serious underlying condition.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Patients should be informed not to use this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in their medications, they should be encouraged to consult a doctor or pharmacist.

It is important to instruct patients not to use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI within the past two weeks. Patients should be advised to check with their healthcare provider if they are unsure whether their prescription includes an MAOI.

Patients with a history of allergic reactions to this product or any of its ingredients should be cautioned against its use. Healthcare providers should also instruct patients to discontinue use and consult a doctor if they experience symptoms such as nervousness, dizziness, or sleeplessness.

Patients should be advised to stop using the product and seek medical advice if their pain, nasal congestion, or cough worsens or persists beyond 5 days for children or 7 days for adults. Additionally, they should be informed to consult a doctor if fever worsens or lasts more than 3 days, or if they notice any redness or swelling.

Patients should be made aware that new symptoms may arise, and they should seek medical advice if a cough returns or occurs alongside a rash or persistent headache, as these could 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, thyroid disease, diabetes, high blood pressure, or difficulty urinating due to an enlarged prostate gland.

Patients should also be advised to seek medical guidance if they have a cough accompanied by excessive phlegm or if they have a persistent or chronic cough related to smoking, asthma, chronic bronchitis, or emphysema. Furthermore, patients taking the blood-thinning medication warfarin should be instructed to consult a doctor or pharmacist before using this product.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers. It should be stored at a temperature range of 20-25°C (68-77°F). It is important to note that refrigeration is not recommended for this product. Proper storage conditions must be maintained to ensure the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally, with specific dosing guidelines based on age. Adults and children aged 12 years and older are advised to take 30 mL every 4 hours, while children aged 6 to under 12 years should take 15 mL every 4 hours. For children aged 4 to under 6 years, it is recommended to consult a doctor, and the medication should not be used in children under 4 years of age.

Clinicians should counsel patients regarding the use of this medication during pregnancy or breastfeeding, advising them to consult a health professional before use. It is essential to keep the medication out of reach of children. In the event of an overdose, patients should seek immediate medical assistance 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.

Drug Information (PDF)

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

View product document (PDF)