Daytime Severe Cold and Flu

Description

774L-Kroger-Severe Cold and Flu Daytime is a pharmaceutical formulation designed to alleviate symptoms associated with cold and flu. The product is presented in a dosage form suitable for daytime use, ensuring effective relief while minimizing drowsiness. The specific composition and active ingredients are tailored to address common symptoms such as congestion, cough, and fever. The formulation is intended for use in adults and children over a specified age, following the recommended dosage guidelines.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. Specifically, it alleviates nasal congestion, sinus congestion and pressure, cough due to minor throat and bronchial irritation, minor aches and pains, headache, fever, and sore throat. Additionally, it reduces swelling of the nasal passages, temporarily restores freer breathing through the nose, promotes nasal and/or sinus drainage, and helps loosen phlegm (mucus) and thin bronchial secretions, thereby 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 take the medication only as directed and utilize the dose cup provided for accurate measurement.

For adults and children aged 12 years and older, the recommended dosage is 30 mL every 4 hours, with a maximum of 4 doses within a 24-hour period.

For children aged 6 to under 12 years, the dosage is 15 mL every 4 hours, also not to exceed 4 doses in a 24-hour timeframe.

For children aged 4 to under 6 years, it is advised to consult a physician for appropriate dosing recommendations.

The medication is not indicated for use in children under 4 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 2 weeks following the discontinuation of an MAOI. If there is uncertainty about whether a prescription medication contains an MAOI, a healthcare professional should be consulted prior to using this product.

• It is also advised not to exceed the recommended dosage when using 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 an adult exceeds 4 doses (30 mL each) within a 24-hour period, or if a child exceeds 4 doses (15 mL each) in the same timeframe. Additionally, caution is warranted when this product is taken concurrently with other medications containing acetaminophen. Patients who consume 3 or more alcoholic drinks daily while using this product are also at heightened risk for liver damage.

Acetaminophen has been associated with severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. Should any of these symptoms manifest, patients must be instructed to discontinue use immediately and seek medical assistance.

In cases of severe sore throat, particularly if it persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be advised to consult a physician without delay.

In the event of an overdose, immediate medical attention is essential. Patients should be instructed to contact a Poison Control Center (1-800-222-1222) or seek emergency medical help right away, as prompt intervention is critical for both adults and children, even in the absence of noticeable symptoms.

Patients should also be advised to discontinue use and contact their healthcare provider if they experience any of the following: 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 for more than 3 days; presence of redness or swelling; emergence of new symptoms; or recurrence of cough accompanied by rash or a headache that lasts.

Side Effects

Severe adverse reactions associated with this product include significant liver damage, which may occur if an adult exceeds 4 doses (30 mL each) within a 24-hour period, or if a child exceeds 4 doses (15 mL each) in the same timeframe. The risk of liver damage is heightened when this product 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 due to 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 immediate medical assistance.

Participants should also be advised to consult a healthcare professional if they experience a sore throat that is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting.

Common adverse reactions that warrant discontinuation of use and consultation with a doctor include 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 fever persists or worsens beyond 3 days, medical advice should be sought. The presence of redness or swelling, the emergence of new symptoms, or a cough that recurs or is accompanied by a rash or headache lasting longer than expected may indicate a serious condition.

Patients with pre-existing conditions such as liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or those experiencing difficulty urinating due to an enlarged prostate gland should consult a doctor prior to use. Individuals with a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, as well as those on a sodium-restricted diet, should also seek medical advice before using this product.

Furthermore, it is advisable for patients taking the blood-thinning medication warfarin to consult a doctor or pharmacist before using this product to avoid potential interactions.

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 and potential hepatotoxicity.

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric or emotional conditions, or Parkinson's disease, as well as for a period of two weeks following the discontinuation of an MAOI. The combination may lead to serious adverse effects, including hypertensive crises.

Patients taking the anticoagulant warfarin should consult a healthcare professional prior to using this medication. Monitoring of coagulation parameters may be necessary to ensure safe use and to avoid potential interactions that could affect bleeding risk.

Packaging & NDC

Below are the non-prescription pack sizes of Daytime Severe Cold and Flu (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, with a maximum of 4 doses (15 mL each) in a 24-hour period. 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.

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. 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 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 the safety of both the mother 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

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution when prescribing to patients with renal impairment, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

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 conditions are met:

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

• Children should not exceed 4 doses (15 mL each) in a 24-hour period, which is also the maximum daily amount for this product.

• Caution is advised if this product is taken concurrently with other medications containing acetaminophen, as this may increase the risk of liver damage.

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

Due to these risks, it is recommended that patients with compromised liver function consult a healthcare professional before using this product to ensure safe and appropriate use. Regular monitoring of liver function may be warranted in these patients.

Overdosage

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

Adult Overdosage An adult who ingests more than 4 doses (30 mL each) within a 24-hour period is at risk of experiencing severe liver damage. This dosage exceeds the maximum daily amount recommended for safe use of the product. Additionally, the concomitant use of this product with other medications containing acetaminophen can further exacerbate the risk of liver injury.

Pediatric Overdosage For children, the threshold for potential severe liver damage is similarly critical. Ingesting more than 4 doses (15 mL each) in a 24-hour timeframe poses a significant risk, as this also surpasses the maximum daily dosage advised for pediatric patients.

Alcohol Consumption Adults who consume 3 or more alcoholic beverages daily while using this product are advised to exercise caution, as this behavior may lead to severe liver damage. The interaction between alcohol and the active ingredients in the product can significantly heighten the risk of hepatotoxicity.

Healthcare professionals should monitor patients for symptoms of liver damage, which may include jaundice, abdominal pain, and elevated liver enzymes. In the event of suspected overdosage, immediate medical intervention is recommended to mitigate potential liver injury.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions: severe skin reactions, which may manifest as skin reddening, blisters, and rash. In the event of a skin reaction, it is advised that the use of the product be discontinued immediately and medical assistance be sought.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, it is crucial to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

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 medication 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 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 for children or 7 days for adults. If fever worsens or lasts more than 3 days, or if redness or swelling occurs, patients should also stop use and contact a healthcare professional. New symptoms or a cough that returns or occurs with a rash or headache that lasts should prompt patients to seek medical attention, as these may indicate a serious condition.

While using this product, patients must be reminded not to exceed the recommended dosage. 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 difficulty urinating due to an enlarged prostate gland. Patients should also be advised to seek medical advice if they have a cough accompanied by excessive phlegm or a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Furthermore, patients on a sodium-restricted diet or those taking the blood-thinning medication warfarin should consult a doctor or pharmacist before use.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It is essential to store the product at a temperature not exceeding 25℃. Refrigeration is not recommended. Proper storage conditions must be maintained to ensure 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 Daytime Severe Cold and Flu, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)