Daytime Cold and Flu Relief, 24-7 Life by 7-Eleven

Description

No description information is available for the drug.

Uses and Indications

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

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

Dosage and Administration

For adults and children aged 12 years and over, the recommended dosage is 30 mL administered every 4 hours as needed. For children aged 6 to under 12 years, the appropriate dosage is 15 mL every 4 hours.

It is imperative that the maximum dosage is not exceeded; patients should not take more than the directed amount. The provided dose cup must be used for accurate measurement. Additionally, no more than 4 doses should be taken within a 24-hour period.

Children under 6 years of age should not use this medication.

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, which contains acetaminophen, under the following circumstances: if an adult consumes more than 4,000 mg of acetaminophen within a 24-hour period; if a child takes more than 5 doses in 24 hours; if it is taken concurrently with other medications containing acetaminophen; or if an adult consumes 3 or more alcoholic drinks daily while using this product.

Acetaminophen may also cause 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.

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

This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in another medication, consultation with a doctor or pharmacist is recommended. Additionally, this product should not be used by individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such medication. Individuals with a known allergy to this product or any of its ingredients should also refrain from use.

Healthcare professionals should advise patients to consult a doctor before using this product if they have any of the following conditions: difficulty urinating due to prostate enlargement, a cough that produces excessive phlegm, a persistent or chronic cough associated with smoking, asthma, or emphysema, heart disease, diabetes, thyroid disease, liver disease, or high blood pressure. Furthermore, patients taking the anticoagulant warfarin should seek guidance from a doctor or pharmacist prior to use.

While using this product, it is crucial not to exceed the recommended dosage. In the event of an overdose, immediate medical attention should be sought, or contact with a Poison Control Center is essential, as prompt intervention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

Patients should discontinue use and contact their healthcare provider if they experience nervousness, dizziness, or sleeplessness; if fever worsens or persists beyond 3 days; if redness or swelling occurs; if new symptoms arise; or if pain, nasal congestion, or cough worsens or lasts longer than 5 days in children or 7 days in adults. Additionally, if a cough recurs or is accompanied by a rash or headache that persists, these may indicate a serious condition requiring medical evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the recommended dosage of acetaminophen. Specifically, adults should not take more than 4,000 mg of acetaminophen within a 24-hour period, while children should not exceed 5 doses 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 three 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 of such reactions may include skin reddening, blisters, and rash. In the event of a skin reaction, patients are advised to discontinue use immediately and seek medical assistance.

Patients are also instructed to stop use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Additionally, if fever worsens or persists for more than three days, or if redness or swelling occurs, medical advice should be sought. New symptoms that arise, or if pain, nasal congestion, or cough worsens or lasts beyond five days in children or seven days in adults, warrant consultation with a healthcare provider. A return of cough or its occurrence alongside a rash or headache that persists may indicate a serious condition, necessitating prompt medical evaluation.

Drug Interactions

Patients taking warfarin, a blood-thinning medication, should consult with a healthcare professional prior to using this drug. The interaction between this medication and warfarin may necessitate careful monitoring of coagulation parameters to avoid potential adverse effects. Adjustments to the dosage of either drug may be required based on clinical judgment and patient response.

Packaging & NDC

Below are the non-prescription pack sizes of Daytime Cold and Flu Relief, 24-7 Life by 7-Eleven (acetaminophen, dextromethorphan hbr, phenylephrine hcl solution). 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 under 6 years, the use of this medication is not recommended. In contrast, adults and children aged 12 years and older may receive 30 mL every 4 hours.

Healthcare professionals should be aware of the liver warning associated with this medication, which indicates that a child should not take more than 5 doses within a 24-hour period. It is crucial to keep this medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, and contacting a Poison Control Center is advised. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially observed.

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. It is important to assess the potential risks and benefits associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the fetus.

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 not been specifically addressed in the prescribing information regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the absence of detailed guidance 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 be advised of the potential risks associated with the use of this product, which contains acetaminophen. Severe liver damage may occur if the following conditions are met: an adult consumes more than 4,000 mg of acetaminophen within a 24-hour period, a child takes more than 5 doses in a 24-hour period, the product is taken concurrently with other medications containing acetaminophen, or an adult consumes 3 or more alcoholic drinks daily while using this product.

It is recommended that patients with liver disease consult a healthcare professional prior to using this product to assess the appropriateness of treatment and to discuss any necessary dosage adjustments or monitoring requirements.

Overdosage

Severe liver damage is a significant risk associated with acetaminophen overdose. For adults, the threshold for potential harm is exceeded when more than 4,000 mg of acetaminophen is ingested within a 24-hour period. In pediatric patients, the risk of severe liver damage arises if a child takes more than five doses of acetaminophen in the same timeframe.

In the event of an overdose, it is imperative to seek medical assistance immediately or contact a Poison Control Center. Prompt medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms. Early recognition and management of acetaminophen overdose can significantly mitigate the risk of severe liver injury.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

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 product out of reach of children to prevent accidental ingestion. In the event of an overdose, it is crucial for patients to seek medical help or contact a Poison Control Center immediately, 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 product in conjunction with any other medications 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 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 with a history of allergic reactions to this product or any of its ingredients should be advised against its use. Additionally, they should be instructed to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness.

Patients should also be informed to stop using the product and seek medical advice if their fever worsens or persists for more than three days, if they notice any redness or swelling, or if new symptoms arise. They should be cautioned to stop use and consult a doctor if pain, nasal congestion, or cough worsens or lasts longer than five days in children or seven days in adults. Furthermore, patients should be advised to seek medical attention if a cough returns or occurs alongside a rash or persistent headache, as these may indicate a serious condition.

When using this product, patients must not exceed the recommended dosage. Healthcare providers should encourage patients to consult a doctor before use if they have difficulty urinating due to prostate enlargement, a cough accompanied by excessive phlegm, a persistent or chronic cough related to smoking, asthma, or emphysema, or if they have any of the following conditions: heart disease, diabetes, thyroid disease, liver disease, or high blood pressure. Lastly, patients taking the blood-thinning medication warfarin should be advised to consult a doctor or pharmacist before using this product.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. It should be stored at a controlled room temperature of 25°C (77°F), with permissible excursions between 15°C and 30°C (59°F and 86°F). It is essential to adhere to the expiration date indicated on the package to ensure product efficacy and safety.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a healthcare professional prior to use. It is essential to keep the medication out of reach of children. In the event of an overdose, patients should seek medical assistance or contact a Poison Control Center immediately, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Drug Information (PDF)

This file contains official product information for Daytime Cold and Flu Relief, 24-7 Life by 7-Eleven, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)