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

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms, including sore throat, nasal congestion, headache, minor aches and pains, 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 directed and must not exceed 4 doses within a 24-hour period.

Administration should be performed using only the dose cup provided to ensure accurate measurement. The product is not recommended for use in children under 6 years of age.

Contraindications

Use of this product is contraindicated in the following situations:

Patients should not use this product in conjunction 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.

The product is contraindicated in individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson’s disease. Patients should verify with a healthcare provider if they are unsure whether their prescription includes an MAOI.

Additionally, this product should not be used by individuals with a known allergy to it or any of its ingredients, as this may lead to serious allergic reactions.

Warnings and Precautions

This product contains acetaminophen, which carries significant risks for liver damage. Severe liver injury may occur if an adult consumes more than 4,000 mg of acetaminophen within a 24-hour period, if a child takes more than five doses in the same timeframe, if it is used concurrently with other medications containing acetaminophen, or if an adult consumes three or more alcoholic beverages daily while using this product.

Acetaminophen may also provoke severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of any 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 sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting.

General precautions should be taken prior to use. Patients should be instructed to seek medical advice 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. Additionally, patients taking the anticoagulant warfarin should consult a healthcare provider or pharmacist before using this product. It is crucial that patients do not exceed the recommended dosage.

In cases of overdose, immediate medical attention is necessary. Patients should be advised to contact a Poison Control Center or seek emergency medical help without delay, as prompt intervention is critical for both adults and children, even in the absence of noticeable symptoms.

Patients should discontinue use and contact a healthcare professional if they experience nervousness, dizziness, or sleeplessness; if fever worsens or persists beyond three days; if redness or swelling occurs; if new symptoms arise; or if pain, nasal congestion, or cough worsens or lasts longer than five days in children or seven days in adults. A recurrence of cough accompanied by rash or headache that persists should also prompt immediate medical consultation, as these may indicate a serious underlying condition.

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 the same timeframe, 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 that acetaminophen may 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 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 contact a doctor if they experience nervousness, dizziness, or sleeplessness, if fever worsens or lasts more than three days, if redness or swelling occurs, if new symptoms arise, or if pain, nasal congestion, or cough worsens or lasts beyond five days in children or seven days in adults. A return of cough or occurrence of cough with rash or headache that lasts should also prompt medical consultation, as these may indicate a serious condition.

Before using this product, patients should consult a doctor if they have difficulty urinating due to prostate gland enlargement, a cough that produces excessive phlegm, a persistent or chronic cough associated with smoking, asthma, or emphysema, or if they have a history of heart disease, diabetes, thyroid disease, liver disease, or high blood pressure.

Furthermore, patients taking the blood-thinning medication warfarin should seek advice from a doctor or pharmacist prior to use.

Drug Interactions

Patients taking warfarin, a blood-thinning medication, should consult 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 Relief, Cold and Flu, 24-7 Life by 7-Eleven (acetaminophen, dextromethorphan hbr, phenylephrine hcl solution). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

The product is indicated for use in pediatric patients aged 6 years and older. For children between the ages of 6 and under 12 years, the recommended dosage is 15 mL every 4 hours. The product is contraindicated in children under 6 years of age.

Healthcare professionals should be aware of the potential risk of severe liver damage in pediatric patients who exceed 5 doses within a 24-hour period. Additionally, if symptoms such as pain, nasal congestion, or cough worsen or persist beyond 5 days in children (or 7 days in adults), the product should be discontinued, and a healthcare provider should be consulted.

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 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 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 drug insert 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 exercise caution when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. The following considerations are essential for this patient population:

Severe liver damage may occur if an adult exceeds 4,000 mg of acetaminophen within a 24-hour period, or if a child takes more than 5 doses in the same timeframe. Additionally, the risk of liver damage increases if this product is taken concurrently with other medications containing acetaminophen or if an adult consumes 3 or more alcoholic drinks daily while using this product.

It is advised that patients with known liver disease consult a healthcare professional prior to using this product to assess the appropriateness of treatment and to discuss potential risks. Monitoring of liver function may be warranted in patients with compromised liver function to ensure safety and efficacy.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt medical attention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

Acetaminophen overdose can lead to severe liver damage, particularly if an adult ingests more than 4,000 mg within a 24-hour period. Healthcare professionals should be vigilant in assessing the patient's history and potential exposure to acetaminophen to determine the appropriate course of action.

Management of acetaminophen overdose typically involves the administration of N-acetylcysteine (NAC) as an antidote, which is most effective when given within 8 hours of ingestion. Continuous monitoring of liver function tests and supportive care may also be necessary, depending on the severity of the overdose and the patient's clinical status.

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

Reports of severe skin reactions, including skin reddening, blisters, and rash, have been received through voluntary reporting and surveillance programs. In cases where a skin reaction occurs, it is advised to discontinue use and seek medical assistance promptly.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children. In the event of an overdose, it is crucial 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 medication 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) for conditions such as depression, psychiatric disorders, or Parkinson’s disease, or for two weeks after discontinuing an MAOI. Patients should be encouraged to ask their healthcare provider 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. Healthcare providers should instruct patients to stop using the product and consult a doctor if they experience nervousness, dizziness, or sleeplessness.

Patients should also be informed to 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. Additionally, they should be advised 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. If a cough returns or occurs alongside a rash or persistent headache, patients should seek medical attention, as these may indicate a serious condition.

Healthcare providers should emphasize the importance of adhering to the recommended dosage and advise patients to consult a doctor before use if they have difficulty urinating due to an enlarged prostate gland, 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. Furthermore, 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 various package configurations, with specific NDC numbers available upon request. It should be stored at a controlled room temperature of 25°C (77°F). Temporary excursions are permitted 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 health 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 in the absence of noticeable signs or symptoms.

Drug Information (PDF)

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

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