Circle K Daytime Cold and Flu

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 minor aches and pains, headache, sore throat, nasal congestion, fever, and cough due to minor throat and bronchial irritation.

There are no teratogenic or nonteratogenic effects mentioned in the available data.

Dosage and Administration

Patients should adhere strictly to the recommended dosage to avoid the risk of overdose. 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 two softgels taken with water every four hours. It is imperative that the softgels are swallowed whole; they must not be crushed, chewed, or dissolved to ensure proper release and absorption of the medication.

This product is not intended for use in children under 12 years of age. When utilizing other Daytime or Nighttime products, it is essential for patients to carefully read each label to confirm appropriate dosing and avoid exceeding the maximum dosage.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, is prohibited 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 should not be used in patients 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, or Parkinson's disease. If there is uncertainty about the presence of an MAOI in a prescription medication, a healthcare professional should be consulted prior to use.

• Users must adhere to the recommended dosage and should not exceed it while using this product.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 4,000 mg of acetaminophen within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of three or more alcoholic beverages daily while using this product.

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 promptly 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.

It is critical to adhere to the recommended dosage, as exceeding this can result in liver damage. In cases of overdose, immediate medical attention is necessary; patients should contact a Poison Control Center at 1-800-222-1222 without delay, as rapid intervention is essential for both adults and children, even in the absence of noticeable symptoms.

General precautions should be taken when considering the use of this product. Patients should be advised to consult a healthcare provider prior to use if they have any of the following conditions: liver disease, diabetes, heart disease, thyroid disease, high blood pressure, difficulty urinating due to an enlarged prostate gland, or a persistent or chronic cough associated with smoking, asthma, or emphysema. Additionally, patients should seek guidance from a doctor or pharmacist if they are currently taking the anticoagulant warfarin.

Patients must not exceed the recommended dosage while using this product.

Healthcare professionals should instruct patients to discontinue use and seek medical advice if any of the following occur: pain, cough, or nasal congestion worsens or persists beyond seven days; symptoms of nervousness, dizziness, or sleeplessness arise; fever worsens or lasts more than three days; redness or swelling is observed; new symptoms develop; or if a cough recurs or is accompanied by a rash or headache that lasts, as these may indicate a serious condition.

Side Effects

Severe liver damage may occur in patients who exceed 4,000 mg of acetaminophen within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product. In cases of overdose, it is imperative for patients to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222), as prompt intervention is crucial for both adults and children, even in the absence of noticeable symptoms.

Patients should be aware that acetaminophen may lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. If any of these symptoms occur, it is essential to discontinue use and seek medical help immediately.

In instances of severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients are advised to consult a healthcare professional promptly.

Patients should also discontinue use and consult a doctor if they experience worsening pain, cough, or nasal congestion lasting more than seven days; nervousness, dizziness, or sleeplessness; fever that worsens or lasts more than three days; redness or swelling; new symptoms; or if a cough recurs or occurs alongside a rash or headache that persists. These symptoms may indicate a serious underlying condition.

It is critical to adhere to the recommended dosage to avoid the risk of liver damage.

Drug Interactions

Acetaminophen has notable interactions that warrant careful consideration.

When acetaminophen is used concurrently with other medications containing acetaminophen, there is an increased risk of liver damage. This risk is further heightened in individuals who consume three or more alcoholic beverages daily. It is advisable to avoid the concomitant use of multiple acetaminophen-containing products and to limit alcohol intake to mitigate this risk.

Additionally, the co-administration of acetaminophen with warfarin may elevate the risk of bleeding. In such cases, it is essential to monitor the International Normalized Ratio (INR) closely to ensure safe and effective anticoagulation management. Adjustments to warfarin dosage may be necessary based on INR results.

Packaging & NDC

Below are the non-prescription pack sizes of Circle K Daytime Cold and Flu (acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For adolescents aged 12 years and older, the recommended dosage is 2 softgels taken with water every 4 hours, with a maximum of 4 doses within a 24-hour period.

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. The potential risks and benefits must be carefully considered, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to discuss their individual circumstances with a healthcare provider 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 should consult a healthcare professional prior to use, particularly if they experience difficulties urinating due to an enlarged prostate gland. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the degree of impairment.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. Severe liver damage may occur if patients exceed 4,000 mg of acetaminophen in a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

It is recommended that patients with known liver disease consult a healthcare professional prior to use. Adherence to the recommended dosage is crucial, as exceeding this dosage can lead to significant liver damage. In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Overdosage

In cases of overdosage, the potential for liver damage increases significantly when the recommended dose is exceeded. It is imperative that healthcare professionals remain vigilant regarding the signs and symptoms of overdose, as these may not always be immediately apparent.

In the event of an overdose, it is crucial to seek medical assistance promptly. Healthcare providers should advise patients or caregivers to contact a Poison Control Center at 1-800-222-1222 without delay. Quick medical intervention is essential for both adults and children, even in the absence of noticeable symptoms.

Timely management can mitigate the risks associated with overdosage and improve patient outcomes. Therefore, healthcare professionals should emphasize the importance of immediate action in such situations.

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

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. 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 be encouraged to consult a doctor or pharmacist.

It is crucial to inform patients that they should not use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the last two weeks. Patients should be advised to check with their healthcare provider or pharmacist if they are unsure whether their prescription medication contains an MAOI.

Patients should be instructed to stop using the product and seek medical advice if their pain, cough, or nasal congestion worsens or persists for more than seven days. Additionally, they should be made aware that they need to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. If fever worsens or lasts more than three days, or if redness or swelling occurs, patients should also be advised to stop use and contact their healthcare provider. They should be informed to seek medical attention if new symptoms arise or if a cough returns or occurs with a rash or headache that persists, as these may indicate a serious condition.

Patients must be reminded not to exceed the recommended dosage while using this product. It is important for healthcare providers to ask patients about their medical history and advise them to consult a doctor before use if they have liver disease, diabetes, heart disease, thyroid disease, high blood pressure, or trouble urinating due to an enlarged prostate gland. Patients with a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, should also be encouraged to seek medical advice before using this product. Furthermore, patients should be advised to consult a doctor if they have a cough that occurs with excessive phlegm (mucus). Lastly, those taking the blood-thinning medication warfarin should be instructed to speak with 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 15° to 30°C (59° to 86°F) to maintain its efficacy. Care should be taken to avoid exposure to excessive heat, which may compromise the integrity of the product. Proper storage conditions are crucial for ensuring the quality and safety of the product throughout its shelf life.

Additional Clinical Information

The medication is administered orally, with adults and children aged 12 years and older instructed to take 2 softgels with water every 4 hours, ensuring they are swallowed whole without crushing, chewing, or dissolving. It is contraindicated for children under 12 years of age.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding and to keep the medication out of reach of children. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)