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 symptoms associated with the common cold and influenza. Specifically, it alleviates minor aches and pains, headache, sore throat, nasal congestion, fever, sinus pressure, and cough due to minor throat and bronchial irritation.

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

Dosage and Administration

Adults and children aged 12 years and older are advised to take 30 mL every 4 hours as needed. For children aged 6 to under 12 years, the recommended dosage is 15 mL every 4 hours. It is important to consult a healthcare professional for children aged 4 to under 6 years, as specific dosing instructions should be obtained. The product is not recommended for use in children under 4 years of age.

Patients should not exceed 4 doses within a 24-hour period. It is essential to measure the dosage using only the dosing cup provided with the product; the use of any other dosing device is not recommended. The dosing cup should be kept with the product for convenience.

When using other Daytime or Nighttime products, healthcare professionals should advise patients to carefully read each label to ensure correct dosing and avoid potential overdosing.

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 use.

• Exceeding the recommended dosage while using this product is also contraindicated.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen, under the following circumstances: an adult taking more than 4 doses (30 mL each) within a 24-hour period, a child exceeding 4 doses (15 mL each) in the same timeframe, concurrent use with other medications containing acetaminophen, or if an adult consumes 3 or more alcoholic drinks daily while using this product.

Acetaminophen is also associated with the risk of severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. Should any of these symptoms manifest, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare professionals should advise patients to consult a doctor promptly if a sore throat is severe, persists beyond 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting.

In the event of an overdose, which may lead to liver damage, immediate medical help should be sought, or the Poison Control Center (1-800-222-1222) should be contacted. Quick medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

General precautions should be taken prior to use. Patients should be advised to consult a healthcare provider if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, 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. It is essential that the recommended dosage is not exceeded during the use of this product.

Patients should be instructed to stop taking the product and contact a healthcare professional if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or persists beyond 5 days in children or 7 days in adults; if fever worsens or lasts more than 3 days; if redness or swelling occurs; if new symptoms arise; 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 taking this product containing acetaminophen if the following conditions are met: an adult consumes more than 4 doses (30 mL each) within a 24-hour period, a child exceeds 4 doses (15 mL each) in the same timeframe, the product is taken concurrently with other medications containing acetaminophen, or an adult consumes 3 or more alcoholic drinks daily while using this product.

Patients should be aware of the potential for severe skin reactions associated with 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 medical assistance immediately.

In cases of severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, patients are advised to consult a healthcare professional promptly.

Patients should discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or lasts longer than 5 days in children or 7 days in adults; if fever worsens or lasts more than 3 days; if redness or swelling is observed; if new symptoms arise; or if a cough recurs or occurs with a rash or headache that persists, as these may indicate a serious condition.

An overdose of this product may lead to liver damage. Patients are urged to seek immediate medical help or contact a Poison Control Center (1-800-222-1222) if they suspect an overdose, even if no signs or symptoms are present, as prompt medical attention is critical for both adults and children.

Drug Interactions

Acetaminophen has several important drug interactions that should be considered to ensure patient safety and efficacy of treatment.

Pharmacodynamic Interactions:Acetaminophen is contraindicated in patients who are currently taking prescription monoamine oxidase inhibitors (MAOIs) or have taken them within the past two weeks. The combination may lead to significant adverse effects.

Pharmacokinetic Interactions:The concurrent use of acetaminophen with other medications containing acetaminophen can increase the risk of liver damage. Additionally, patients who consume three or more alcoholic drinks daily are at an elevated risk for liver toxicity when using acetaminophen.

Monitoring and Consultation:Patients taking warfarin should seek medical advice prior to using acetaminophen, as there is potential for interactions that may affect anticoagulation control. Regular monitoring of INR levels may be warranted in these patients to ensure therapeutic effectiveness and safety.

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 aged 6 to under 12 years may be administered 15 mL every 4 hours. For children aged 4 to under 6 years, it is advised to consult a doctor before use. The product is not recommended for children under 4 years of age.

Healthcare professionals should be aware of the liver warning associated with the use of this medication; if a child takes more than 4 doses of 15 mL each within a 24-hour period, medical advice should be sought. Additionally, caregivers should be instructed to stop use and consult a doctor if the child's pain, nasal congestion, or cough worsens or persists for more than 5 days.

In cases of overdose, prompt medical attention is critical for pediatric patients, even if no signs or symptoms 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. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient 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

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 lack of data 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, which contains acetaminophen. Severe liver damage may occur if the maximum daily dosage is exceeded. For adults, this is defined as more than 4 doses (30 mL each) within a 24-hour period, and for children, it is more than 4 doses (15 mL each) in the same timeframe. Additionally, the risk of liver damage increases if this product is taken concurrently with other medications containing acetaminophen or if the patient consumes 3 or more alcoholic drinks daily while using this product.

Patients with a history of liver disease are advised to consult a healthcare professional prior to use. It is crucial to adhere strictly to the recommended dosage to avoid the risk of overdose, which may lead to liver damage. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted without delay. Prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Overdosage

In the event of an overdose, the potential for liver damage increases significantly when the recommended dosage 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.

Immediate medical assistance is crucial. In cases of suspected overdose, healthcare providers should advise patients or caregivers to seek medical help without delay. Contacting a Poison Control Center at 1-800-222-1222 is recommended for further guidance and support.

Prompt intervention is essential for both adults and children, even in the absence of noticeable symptoms. The risk of serious complications necessitates a proactive approach to management, ensuring that appropriate medical care is administered as soon as possible.

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 limits the assessment of potential risks associated with the compound in these areas.

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 immediately and seek medical assistance.

Patient Counseling

Patients should be advised to keep this medication out of reach of children to prevent accidental ingestion. It is important to inform patients that they should not 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 with a doctor or pharmacist.

Patients should be cautioned against using this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. MAOIs are often prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. If patients are unsure whether their prescription includes an MAOI, they should seek guidance from a healthcare professional.

Patients should be instructed to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, they should stop using the product and seek medical advice if pain, nasal congestion, or cough worsens or persists beyond 5 days in children or 7 days in adults. If fever worsens or lasts more than 3 days, or if redness or swelling occurs, patients should also be advised to contact their healthcare provider. New symptoms that arise during treatment should prompt a discussion with a doctor.

Patients should be made aware that if a cough returns or occurs alongside a rash or persistent headache, these could indicate a serious condition, and they should seek medical attention. It is crucial to emphasize that patients must not exceed the recommended dosage while using this product.

Before initiating treatment, patients should be encouraged to consult a doctor 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. Furthermore, patients with a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, should also seek medical advice prior to use. If a cough is accompanied by excessive phlegm (mucus), patients should be advised to consult a healthcare professional. Lastly, patients taking the blood-thinning medication warfarin should discuss their use of this product with a doctor or pharmacist.

Storage and Handling

The product is supplied in specific packaging configurations, with relevant NDC numbers available upon request. It is essential to store the product at a temperature range of 20-25°C (68-77°F). Refrigeration is not permitted, as it may compromise the integrity of the product. Proper handling and storage conditions must be adhered to in order to maintain product efficacy and safety.

Additional Clinical Information

No further data are available.

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)