Circle K Nighttime 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 sore throat, headache, minor aches and pains, fever, runny nose, sneezing, and cough due to minor throat and bronchial irritation.

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage guidelines. For adults and children aged 12 years and older, the prescribed dosage is 2 softgels taken with water every 6 hours, not to exceed 4 doses within a 24-hour period. 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.

For children under 12 years of age, the use of this product is not recommended. Additionally, when utilizing other Daytime or Nighttime products, healthcare professionals should advise patients to carefully read each label to confirm appropriate dosing and avoid potential overdose.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be used in conjunction with any other medication 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.

Additionally, the product is contraindicated 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 any doubt about the presence of an MAOI in a prescription medication, a healthcare professional should be consulted prior to use.

Patients are also advised not to exceed the recommended dosage and to avoid the consumption of alcoholic beverages 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.

Exceeding the recommended dosage can result in liver damage. In cases of overdose, immediate medical attention is crucial; patients should contact a Poison Control Center at 1-800-222-1222, regardless of whether symptoms are present.

General precautions include the following: patients should not use this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a doctor or pharmacist is advised.

This product should not be used by individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of discontinuing such medication. Patients should verify with a healthcare provider if they are unsure whether their prescription includes an MAOI.

Before using this product, patients should seek medical advice if they have liver disease, glaucoma, difficulty urinating due to an enlarged prostate, or chronic respiratory conditions such as asthma, chronic bronchitis, or emphysema. Additionally, patients taking blood thinners like warfarin or those on sedatives or tranquilizers should consult a healthcare professional prior to use.

While using this product, patients must adhere to the recommended dosage. Notably, excitability may occur, particularly in children. Alcoholic beverages should be avoided, as marked drowsiness may result from the product's use, which can be exacerbated by alcohol, sedatives, and tranquilizers. Caution is advised when driving or operating machinery.

Patients should discontinue use and contact a healthcare provider if pain or cough worsens or persists beyond seven days, if fever worsens or lasts more than three days, if redness or swelling occurs, if new symptoms arise, or if a cough recurs with a rash or headache lasting longer than expected, 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 clinical settings, it is crucial for patients to adhere to recommended dosages to mitigate the risk of overdose, which can lead to significant liver injury. In the event of an overdose, immediate medical assistance should be sought, and patients are advised to contact a Poison Control Center (1-800-222-1222) without delay, as prompt intervention is essential for both adults and children, even in the absence of symptoms.

Patients may experience severe skin reactions, including symptoms such as skin reddening, blisters, and rash. Should any of these reactions occur, it is imperative to discontinue use and seek medical help immediately. Additionally, 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 professional promptly.

Patients with liver disease, glaucoma, difficulty urinating due to an enlarged prostate gland, or chronic respiratory conditions such as asthma, chronic bronchitis, or emphysema should seek medical advice before using this product. Furthermore, individuals taking blood thinners like warfarin or those on sedatives or tranquilizers should also consult a healthcare provider prior to use.

While using this product, patients should not exceed the recommended dosage, as excitability may occur, particularly in children. Marked drowsiness is a potential side effect, which may be exacerbated by the consumption of alcohol, sedatives, or tranquilizers. Caution is advised when driving or operating machinery.

Patients are advised to discontinue use and consult a doctor if pain or cough worsens or persists beyond seven days, if fever worsens or lasts more than three days, if redness or swelling is observed, if new symptoms arise, or if a cough recurs with a rash or headache lasting longer than expected, as these may indicate a serious condition.

Drug Interactions

Acetaminophen has the potential to increase the risk of liver damage when used concurrently with other medications containing acetaminophen or in individuals consuming three or more alcoholic beverages daily. It is advised that healthcare providers monitor liver function in patients who are at risk due to these factors.

Dextromethorphan may enhance the sedative effects of concomitant use with sedatives or tranquilizers, leading to increased drowsiness. Caution is recommended when prescribing these medications together, and dosage adjustments may be necessary based on the patient's response.

Additionally, acetaminophen should not be administered in conjunction with a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of discontinuing an MAOI, due to the potential for serious interactions. Monitoring for adverse effects is advised in patients who have recently stopped MAOI therapy.

Packaging & NDC

Below are the non-prescription pack sizes of Circle K Nighttime Cold and Flu (acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate). 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 6 hours, with a maximum of 4 doses in a 24-hour period.

Healthcare professionals should be aware that excitability may occur, particularly in children. In the event of an overdose, prompt medical attention is essential for both adults and pediatric patients, even if no signs or symptoms are immediately apparent.

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. 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 patients exceed 4,000 mg of acetaminophen within a 24-hour period, take this product in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

It is advised that patients with a history of 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, 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 if no signs or symptoms of overdose are apparent.

Overdosage

In cases of overdosage, the ingestion of more than the recommended dose may lead to significant liver damage. It is imperative that healthcare professionals remain vigilant regarding the potential severity of such incidents.

Recommended Actions In the event of an overdose, immediate medical assistance should be sought. Healthcare providers are advised to contact a Poison Control Center at 1-800-222-1222 without delay. Prompt intervention is crucial, as the risk of complications can escalate rapidly.

Symptoms and Management It is important to note that symptoms may not be immediately apparent. Therefore, quick medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms. Continuous monitoring and appropriate management strategies should be implemented to mitigate the risks associated with overdosage.

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

No specific postmarketing experience details have been reported in the available data. As such, there are no additional adverse events or rare case reports to summarize at this time.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. Patients should be instructed 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 important to inform patients that they should not use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI within the last two weeks. Patients should be advised to ask their healthcare provider if they are unsure whether their prescription medication contains an MAOI.

Patients should be instructed to discontinue use and seek medical advice if their pain or cough worsens or persists for more than 7 days, if their fever worsens or lasts more than 3 days, or if they notice any redness or swelling. They should also be advised to stop use and consult a doctor if new symptoms arise or if a cough returns, especially if accompanied by a rash or headache that lasts, as these may indicate a serious condition.

When using this product, patients should be cautioned not to exceed the recommended dosage. They should be made aware that excitability may occur, particularly in children, and that marked drowsiness may be a side effect. Patients should avoid consuming alcoholic beverages while using this product, as alcohol, sedatives, and tranquilizers may enhance drowsiness.

Patients should be advised to exercise caution when driving a motor vehicle or operating machinery due to the potential for drowsiness. Additionally, patients should be encouraged to consult a doctor before using this product if they have liver disease, glaucoma, difficulty urinating due to an enlarged prostate gland, or any breathing problems or chronic coughs, such as those associated with smoking, asthma, chronic bronchitis, or emphysema. They should also seek medical advice if they have a cough that produces excessive phlegm.

Finally, patients should be instructed to consult a doctor or pharmacist before using this product if they are taking the blood-thinning medication warfarin or if they are using sedatives or tranquilizers.

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 15-30°C (59-86°F) to maintain its efficacy. Care should be taken to avoid exposure to excessive heat, as this 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

Patients aged 12 years and older are advised to take 2 softgels orally with water every 6 hours as needed. Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding. Additionally, it is important to keep the medication out of reach of children. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

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

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