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 common cold and flu symptoms, including minor aches and pains, headache, sore throat, runny nose, sneezing, fever, and cough due to minor throat and bronchial irritation.

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

Dosage and Administration

Healthcare professionals should advise patients to adhere strictly to the recommended dosage and administration guidelines.

For adults and children aged 12 years and older, the recommended dosage is 30 mL every 6 hours, with a maximum of 6 doses within a 24-hour period. It is imperative that patients do not exceed the directed dosage.

For children under 12 years of age, the product is not recommended for use.

Patients should be instructed to measure the dosage exclusively with the dosing cup provided, as the use of any other dosing device may lead to inaccurate dosing.

Additionally, when patients are using other Daytime or Nighttime products, they must carefully read each label to ensure correct dosing and avoid potential overdosing.

Contraindications

Use of this product is contraindicated in the following situations:

Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric or emotional conditions, or Parkinson's disease, or within 2 weeks of discontinuing such medication. The combination may lead to serious adverse effects. If there is uncertainty regarding the presence of an MAOI in a prescription drug, consultation with a healthcare professional is advised.

Concurrent use with any other drug containing acetaminophen, whether prescription or nonprescription, is also contraindicated due to the risk of acetaminophen overdose. If there is doubt about the acetaminophen content of a medication, a healthcare professional should be consulted.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 4000 mg of acetaminophen within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of three or more alcoholic drinks daily while using this product.

Acetaminophen may also lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. Should any of these symptoms occur, 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 for more than two days, or is accompanied or followed by fever, headache, rash, nausea, or vomiting.

In the event of an overdose, which may result in 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 if no signs or symptoms are apparent.

General precautions should be taken prior to use. Patients should be advised to consult a doctor if they have any of the following conditions: liver disease, glaucoma, a cough associated with excessive phlegm, a chronic cough related to smoking, asthma, chronic bronchitis, emphysema, or difficulty urinating due to an enlarged prostate gland. Additionally, patients should seek guidance from a doctor or pharmacist if they are taking sedatives, tranquilizers, or the blood-thinning medication warfarin.

While using this product, patients may experience excitability, particularly in children, and marked drowsiness. It is recommended to avoid alcoholic beverages, and caution should be exercised when driving or operating machinery, as alcohol, sedatives, and tranquilizers may exacerbate drowsiness.

Patients should be instructed to stop taking the product and contact a healthcare provider if any of the following occur: pain or cough worsens or lasts more than seven days, new symptoms arise, fever worsens or persists for more than three days, redness or swelling is observed, or if a cough recurs or is accompanied by a rash or headache that lasts. These symptoms may indicate a serious condition requiring medical evaluation.

Side Effects

Severe liver damage may occur in patients who exceed 4000 mg of acetaminophen within a 24-hour period, use other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product. In clinical trials and postmarketing experiences, patients have reported severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. If any of these symptoms occur, patients should discontinue use and seek medical assistance immediately.

Patients are advised to consult a healthcare professional 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. The use of this product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of stopping such medication. Additionally, patients should not use this product in conjunction with any other drug containing acetaminophen.

Patients with liver disease, glaucoma, excessive phlegm, chronic cough, or difficulty urinating due to an enlarged prostate gland should seek medical advice before using this product. Furthermore, individuals taking sedatives, tranquilizers, or the blood-thinning medication warfarin should also consult a healthcare provider prior to use.

While using this product, patients may experience excitability, particularly in children, and marked drowsiness. It is recommended to avoid alcoholic beverages, as well as to exercise caution when driving or operating machinery, due to the potential for increased drowsiness when combined with alcohol, sedatives, or tranquilizers.

Patients should discontinue use and consult a doctor if pain or cough worsens or persists for more than seven days, if new symptoms arise, if fever worsens or lasts more than three days, if redness or swelling is present, or if a cough recurs with a rash or headache that lasts. These symptoms may indicate a serious condition.

An overdose of this product may lead to liver damage. In the event of an overdose, patients should seek medical help or contact a Poison Control Center immediately, as prompt medical attention is critical for both adults and children, even if no signs or symptoms are initially apparent.

Drug Interactions

Acetaminophen has been identified to interact with several medications, necessitating careful consideration and monitoring during concurrent use.

Anticoagulants Acetaminophen may enhance the anticoagulant effect of warfarin, potentially increasing the risk of bleeding. It is advised to monitor the International Normalized Ratio (INR) closely in patients who are prescribed both acetaminophen and warfarin to ensure safe therapeutic levels.

Alcohol Concurrent use of acetaminophen and alcohol may elevate the risk of liver damage. It is recommended that patients avoid alcoholic beverages while using acetaminophen to mitigate this risk.

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 product. When administered to children aged 12 years and older, the recommended dosage is 30 mL every 6 hours. Caution is advised as excitability may occur, particularly in pediatric patients. Additionally, marked drowsiness has been reported. In the event of an overdose, it is crucial to seek medical assistance or contact a Poison Control Center (1-800-222-1222) immediately, as prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments or safety concerns. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy 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 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.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. Severe liver damage may occur if patients exceed 4000 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.

It is advised that patients with a history of liver disease consult a healthcare professional prior to use. The risk of liver damage increases significantly with the intake of doses exceeding the recommended amount, and in the event of an overdose, immediate medical assistance should be sought. Patients are encouraged to contact a Poison Control Center at 1-800-222-1222 without delay, as prompt medical attention is crucial 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 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.

Recommended Actions In the case of suspected overdose, immediate medical assistance should be sought. Healthcare providers are advised to contact a Poison Control Center at 1-800-222-1222 for guidance. Prompt intervention is crucial, as quick medical attention can mitigate the risks associated with overdose for both adults and children, even in the absence of noticeable symptoms.

Management Procedures Upon recognition of an overdose, healthcare professionals should initiate appropriate management protocols, which may include monitoring liver function and providing supportive care as necessary. The importance of timely intervention cannot be overstated, as it plays a critical role in the overall outcome for the patient.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use.

Excitability has been observed, particularly in pediatric populations. Additionally, marked drowsiness may occur, which can be exacerbated by the concurrent use of alcohol, sedatives, and tranquilizers.

No specific information regarding nonclinical toxicology or animal pharmacology and toxicology is available in the insert.

Postmarketing Experience

Postmarketing experience has identified several adverse events associated with acetaminophen use, reported voluntarily or through surveillance programs. Severe skin reactions have been noted, with symptoms including skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

Additionally, excitability has been observed, particularly in pediatric populations. Marked drowsiness is another reported effect, which may be exacerbated by the concurrent use of alcohol, sedatives, or tranquilizers.

Healthcare professionals are advised to instruct patients to discontinue use and consult a doctor if any of the following occur: worsening pain or cough lasting more than 7 days, the emergence of new symptoms, fever worsening or persisting beyond 3 days, presence of redness or swelling, or recurrence of cough accompanied by rash or headache lasting. These symptoms may indicate a serious condition.

Furthermore, taking more than the recommended dose can lead to liver damage. In cases of overdose, immediate medical attention is crucial, and individuals should contact a Poison Control Center (1-800-222-1222) without delay, even if no signs or symptoms are apparent.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. Patients should be informed not to use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI drug within the last two weeks. If patients are uncertain whether their prescription medication contains an MAOI, they should be encouraged to consult with their doctor or pharmacist.

It is important to instruct patients not to use this product in conjunction with any other medication containing acetaminophen, whether prescription or nonprescription. Patients should be advised to seek clarification from their healthcare provider if they are unsure about the presence of acetaminophen in their other medications.

Patients should be counseled to discontinue use and consult a doctor if their pain or cough worsens or persists for more than seven days. They should also be instructed to stop use and seek medical advice if new symptoms arise, if fever worsens or lasts more than three days, or if there is any redness or swelling. Additionally, patients should be made aware that if their cough returns or occurs with a rash or persistent headache, they should seek medical attention, as these may indicate a serious condition.

When using this product, patients should be informed that excitability may occur, particularly in children, and that marked drowsiness may also be a side effect. They should be cautioned against consuming alcoholic beverages while using this product, as well as being careful when driving or operating machinery due to the potential for drowsiness. Patients should be made aware that the combination of this product with alcohol, sedatives, or tranquilizers may enhance drowsiness.

Patients with liver disease, glaucoma, or a cough associated with excessive phlegm should be advised to consult a doctor before using this product. Additionally, those with breathing problems or chronic coughs related to smoking, asthma, chronic bronchitis, or emphysema should seek medical advice prior to use. Patients experiencing difficulty urinating due to an enlarged prostate gland should also consult their healthcare provider. Lastly, patients taking sedatives, tranquilizers, or the blood-thinning medication warfarin should be encouraged to discuss their use of this product with their doctor or pharmacist.

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 20-25°C (68-77°F). Refrigeration is not recommended, 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

The medication is administered orally, with a recommended dosage of 30 mL every 6 hours for adults and children aged 12 years and older. It is contraindicated for children under 12 years of age. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. 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 experience.

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.

View product document (PDF)