Severe Cold and Flu Plus Congestion

Description

KIRKLAND Signature COOL BLAST SEVERE COLD & FLU PLUS CONGESTION is a combination medication formulated to provide relief from multiple symptoms associated with cold and flu. The product contains the following active ingredients: Acetaminophen (325 mg), Dextromethorphan HBr (10 mg), Guaifenesin (200 mg), and Phenylephrine HCl (5 mg).

This formulation serves various therapeutic purposes, including pain relief, fever reduction, cough suppression, expectoration, and nasal decongestion. It is indicated for the alleviation of headache, fever, sore throat, minor aches and pains, chest congestion, thinned and loosened mucus, nasal congestion, sinus pressure, and cough.

The product is presented in the form of coated caplets, with a total of 168 caplets per package, each containing 112 day caplets. The product is manufactured by LNK INTERNATIONAL, INC., located at 60 Arkay Drive, Hauppauge, NY 11788, USA, for Costco Wholesale Corporation, 999 Lake Drive, Issaquah, WA 98027, USA. The National Drug Code (NDC) for this product is 63981-795-81.

A tamper evident warning is included, advising against use if the package is opened or if the blister unit is torn, broken, or shows any signs of tampering. Caution is advised to avoid taking daytime and nighttime products simultaneously. For more information, visit www.costco.com.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. Specifically, it alleviates nasal congestion, sore throat, minor aches and pains, headache, sinus congestion and pressure, and cough due to minor throat and bronchial irritation. Additionally, it reduces swelling of the nasal passages, temporarily lowers fever, and promotes freer breathing through the nose. The formulation also aids in nasal and/or sinus drainage and helps to loosen phlegm (mucus) and thin bronchial secretions, facilitating the clearance of mucus from the bronchial passageways and making coughs more productive.

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage. For adults and children aged 12 years and older, the prescribed dosage is 2 caplets taken with water every 4 hours, not to exceed 8 caplets within a 24-hour period.

For children under 12 years of age, it is advised to consult a physician for appropriate dosing recommendations.

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) or within 2 weeks of discontinuing an MAOI. This includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease, as the combination may lead to serious adverse effects. If there is uncertainty about the presence of an MAOI in a prescription, a healthcare professional should be consulted.

• History of allergic reaction to this product or any of its ingredients, as this may result in severe allergic responses.

Warnings and Precautions

This product contains acetaminophen, which carries significant risks that healthcare professionals must communicate to patients.

Liver Warning Severe liver damage may occur if the patient exceeds 4,000 mg of acetaminophen within a 24-hour period, uses other medications containing acetaminophen concurrently, or consumes three or more alcoholic drinks daily while using this product. It is crucial to monitor patients for signs of liver dysfunction, especially in those with pre-existing liver conditions.

Allergy Alert Acetaminophen may lead to severe skin reactions, which can manifest as blisters, rash, or skin reddening. If any of these symptoms occur, patients should be advised to discontinue use immediately and seek medical assistance.

Sore Throat Warning Patients experiencing a severe sore throat that persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, should be instructed to consult a physician promptly.

General Precautions Healthcare professionals should advise patients to consult a doctor before using this product if they have any of the following conditions: liver disease, diabetes, thyroid disease, heart disease, high blood pressure, difficulty urinating due to prostate enlargement, or a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, patients taking the anticoagulant warfarin should seek guidance from a healthcare provider or pharmacist prior to use.

Emergency Medical Help In the event of an overdose, it is imperative to seek emergency medical help or contact a Poison Control Center immediately. Prompt medical attention is essential for both adults and children, even if no symptoms are initially apparent.

Discontinuation of Use Patients should be instructed to stop taking this product and contact their healthcare provider if they experience nervousness, dizziness, or sleeplessness; if redness or swelling occurs; if new symptoms develop; or if pain, nasal congestion, or cough worsens or persists beyond seven days. Additionally, if fever worsens or lasts more than three days, or if a cough recurs with a rash or headache that lasts, these may indicate a serious condition requiring medical evaluation.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

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.

Additionally, acetaminophen may cause severe skin reactions, which can manifest as blisters, rash, or skin reddening. If any of these symptoms occur, patients are advised to discontinue use immediately and seek medical assistance.

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

Patients should stop using the product and consult a doctor if they experience nervousness, dizziness, or sleeplessness; if redness or swelling develops; if new symptoms arise; or if pain, nasal congestion, or cough worsens or lasts more than seven days. Additionally, if fever worsens or lasts more than three days, or if a cough recurs or occurs with a rash or headache that persists, these may indicate a serious condition requiring medical evaluation.

Before using this product, patients with liver disease, diabetes, thyroid disease, heart disease, high blood pressure, or difficulty urinating due to prostate enlargement should seek medical advice. Those with a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, or a cough that produces excessive phlegm, should also consult a healthcare provider.

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

Drug Interactions

Co-administration of this product with any other medication containing acetaminophen, whether prescription or nonprescription, is contraindicated. Patients should be advised to consult a healthcare professional if there is uncertainty regarding the presence of acetaminophen in other medications.

The use of this product is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of discontinuing such treatment. MAOIs are commonly prescribed for depression, psychiatric disorders, or Parkinson’s disease. Patients should seek guidance from a healthcare provider if they are unsure whether their prescription includes an MAOI.

Caution is advised when using this product in conjunction with warfarin, a blood-thinning medication. Patients should consult a healthcare professional prior to use to assess potential interactions and the need for monitoring.

Additionally, the concurrent use of this product with sedatives or tranquilizers warrants consultation with a healthcare provider. The combination of alcohol, sedatives, and tranquilizers may enhance drowsiness, and patients should be informed of this risk.

Packaging & NDC

Below are the non-prescription pack sizes of Severe Cold and Flu Plus Congestion (acetaminophen, dextromethorphan hbr, doxylamine succinate, guaifenesin, phenylephrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosage is 2 caplets taken with water every 4 hours, with a maximum of 8 caplets in a 24-hour period.

Caution is advised as excitability may occur, particularly in children. It is essential for both adults and pediatric patients to seek prompt medical attention, even in the absence of noticeable signs or symptoms.

Geriatric Use

There is no specific information available 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, 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 in these populations to ensure the safety of both the mother and the fetus or infant.

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. 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. It is critical that patients do not exceed 4,000 mg of acetaminophen within a 24-hour period. Additionally, patients should avoid concurrent use with other medications that contain acetaminophen and limit alcohol consumption to fewer than three alcoholic drinks per day while using this product.

Before initiating treatment, patients with known liver disease are advised to consult a healthcare professional. Monitoring of liver function may be warranted in these patients to ensure safety and efficacy during the course of therapy.

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 intervention is crucial for both adults and children, regardless of whether any signs or symptoms are apparent.

Healthcare professionals should be aware that the absence of symptoms does not preclude the possibility of serious complications arising from an overdose. Therefore, it is essential to monitor the patient closely and provide appropriate care as needed.

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 several adverse events reported voluntarily or through surveillance programs.

Severe skin reactions, including blisters, rash, and skin reddening, have been associated with acetaminophen use. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

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

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose, emphasizing that prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Patients should be instructed not to exceed the recommended dosage of the medication. It is important for healthcare providers to encourage patients to consult with a doctor prior to use if they have any of the following conditions: liver disease, diabetes, thyroid disease, heart disease, high blood pressure, difficulty urinating due to prostate gland enlargement, or a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, patients should be advised to seek medical advice if they experience a cough that produces excessive phlegm (mucus).

Furthermore, healthcare providers should recommend that patients consult with a doctor or pharmacist before using this medication if they are currently taking the blood-thinning medication warfarin, to ensure safety and avoid potential interactions.

Storage and Handling

The product is supplied in a tamper-evident package. It should not be used if the outer package is opened or if the blister is torn or broken.

Storage conditions require the product to be maintained at a temperature of 25°C (77°F), with permissible excursions between 15°-30°C (59°-86°F). For optimal integrity, it is essential to monitor storage conditions closely.

The expiration date and lot number can be found on the end flap of the packaging.

Additional Clinical Information

Patients aged 12 years and older are advised to take 2 caplets with water every 4 hours, while those under 12 years should consult a doctor for appropriate dosing. Clinicians should counsel patients on the importance of consulting a health professional if they are pregnant or breastfeeding. It is crucial to keep the medication out of reach of children. In the event of an overdose, patients must seek medical help or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even if no symptoms are apparent.

Drug Information (PDF)

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

View product document (PDF)