Multi-Symptom Daytime Cold

Description

KIRKLAND Signature™ COLD MULTI-SYMPTOMS DAYTIME is a combination medication formulated to provide relief from multiple cold symptoms. Each Rapid Release Gelcap contains 325 mg of Acetaminophen, a pain reliever and fever reducer; 10 mg of Dextromethorphan HBr, a cough suppressant; and 5 mg of Phenylephrine HCl, a nasal decongestant.

The product is packaged under NDC 63981-560-46 and ITEM #532129. It is manufactured by LNK INTERNATIONAL, INC., located at 60 Arkay Drive, Hauppauge, NY 11788, USA, for Costco Wholesale Corporation, P.O. Box 34535, Seattle, WA 98124-1535, USA. For inquiries, contact 1-800-774-2678 or visit www.costco.com.

The product features a tamper-evident design, with a warning to not use if the carton is opened or if the blister unit is torn, broken, or shows any signs of tampering.

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms, including minor aches and pains, headache, nasal congestion, cough, sore throat, sinus congestion and pressure. It aids in clearing nasal passages and promotes nasal and sinus drainage. Additionally, this drug temporarily reduces fever.

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

Dosage and Administration

Adults and children aged 12 years and older are instructed to take 2 gelcaps every 4 hours as needed. It is imperative that they do not exceed a total of 12 gelcaps within a 24-hour period to avoid the risk of overdose.

For children under 12 years of age, this product is not recommended. The use of this adult formulation in this age group may result in administering a dose that exceeds the recommended limits, potentially leading to serious adverse effects, including liver damage.

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. If there is uncertainty regarding the presence of acetaminophen in a medication, 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 typically 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.

Exceeding the recommended dosage is also contraindicated.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients to adhere strictly to the maximum daily dosage of 12 gelcaps within a 24-hour period. Caution is warranted when this product is used in conjunction with other medications containing acetaminophen, as this may increase the risk of liver injury. Additionally, patients should be informed that consuming three or more alcoholic drinks daily while using this product can further elevate the risk of liver damage.

In cases of severe sore throat that persists for more than two days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting, patients should be instructed to consult a healthcare provider promptly.

Healthcare professionals must emphasize the importance of adhering to the recommended dosage to prevent overdose, which can lead to significant liver damage. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay. Quick medical intervention is crucial for both adults and children, even in the absence of noticeable symptoms.

Patients should be advised to discontinue use and seek medical advice if they experience nervousness, dizziness, or sleeplessness. Additionally, they should consult a healthcare provider if new symptoms arise, if pain, nasal congestion, or cough worsens or persists beyond seven days, if fever intensifies or lasts more than three days, or if redness or swelling occurs. A return of cough or the emergence of a rash or headache that lasts should also prompt immediate medical consultation, as these may indicate a serious underlying condition.

Side Effects

Patients using this product should be aware of potential adverse reactions, particularly those related to liver health and severe throat conditions. The product contains acetaminophen, which carries a significant risk of severe liver damage if the maximum daily dosage of 12 gelcaps is exceeded within a 24-hour period, if it is taken concurrently with other medications containing acetaminophen, or if consumed alongside three or more alcoholic drinks daily.

In addition to liver-related concerns, patients should be vigilant for symptoms indicating a serious condition. If a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, it is imperative to consult a healthcare professional promptly.

Patients are advised to discontinue use and seek medical advice if they experience nervousness, dizziness, or sleeplessness, if new symptoms arise, or if pain, nasal congestion, or cough worsens or lasts longer than seven days. Additionally, if fever worsens or persists beyond three days, or if redness or swelling is observed, medical consultation is recommended. A cough that recurs or is accompanied by a rash or headache lasting longer than expected should also prompt a discussion with a healthcare provider.

Before using this product, patients with pre-existing conditions such as liver disease, diabetes, heart disease, thyroid disease, or high blood pressure should consult a doctor. Those experiencing trouble urinating due to an enlarged prostate gland, persistent or chronic cough (such as that associated with smoking, asthma, or emphysema), or cough with excessive phlegm should also seek medical advice prior to use. Furthermore, individuals taking the blood-thinning medication warfarin should consult a doctor or pharmacist before using this product.

Drug Interactions

Concurrent use of this medication with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose and potential hepatotoxicity.

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, it should not be used for at least two weeks following the discontinuation of an MAOI to avoid serious interactions.

Patients taking the anticoagulant warfarin should consult a healthcare professional prior to using this medication. Monitoring of coagulation parameters may be warranted to ensure safe and effective use.

Packaging & NDC

Below are the non-prescription pack sizes of Multi-Symptom Daytime Cold (acetaminophen, dextromethorphan hbr, phenylephrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this adult product, as it may result in an overdose that exceeds the recommended dosage. Such an overdose poses a risk of liver damage. Therefore, caution is advised when considering the use of this product in younger populations.

Geriatric Use

Elderly patients may not require specific dosage adjustments when using this medication, as there are no safety concerns or dosage modifications indicated in the available data. However, healthcare providers should remain vigilant in monitoring this population for any potential adverse effects, given the general considerations associated with pharmacotherapy in geriatric patients. It is advisable to assess the overall health status and comorbidities of elderly patients to ensure optimal therapeutic outcomes.

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 on the excretion of this drug 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 not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. Severe liver damage may occur if patients exceed the maximum daily dosage of 12 gelcaps within a 24-hour period. Additionally, patients must avoid concomitant use with other medications containing acetaminophen, as this can further increase the risk of liver injury.

It is also advised that patients with compromised liver function limit their alcohol intake to fewer than three alcoholic drinks per day while using this product, as alcohol consumption can exacerbate the potential for liver damage. Regular assessment of liver function may be warranted in these patients to ensure safety and prevent adverse effects.

Overdosage

In cases of overdosage, significant health risks are associated with the consumption of this product, particularly concerning liver function.

Risk of Severe Liver Damage Taking more than 12 gelcaps within a 24-hour period, which is the maximum recommended daily dosage, can lead to severe liver damage. Healthcare professionals should be vigilant in assessing patients who may have exceeded this limit.

Additionally, the concomitant use of this product with other medications containing acetaminophen poses a further risk of severe liver damage. It is crucial for healthcare providers to inquire about all medications a patient is taking to prevent potential interactions that could exacerbate liver toxicity.

Alcohol Consumption Patients who consume three or more alcoholic drinks daily while using this product are also at an increased risk for severe liver damage. Healthcare professionals should advise patients on the dangers of combining alcohol with this medication and recommend monitoring for signs of liver impairment.

In the event of suspected overdosage, immediate medical attention is warranted. Healthcare providers should initiate appropriate management procedures, which may include supportive care and monitoring of liver function tests, as well as considering the need for further interventions based on the severity of the symptoms presented.

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 in these areas limits the understanding of the compound's safety profile in nonclinical settings.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions, such as anaphylaxis and angioedema. Severe skin reactions have also been noted, including Stevens-Johnson syndrome and toxic epidermal necrolysis. Instances of liver injury, including cases of acute liver failure, have been documented. Additionally, renal impairment, specifically acute kidney injury, has been reported.

Cardiovascular events, including hypertension and arrhythmias, have been observed. Gastrointestinal events, such as nausea and vomiting, have also been recorded. Furthermore, central nervous system effects, including dizziness and confusion, have been reported in the postmarketing setting.

Patient Counseling

Healthcare providers should advise patients about the potential risks associated with overdose, emphasizing that taking more than the recommended dose may lead to liver damage. In the event of an overdose, patients must seek medical help or contact a Poison Control Center immediately, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

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 important to instruct patients not to use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. Patients should be advised to check with a healthcare professional if they are unsure whether their prescription medication contains an MAOI.

Patients should be counseled to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, they should be advised to seek medical advice if new symptoms arise, or if pain, nasal congestion, or cough worsens or persists for more than seven days. If fever worsens or lasts more than three days, or if redness or swelling occurs, patients should also be instructed to stop use and contact a healthcare provider. Furthermore, patients should be made aware that a returning cough or one that occurs with a rash or persistent headache may indicate a serious condition, warranting immediate medical attention.

While using this product, patients must be reminded not to exceed the recommended dosage. Healthcare providers should encourage patients to consult a doctor before use if they have any of the following conditions: liver disease, diabetes, heart disease, thyroid disease, difficulty urinating due to an enlarged prostate gland, a persistent or chronic cough (such as that associated with smoking, asthma, or emphysema), high blood pressure, or a cough accompanied by excessive phlegm. Lastly, patients taking the blood-thinning medication warfarin should be advised to seek guidance from a doctor or pharmacist before using this product.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which can be found on the packaging. It is essential to store the product at a controlled room temperature, maintaining a range of 15° to 30°C (59° to 86°F).

For proper inventory management, healthcare professionals should refer to the end flap of the packaging for the expiration date and lot number, ensuring that the product is used within its designated timeframe.

Additional Clinical Information

The medication is administered orally, with specific dosing guidelines for different age groups. Adults and children aged 12 years and older are instructed to take 2 gelcaps every 4 hours, not exceeding 12 gelcaps within a 24-hour period. For children under 12 years, the product is not recommended, as it may lead to an overdose and potential liver damage.

Clinicians should counsel patients regarding 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. Patients should be made aware of the overdose warning, as exceeding the recommended dose can result in liver damage. In the event of an overdose, immediate medical assistance or contact with a Poison Control Center is essential, regardless of the presence of symptoms.

Drug Information (PDF)

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

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