Kids Multi Symptom Cold and Flu

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary reduction of fever and the relief of common cold and flu symptoms, including minor aches and pains, headache, cough due to minor throat and bronchial irritation, and sore throat. Additionally, it is indicated for controlling the impulse to cough, thereby assisting children in achieving restful sleep.

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

Dosage and Administration

Healthcare professionals should instruct patients to shake the medication well before each use. Dosing should be determined according to the age-specific chart provided below. For accurate dosing, it is essential to utilize the measuring cup included with the product; other dosing devices should not be used.

The recommended dosing intervals are every 4 hours while symptoms persist, with a maximum of 5 doses allowed within a 24-hour period.

Dosage by Age:

• For children aged 6 to under 12 years, the recommended dose is 10 mL every 4 hours.

• For children aged 4 to under 6 years, the recommended dose is 7.5 mL every 4 hours.

• The medication is not recommended for children under 4 years of age.

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.

• In pediatric 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 uncertainty about the presence of an MAOI in a child's medication regimen, a healthcare professional should be consulted prior to administration of this product.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the maximum daily dosage is exceeded. Specifically, healthcare professionals should advise caregivers that no more than five doses should be administered within a 24-hour period. Additionally, caution is warranted when this product is used concurrently with other medications containing acetaminophen.

Severe skin reactions have been associated with acetaminophen use. 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.

In cases of severe sore throat, particularly if it persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is essential.

General precautions should be observed prior to administration. Caregivers should be advised to consult a physician if the child has a history of liver disease, experiences a cough with excessive phlegm, or has a persistent or chronic cough, such as that associated with asthma. Furthermore, it is advisable to seek guidance from a healthcare professional or pharmacist if the child is concurrently taking the anticoagulant warfarin.

In the event of an overdose, immediate medical attention is critical. Caregivers should be instructed to contact a Poison Control Center at 1-800-222-1222, even if no symptoms are apparent.

Healthcare professionals should also counsel caregivers to discontinue use and consult a physician if the child’s pain or cough worsens or persists beyond five days, if fever worsens or lasts more than three days, if new symptoms arise, if redness or swelling is observed, or if a cough recurs alongside a rash or headache. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

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

Severe liver damage may occur if the maximum daily amount of acetaminophen, which is more than 5 doses in 24 hours, is exceeded or if it is taken concurrently with other medications containing acetaminophen.

Acetaminophen may also cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, patients should discontinue use immediately and seek medical assistance.

Additionally, if a patient experiences a sore throat that is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, it is advised to consult a doctor promptly.

Patients should stop using the product and consult a healthcare professional if any of the following occur: pain or cough worsens or lasts more than 5 days; fever worsens or lasts more than 3 days; new symptoms arise; redness or swelling is observed; or if a cough recurs or occurs with a rash or headache that lasts. These symptoms may indicate a serious condition.

Before using this product, it is recommended that patients consult a doctor if they have liver disease, a cough that produces excessive phlegm, or a persistent or chronic cough, such as that associated with asthma. Furthermore, patients should seek advice from a doctor or pharmacist if they are taking the blood-thinning medication warfarin.

Drug Interactions

Acetaminophen has the potential to increase the risk of severe liver damage when used concurrently with other medications that also contain acetaminophen. It is advisable for healthcare providers to assess the total daily dose of acetaminophen from all sources to mitigate this risk.

In the case of dextromethorphan, it is contraindicated for use in children who are currently taking monoamine oxidase inhibitors (MAOIs) or within two weeks of discontinuing an MAOI. This interaction may lead to serious adverse effects and should be strictly avoided.

Additionally, acetaminophen may interact with warfarin, a commonly prescribed anticoagulant. This interaction necessitates careful monitoring of International Normalized Ratio (INR) levels to ensure safe and effective anticoagulation therapy. Adjustments to warfarin dosage may be required based on INR results and clinical judgment.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 6 to under 12 years may be administered 10 mL every 4 hours, while those aged 4 to under 6 years should receive 7.5 mL every 4 hours. The use of this medication is not recommended for children under 4 years of age.

Healthcare professionals should be aware of the liver warning associated with this medication. Severe liver damage may occur if a child takes more than 5 doses in a 24-hour period, which is the maximum daily amount when considering other medications containing acetaminophen.

Prior to administration, it is advised to consult a doctor if the child has liver disease, a cough that produces excessive phlegm, or a persistent or chronic cough, such as that associated with asthma. Additionally, consultation with a doctor or pharmacist is recommended if the child is concurrently taking the blood-thinning medication warfarin.

It is essential to keep this medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is critical even if no signs or symptoms are present.

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

The safety of this product during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare professional before use, as there may be potential risks to the fetus; however, specific studies or data regarding these risks are not provided in the prescribing information. No specific dosage modifications for pregnant individuals are mentioned. It is strongly advised that medical advice be sought prior to using this product during pregnancy to ensure the health and safety of both the patient and the fetus.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

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, particularly those with liver disease. It is advised that a healthcare professional be consulted prior to use in these individuals.

This product contains acetaminophen, which carries a risk of severe liver damage. Patients with compromised liver function must adhere strictly to the dosing guidelines, as exceeding 5 doses within a 24-hour period—regardless of the presence of other medications containing acetaminophen—can lead to significant hepatic injury. Therefore, careful monitoring of total acetaminophen intake is essential to prevent potential adverse effects on liver function.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt medical attention is crucial, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the management of an overdose may require specific interventions based on the substance involved and the clinical presentation of the patient. Continuous monitoring and supportive care may be necessary to address any potential complications that arise from the overdose.

It is essential to maintain a high index of suspicion for overdose in patients presenting with unexplained symptoms, as early recognition and intervention can significantly improve outcomes.

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 use of the compound in these contexts.

Postmarketing Experience

Postmarketing experience has revealed reports of severe skin reactions associated with acetaminophen. These reactions include symptoms such as skin reddening, blisters, and rash. These events have been reported voluntarily or identified through surveillance programs.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is important to inform patients 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.

Providers should caution against using this medication in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of stopping such a medication. Patients should be advised to seek clarification from a healthcare professional if they are unsure whether their child's prescription includes an MAOI.

Patients should be instructed to discontinue use and consult a doctor if pain or cough worsens or persists beyond five days, or if fever worsens or lasts more than three days. They should also be advised to seek medical attention if new symptoms arise, if there is any redness or swelling, or if a cough recurs or is accompanied by a rash or headache that lasts, as these may indicate a serious condition.

When using this product, patients must be reminded not to exceed the recommended dosage. It is also essential to encourage patients to consult a doctor before use if the child has liver disease, a cough associated with excessive phlegm, or a persistent or chronic cough, such as that which occurs with asthma. Additionally, patients should be advised to seek guidance from a doctor or pharmacist if the child is taking the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in various package configurations, with specific 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 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 dosing schedule of every 4 hours as long as symptoms persist. Clinicians should ensure that patients do not exceed a total of 5 doses within a 24-hour period.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)