Cvs Childrens

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza, including minor aches and pains, headache, sore throat, and cough. Additionally, it is indicated for the temporary reduction of fever.

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

Dosage and Administration

This product is intended for pediatric use only, and healthcare professionals should refer to the dosing chart to determine the appropriate dosage based on the child's weight or age. Prior to administration, the product must be shaken well to ensure proper mixing.

For children weighing under 36 pounds or under 4 years of age, the use of this product is not recommended. For children weighing between 36 and 47 pounds, or aged 4 to 5 years, the recommended dose is 5 mL. For children weighing between 48 and 95 pounds, or aged 6 to 11 years, the recommended dose is 10 mL.

The dosing should be administered using the enclosed dosing cup specifically designed for this product; no other dosing devices should be utilized. The dose should be squeezed into the dosing cup after removing the child protective cap.

Dosing may be repeated every 4 hours as needed while symptoms persist, but it is critical not to exceed 5 doses within a 24-hour period. Healthcare professionals should ensure that caregivers are aware of the overdose warning and the importance of adhering to the recommended dosing guidelines.

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 children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. MAOIs are used for the treatment of depression, psychiatric or emotional conditions, and Parkinson's disease. If there is uncertainty about the child's prescription, a healthcare professional should be consulted.

• In individuals with a known allergy to this product or any of its ingredients, as this may lead to serious allergic reactions.

Additionally, this product should be kept out of reach of children, and the recommended dosage should not be exceeded to avoid potential overdose.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the maximum daily dosage is exceeded. Specifically, liver damage may occur if a child takes more than 5 doses within a 24-hour period or if it is used concurrently with other medications containing acetaminophen.

Allergy Alert Acetaminophen may lead to severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Sore Throat Warning If a child experiences a severe sore throat that persists for more than 2 days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is advised.

General Precautions Prior to administration, it is essential to consult a healthcare professional if the child has a history of liver disease, persistent or chronic cough (such as that associated with asthma), or cough accompanied by excessive phlegm (mucus). Additionally, consultation with a doctor or pharmacist is recommended if the child is currently taking the anticoagulant warfarin.

Emergency Medical Help Instructions In the event of an overdose, immediate medical attention is crucial. Contact a Poison Control Center at 1-800-222-1222 without delay, as rapid intervention is vital for both adults and children, even in the absence of noticeable signs or symptoms.

Stop Taking and Call Your Doctor Instructions Discontinue use and seek medical advice if any of the following occur: pain or cough worsens or persists beyond 5 days; fever worsens or lasts more than 3 days; new symptoms develop; 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 underlying condition that requires further evaluation.

Side Effects

Severe adverse reactions associated with this product include the potential for severe liver damage, particularly in patients who exceed the maximum daily dosage of five doses within a 24-hour period or who concurrently use other medications containing acetaminophen. Patients should be advised that acetaminophen may also lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of any skin reaction, it is imperative to discontinue use and seek immediate medical assistance.

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

This product should not be used in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. Additionally, it is contraindicated in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. Patients with a known allergy to this product or any of its ingredients should also refrain from use.

Before administering this product, it is advisable to consult a healthcare provider if the patient has liver disease, a persistent or chronic cough (such as that associated with asthma), or a cough accompanied by excessive phlegm. Furthermore, patients taking the anticoagulant warfarin should seek guidance from a healthcare professional prior to use.

While using this product, patients must adhere to the recommended dosage to avoid overdose. They should discontinue use and consult a doctor if 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 occurs, or if a cough recurs with a rash or headache lasting longer than expected. These symptoms may indicate a serious underlying condition.

In the event of an overdose, immediate medical attention is crucial. Patients should contact a Poison Control Center or seek medical help without delay, even if no signs or symptoms are apparent.

Drug Interactions

Acetaminophen may interact with warfarin, a blood-thinning medication. It is advisable for patients to consult a healthcare professional, such as a doctor or pharmacist, prior to using acetaminophen if they are concurrently taking warfarin. This interaction may necessitate closer monitoring of coagulation parameters to ensure patient safety.

Additionally, acetaminophen should not be used in conjunction with any other medications that contain acetaminophen. This precaution is essential to prevent the risk of overdose, which can lead to severe liver damage. Patients should be advised to carefully read labels and avoid combining products that contain acetaminophen.

Packaging & NDC

Below are the non-prescription pack sizes of Cvs Childrens (acetaminophen and dextromethorphan hydrobromide). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 4 years of age should not use this medication. For children aged 4 to 5 years, the recommended dosage is 5 mL, while for those aged 6 to 11 years, the recommended dosage is 10 mL. It is important not to exceed 5 doses within a 24-hour period. When determining the appropriate dose, weight should be used if possible; otherwise, age may be utilized.

Healthcare professionals should advise caregivers to keep the medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Prior to administration, it is essential to consult a doctor if the pediatric patient has liver disease, a persistent or chronic cough (such as that associated with asthma), or a cough accompanied by excessive phlegm. Additionally, consultation with a doctor or pharmacist is advised if the child is concurrently taking the anticoagulant warfarin.

Geriatric Use

Elderly patients may not have specific information regarding the use of this product, as the prescribing information does not provide guidance on geriatric use. The product is primarily indicated for children aged 4-11 years.

Given the absence of dosage adjustments or safety concerns mentioned for elderly patients, healthcare providers should exercise caution when considering this product for geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or unexpected responses, as individual patient factors may influence treatment outcomes.

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

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk. The effects of this product on a nursing infant are not well studied; therefore, caution is advised.

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 consult a healthcare professional prior to use, particularly if they have a history of liver disease. It is essential to assess liver function and consider potential adjustments in dosage or monitoring requirements based on the severity of the impairment. Close monitoring of liver function tests may be warranted to ensure safety and efficacy in this population.

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 intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the timely recognition and management of overdose situations can significantly impact patient outcomes. Therefore, it is essential to remain vigilant and proactive in addressing potential overdose cases.

Nonclinical Toxicology

No information is available regarding teratogenic effects. Additionally, there is no information provided concerning non-teratogenic effects. The insert does not contain any details related to nonclinical toxicology. Furthermore, there is no information available regarding animal pharmacology and toxicology.

Postmarketing Experience

No specific postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this product 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.

Patients should be cautioned against using this product in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. Healthcare providers should recommend that patients verify with a doctor or pharmacist if they are unsure whether their child's prescription includes an MAOI.

Patients must be informed not to use this product if their child has a history of allergic reactions to it or any of its ingredients. They should be instructed to stop use and seek medical advice if pain or cough worsens or persists beyond five days, if fever worsens or lasts more than three days, or if new symptoms arise. Additionally, patients should be advised to discontinue use and consult a doctor if any redness or swelling occurs, or if a cough returns or is accompanied by a rash or headache that lasts, as these may indicate a serious condition.

While using this product, patients should be reminded not to exceed the recommended dose, and they should be made aware of the overdose warning. Healthcare providers should also recommend that patients consult a doctor before use if their child has liver disease, persistent or chronic cough (such as that associated with asthma), or a cough that produces excessive phlegm. Lastly, patients should be advised to seek guidance from a doctor or pharmacist if their child is taking the blood-thinning medication warfarin.

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 room temperature to maintain its integrity and efficacy. No special handling requirements are noted; however, standard precautions should be observed to ensure optimal storage conditions.

Additional Clinical Information

The medication is administered orally, with a recommended repeat dose every 4 hours as needed for symptom relief, not to exceed 5 doses within a 24-hour period. Clinicians should advise patients to keep the medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, and patients are encouraged to contact a Poison Control Center at 1-800-222-1222, as prompt attention is crucial for both adults and children, regardless of the presence of symptoms.

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

Drug Information (PDF)

This file contains official product information for Cvs Childrens, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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