Walgreen Childrens

Description

No description information is available for the specified 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 effects associated with this drug, and no nonteratogenic effects have been reported.

Dosage and Administration

Shake the product well before use. Healthcare professionals should refer to the dosing chart below to determine the appropriate dose based on the child's weight or age. It is recommended to use weight for dosing whenever possible; if weight is not available, age may be used as a guide.

To administer the dose, remove the child protective cap and squeeze the appropriate amount into the enclosed dosing cup, which is specifically designed for use with this product. The dose may be repeated every 4 hours as needed, while symptoms persist. However, it is important not to exceed 5 doses within a 24-hour period.

Dosing Chart:

• For children weighing under 36 lb (under 4 years): Do not use.

• For children weighing 36-47 lb (4 to 5 years): Administer 5 mL.

• For children weighing 48-95 lb (6 to 11 years): Administer 10 mL.

It is crucial to adhere to the dosing recommendations and not exceed the directed amount to avoid the risk of overdose.

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 currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment, as this may lead to serious drug interactions. If there is uncertainty about the presence of an MAOI in a child's medication, a healthcare professional should be consulted prior to use.

• In individuals with a known history of allergic reactions to this product or any of its components, to prevent potential severe allergic responses.

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 5 doses should be administered within a 24-hour period. Additionally, caution is warranted when this product 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. Should any of these symptoms manifest, it is imperative to discontinue use immediately and seek medical assistance.

Sore Throat Warning In cases where a sore throat is severe, persists beyond 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is essential.

General Precautions Prior to administration, it is advisable to consult a physician 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. Furthermore, caregivers should seek guidance from a doctor or pharmacist if the child is concurrently taking the anticoagulant warfarin.

Emergency Medical Help In the event of an overdose, immediate medical attention is crucial. Caregivers should 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 symptoms.

Discontinuation of Use Healthcare professionals should instruct caregivers to stop the use of this product and consult a physician if any of the following occur: worsening pain or cough lasting more than 5 days; fever that worsens or persists beyond 3 days; the emergence of new symptoms; presence of redness or swelling; or recurrence of cough accompanied by rash or headache lasting longer than expected. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product.

Severe liver damage is a significant concern, 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.

Allergic reactions may also occur, with acetaminophen potentially causing severe skin reactions. Symptoms of such reactions can include skin reddening, blisters, and rash. In the event of a skin reaction, patients are advised to discontinue use immediately and seek medical assistance.

Patients should be vigilant for severe sore throat symptoms that persist for more than two days or are accompanied by fever, headache, rash, nausea, or vomiting, and should consult a healthcare provider promptly in these cases.

Additionally, patients are instructed to stop use and consult a doctor if any of the following occur: pain or cough worsens or lasts longer than five days; fever worsens or lasts longer than three days; new symptoms develop; redness or swelling is observed; or if a cough recurs or occurs alongside a rash or headache that persists. These symptoms may indicate a serious underlying condition that requires medical evaluation.

Drug Interactions

Concurrent use of this medication with any other drug containing acetaminophen is contraindicated due to the risk of severe liver damage.

In pediatric patients, it is advisable to consult a healthcare professional, such as a doctor or pharmacist, prior to administration if the child is concurrently taking the anticoagulant warfarin. Monitoring of coagulation parameters may be warranted to ensure safety and efficacy.

Packaging & NDC

Below are the non-prescription pack sizes of Walgreen 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 a Poison Control Center.

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, caregivers should seek advice from a doctor or pharmacist if the child is concurrently taking the anticoagulant warfarin.

Geriatric Use

There is no specific information regarding the use of this drug in geriatric patients. Therefore, healthcare providers should exercise caution when prescribing this medication to elderly patients. It is advisable to closely monitor this population for any potential adverse effects or changes in drug efficacy, as age-related physiological changes may influence drug metabolism and response. Additionally, consideration should be given to the presence of comorbidities and polypharmacy, which are common in geriatric patients and may necessitate dosage adjustments or increased vigilance in monitoring.

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 prior to use, as there may be potential risks to the fetus. Specific studies or data regarding fetal outcomes are not provided in the prescribing information. No specific dosage modifications for pregnant individuals are mentioned; however, it is strongly advised to seek medical advice before using this product during pregnancy.

Lactation

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

Renal Impairment

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function in the provided drug insert text. Healthcare professionals should exercise caution and consider individual patient factors when prescribing this medication to patients with renal impairment.

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 patient 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 lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, it is essential to monitor the patient closely and provide supportive care as needed.

Management of an overdose may involve symptomatic treatment and monitoring of vital signs, as well as specific interventions based on the substance involved. It is recommended that healthcare providers follow established protocols for overdose management to ensure optimal patient 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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions. Reports indicate that symptoms can include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

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 medication containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, patients 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 within two weeks of stopping such medication. If there is any doubt about whether a child's prescription includes an MAOI, it is essential to seek guidance from a healthcare professional.

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 discontinue use and consult a doctor if the child's pain or cough worsens or persists for more than five days, if fever worsens or lasts more than three days, or if new symptoms arise. Additionally, patients should be advised to seek medical attention 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.

While using this product, patients should be reminded not to exceed the recommended dose, and they should be made aware of the overdose warning. It is also advisable for patients to consult a doctor before use if their child has liver disease, a persistent or chronic cough such as that associated with asthma, or a cough that produces excessive phlegm (mucus). Furthermore, patients should be encouraged to speak with 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 assigned 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 while symptoms persist. Clinicians should ensure that patients do not exceed 5 doses within a 24-hour period. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)