Meijer Childrens

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with the common cold, flu, headache, sore throat, and toothache. 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 use in specific populations, and healthcare professionals should refer to the dosage chart to determine the appropriate dose based on the patient's weight or age.

For patients weighing under 24 pounds or under 2 years of age, it is advised to consult a physician before administration. For those weighing between 24 to 35 pounds or aged 2 to 3 years, the recommended dose is 1 tablet. Patients weighing 36 to 47 pounds or aged 4 to 5 years should receive 1 ½ tablets. For individuals weighing 48 to 59 pounds or aged 6 to 8 years, the dosage is 2 tablets. Patients weighing 60 to 71 pounds or aged 9 to 10 years should be administered 2 ½ tablets, while those weighing 72 to 95 pounds or aged 11 years and older may take 3 tablets.

The product must be chewed completely before swallowing; it should not be swallowed whole. 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 patients do not exceed the recommended dosage 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, is prohibited 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.

Additionally, this product should not be used in patients with a known allergy to acetaminophen or any of the inactive ingredients contained in this formulation, as this may lead to severe allergic reactions.

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.

Acetaminophen may also trigger severe skin reactions. Symptoms indicative of such reactions include skin reddening, blistering, and rash. In the event of any skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare providers should be vigilant regarding the potential for severe sore throat symptoms. If a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a physician is recommended.

General precautions should be taken when administering this product. It is advisable to consult a physician prior to use if the child has a history of liver disease. Furthermore, caregivers should seek guidance from a doctor or pharmacist if the child is concurrently taking the anticoagulant warfarin.

In cases of suspected overdose, immediate medical attention is crucial. Caregivers should contact a Poison Control Center at 1-800-222-1222 without delay, even if no symptoms are apparent.

Healthcare professionals should instruct caregivers to discontinue use and consult a physician if any of the following occur: pain worsens or persists beyond five days, fever intensifies or lasts more than three days, new symptoms arise, or if redness or swelling is observed. These signs may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed five doses within a 24-hour period, which is the maximum daily amount, or if they use it concurrently with other medications containing acetaminophen. Patients should be aware of the potential for severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blistering, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Patients are advised to consult a healthcare professional if they experience a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting. The product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription, and patients should verify the presence of acetaminophen in other medications with a doctor or pharmacist if uncertain. Additionally, this product is contraindicated in patients with a known allergy to acetaminophen or any of the inactive ingredients.

Before using this product, patients with liver disease should seek medical advice. Furthermore, those taking the blood-thinning medication warfarin should consult a healthcare provider or pharmacist prior to use.

While using this product, it is crucial not to exceed the recommended dosage. Patients should discontinue use and consult a doctor if pain worsens or persists beyond five days, if fever intensifies or lasts more than three days, if new symptoms arise, or if redness or swelling occurs, as these may indicate a serious condition.

In the event of an overdose, immediate medical attention is necessary. Patients should contact a Poison Control Center or seek medical help right away, even if no signs or symptoms are apparent, as prompt intervention is critical.

Drug Interactions

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking warfarin, a blood-thinning agent. The combination may elevate the risk of bleeding due to potential pharmacodynamic interactions.

No additional drug interactions or laboratory test interactions have been identified for this medication. Therefore, routine monitoring or dosage adjustments are not specified beyond the aforementioned consideration with warfarin.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 2 to 11 years may use this medication according to the following dosing recommendations. For children under 2 years, consultation with a doctor is advised.

For children aged 2-3 years, the recommended dose is 1 tablet (160 mg). For ages 4-5 years, the dose increases to 1 ½ tablets (240 mg). Children aged 6-8 years should receive 2 tablets (320 mg), while those aged 9-10 years may take 2 ½ tablets (400 mg). At age 11 years, the recommended dose is 3 tablets (480 mg).

It is important to adhere to the dosage instructions, which specify not to exceed 5 doses in a 24-hour period and to repeat doses every 4 hours as needed while symptoms persist. Tablets should be chewed completely and not swallowed whole.

Healthcare professionals should be aware of the following warnings: severe liver damage may occur if more than 5 doses are taken within 24 hours. Consultation with a doctor is recommended if the child has liver disease or is taking warfarin. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center, as prompt medical attention is critical even if no symptoms are present.

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 indicated for use in children aged 2-11 years, and there are no documented dosage adjustments or safety concerns specifically related to elderly patients.

Healthcare providers should exercise caution when prescribing this product to geriatric patients, considering the lack of data on its safety and efficacy in this population. Monitoring for potential adverse effects is advisable, given the absence of established guidelines for use in individuals aged 65 and older.

Pregnancy

The available prescribing information does not provide specific data regarding the use of acetaminophen during pregnancy. Consequently, there are no established safety concerns, dosage modifications, or special precautions outlined for pregnant patients. Healthcare professionals should consider the lack of information when advising women of childbearing potential and weigh the potential benefits against any unknown risks associated with the use of acetaminophen during pregnancy. It is advisable to monitor emerging data and guidelines to inform clinical decision-making in this population.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or any lactation considerations. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. The effects on breastfed infants have not been established.

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 be closely monitored 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 five doses within a 24-hour period, as this represents the maximum daily amount. Additionally, patients should avoid concomitant use with other medications containing acetaminophen to prevent the risk of liver injury.

Before initiating treatment, it is advisable for patients with liver disease to consult a healthcare professional. This precaution is essential to ensure the safe use of the product and to evaluate the potential need for dosage adjustments or alternative therapies based on the severity of hepatic impairment. Regular assessment of liver function may be warranted in these patients to monitor for any adverse effects.

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, even in the absence of noticeable signs or symptoms. Healthcare professionals should be aware that early recognition and management of an overdose can significantly impact patient outcomes.

It is essential to monitor the patient closely for any potential symptoms that may arise following an overdose. The specific manifestations can vary depending on the substance involved and the amount ingested. Therefore, a thorough assessment and appropriate supportive care should be initiated as soon as possible.

In summary, the key actions in managing an overdose include rapid medical evaluation and intervention, as well as vigilant monitoring for any delayed symptoms that may develop.

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 compound in these areas.

Postmarketing Experience

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

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose, emphasizing that prompt medical attention is crucial even if no signs or symptoms are apparent.

Patients should be informed not to use this product in conjunction with any other medications that contain acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, patients are encouraged to consult with a doctor or pharmacist.

It is important to instruct patients not to use this product if their child has a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation.

Patients should be counseled to discontinue use and consult a doctor if pain worsens or persists for more than 5 days, if fever intensifies or lasts longer than 3 days, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious condition.

Healthcare providers should stress the importance of adhering to the recommended dosage and to be aware of the overdose warning associated with this product.

Additionally, patients should be advised to consult a doctor prior to use if their child has liver disease. It is also recommended that patients speak with a doctor or pharmacist before using this product if their child is currently taking the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for reference. It should be stored at room temperature, ensuring that it is kept away from high humidity and protected from light exposure. For optimal preservation, it is essential to check the end flap of the packaging for the expiration date and lot number.

Additional Clinical Information

The medication is administered orally, with a recommended repeat dose every 4 hours as long as 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 Meijer Childrens, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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