Acetaminophen

Description

Healthy Living™ acetaminophen chewable tablets are formulated for children aged 2 to 11 years and are indicated for pain relief and fever reduction. Each chewable tablet contains 160 mg of acetaminophen, with a total of 48 tablets per package. The tablets are designed to be chewed or crushed completely before swallowing and are available in a bubble gum flavor. This product is aspirin-free and ibuprofen-free. It is important to note that this medication should not be used in conjunction with other medicines containing acetaminophen.

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 pediatric patients, and specific dosing instructions must be followed to ensure safety and efficacy. Healthcare professionals should refer to the dosage chart below to determine the appropriate dose based on the patient's weight and age.

Tablets must be chewed or crushed completely before swallowing; they should not be swallowed whole. Dosing may be repeated every 4 hours as needed while symptoms persist, but it is imperative not to exceed 5 doses within a 24-hour period.

Dosage Chart:

• For patients weighing under 24 lbs (under 2 years of age): Consult a doctor for the appropriate dose.

• For patients weighing 24 to 35 lbs (2 to 3 years of age): Administer 1 tablet.

• For patients weighing 36 to 47 lbs (4 to 5 years of age): Administer 1½ tablets.

• For patients weighing 48 to 59 lbs (6 to 8 years of age): Administer 2 tablets.

• For patients weighing 60 to 71 lbs (9 to 10 years of age): Administer 2½ tablets.

• For patients weighing 72 to 95 lbs (11 years of age): Administer 3 tablets.

Dosing should be adjusted as necessary based on the patient's specific needs and in accordance with a healthcare provider's recommendations.

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 patients with a known allergy to acetaminophen or any of the inactive ingredients in this product, as this may lead to severe allergic reactions.

Additionally, it is imperative to adhere to the recommended dosing guidelines to avoid the risk of overdose.

Warnings and Precautions

Severe liver damage may occur in pediatric patients taking this product, which contains acetaminophen, if they exceed the maximum daily dosage of 5 doses within a 24-hour period or if used concurrently with other medications containing acetaminophen. Healthcare professionals should advise caregivers to strictly adhere to dosing guidelines to mitigate the risk of hepatotoxicity.

Acetaminophen has been associated with severe skin reactions, which may manifest as skin reddening, blisters, or rash. In the event of any skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

In cases of severe sore throat that persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is recommended to rule out serious underlying conditions.

Healthcare professionals should instruct patients and caregivers not to use this product in conjunction with any other medications containing acetaminophen, whether prescription or over-the-counter. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a physician or pharmacist is advised. Additionally, this product should not be administered to individuals with a known allergy to acetaminophen or any of the inactive ingredients contained within the formulation.

In the event of an overdose, immediate medical attention is crucial. Caregivers should be advised to contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help without delay, as rapid intervention is essential for both adults and children, even in the absence of overt symptoms.

Patients should be instructed to discontinue use and consult a healthcare provider if pain worsens or persists beyond 5 days, if fever intensifies or lasts more than 3 days, if new symptoms arise, or if there is any redness or swelling. These signs may indicate a serious medical condition requiring further evaluation.

Side Effects

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

Severe liver damage may occur in patients who exceed the maximum daily dosage of acetaminophen, which is five doses within a 24-hour period, or who take this product in conjunction with other medications containing acetaminophen. Patients with pre-existing liver disease should consult a doctor prior to use.

There is also an allergy alert associated with acetaminophen, as it may lead to severe skin reactions. Symptoms of such reactions can include skin reddening, blisters, and rash. If any of these symptoms occur, patients are advised to discontinue use immediately and seek medical assistance.

In cases where a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients should consult a doctor promptly.

Patients should stop using the product and seek medical advice if pain worsens or lasts longer than five days, if fever worsens or persists for more than three days, if new symptoms arise, or if redness or swelling is observed, as these may indicate a serious condition.

Additionally, patients taking the blood-thinning medication warfarin should consult a doctor or pharmacist before using this product to avoid potential interactions.

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 increase the risk of bleeding due to potential pharmacodynamic interactions.

Additionally, this medication should not be used in conjunction with any other products containing acetaminophen, whether prescription or over-the-counter. The risk of acetaminophen overdose may be heightened, leading to serious hepatic complications. If there is uncertainty regarding the presence of acetaminophen in other medications, it is advisable to seek guidance from a healthcare provider.

Packaging & NDC

Below are the non-prescription pack sizes of Acetaminophen. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should not exceed the recommended dosage, as overdose can occur. Tablets must be chewed or crushed completely before swallowing; they should not be swallowed whole. Dosing should ideally be based on weight; if weight is not available, age can be used as a guide. The following dosing chart provides the appropriate tablet dosage based on weight and age:

• Under 24 lbs (Under 2 years): Consult a doctor.

• 24 to 35 lbs (2 to 3 years): 1 tablet.

• 36 to 47 lbs (4 to 5 years): 1½ tablets.

• 48 to 59 lbs (6 to 8 years): 2 tablets.

• 60 to 71 lbs (9 to 10 years): 2½ tablets.

• 72 to 95 lbs (11 years): 3 tablets.

Doses may be repeated every 4 hours while symptoms persist, but should not exceed 5 doses in a 24-hour period. It is essential to keep this medication out of reach of children. Quick medical attention is critical for both children and adults, even if no signs or symptoms of overdose are apparent.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

The available prescribing information does not provide specific data regarding the use of acetaminophen during pregnancy. Consequently, healthcare professionals should exercise caution when recommending this medication to pregnant patients. There are no documented safety concerns, dosage modifications, or special precautions outlined for the use of acetaminophen in this population. Given the lack of information, it is advisable for women of childbearing potential to consult with their healthcare provider before using acetaminophen during pregnancy to ensure that potential risks and benefits are adequately assessed.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk. The effects of acetaminophen on a nursing infant are not well studied; therefore, caution is advised. It is recommended to monitor the infant for any adverse effects if the mother is taking acetaminophen while breastfeeding.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, as it contains acetaminophen, which poses a risk of severe liver damage. It is critical to adhere to the maximum daily dosage of 5 doses within a 24-hour period. Exceeding this limit, particularly in patients with compromised liver function, may significantly increase the risk of hepatotoxicity.

Additionally, patients should be advised to avoid concomitant use of other medications containing acetaminophen to prevent cumulative dosing, which could further exacerbate the risk of liver injury. Regular assessment of liver function may be warranted in these patients to ensure safety and efficacy while using this product.

Overdosage

In cases of overdosage, it is critical to recognize the potential for severe liver damage, particularly in pediatric patients.

Maximum Daily Dose Healthcare professionals should be aware that if a child ingests more than five doses of this product within a 24-hour period, there is a significant risk of severe liver damage. The maximum recommended daily amount must not be exceeded to prevent adverse effects.

Co-Administration with Acetaminophen Additionally, caution is advised when this product is administered concurrently with other medications containing acetaminophen. The combination can exacerbate the risk of severe liver damage, necessitating careful evaluation of all medications the patient may be taking.

Recommended Actions In the event of suspected overdosage, immediate medical attention is warranted. Healthcare providers should assess the patient's condition and consider appropriate management strategies, which may include monitoring liver function and providing supportive care as needed.

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 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 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. It is important to emphasize that quick medical attention is critical for both adults and children, even if no signs or symptoms are initially 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.

For pediatric patients, healthcare providers should caution against use if the child has a known allergy to acetaminophen or any of the inactive ingredients in the product. Additionally, patients should be instructed to 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 there is any redness or swelling, as these may indicate a serious condition.

It is essential to remind patients to adhere strictly to the recommended dosage to avoid the risk of overdose. Healthcare providers should also recommend that patients consult a doctor before use if their child has liver disease or is currently taking the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers, which should be referenced for identification. It is essential to store the product at a temperature range of 20° to 25°C (68° to 77°F). Care should be taken to avoid exposure to high humidity and to protect the product from light to maintain its integrity.

Healthcare professionals should ensure that the carton remains unopened and that the printed seal on the blister is intact. If the carton is open or the seal is broken or missing, the product should not be used.

Additional Clinical Information

The medication is administered orally, with specific instructions for patients to chew or crush the tablets completely before swallowing; whole tablets should not be swallowed. Dosing may be repeated every 4 hours as needed, but should not exceed 5 doses within a 24-hour period.

Clinicians should counsel patients to keep the medication out of reach of children. In the event of an overdose, it is crucial to seek medical assistance or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, regardless of the presence of symptoms.

Drug Information (PDF)

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

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