Pain Relief

Description

Acetaminophen 160 mg chewable tablets are formulated for oral administration and are presented in a bubble gum flavor. Each bottle contains 24 chewable tablets, which are designed to be chewed or crushed completely before swallowing. The formulation does not contain aspirin or ibuprofen. The product features a tamper-evident safety seal; it should not be used if the seal under the cap is broken or missing.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with headache, sore throat, flu, toothache, and the common cold. 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 does not contain directions or complete warnings for adult use. Healthcare professionals should ensure that the dosage administered does not exceed the recommended limits.

Dosing should be determined based on the patient's weight whenever possible; if weight is not available, age may be used as a guide. The following dosage chart provides the appropriate dosing for chewable tablets:

• For patients weighing under 24 lb or under 2 years of age, consultation with a doctor is advised.

• For patients weighing 24-35 lb (2-3 years), the recommended dose is 1 tablet.

• For patients weighing 36-47 lb (4-5 years), the recommended dose is 1 ½ tablets.

• For patients weighing 48-59 lb (6-8 years), the recommended dose is 2 tablets.

• For patients weighing 60-71 lb (9-10 years), the recommended dose is 2 ½ tablets.

• For patients weighing 72-95 lb (11 years), the recommended dose is 3 tablets.

Tablets should be chewed or crushed completely before swallowing; they must not be swallowed whole. Dosing may be repeated every 4 hours while symptoms persist, but should not exceed 5 doses in a 24-hour period. Additionally, this product should not be administered for more than 5 consecutive days unless directed by a healthcare professional.

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.

• This product should not be used in patients with a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation.

• Exceeding the recommended dosage while using this product is contraindicated, as it may lead to serious adverse effects.

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 if the 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. In the event of any skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare providers should be vigilant regarding 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.

Before administering this product, it is advisable to consult a physician 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 warfarin, a blood-thinning medication, to avoid potential interactions.

In cases of overdose, immediate medical attention is crucial. Caregivers should contact a Poison Control Center or seek emergency medical help without delay, as prompt intervention is essential for both adults and children, even in the absence of noticeable symptoms.

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 develop, or if redness or swelling is observed. These signs 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 the product is taken concurrently with other medications containing acetaminophen. Patients should also be alerted to the risk of severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Additionally, if a patient experiences a severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, they should consult a healthcare professional promptly.

This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Patients should verify the presence of acetaminophen in other medications with a doctor or pharmacist if uncertain. It is also contraindicated in patients with a known allergy to acetaminophen or any inactive ingredients in the formulation.

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

While using this product, patients must adhere to the recommended dosage and should discontinue use and consult a healthcare professional if pain worsens or persists beyond 5 days, if fever worsens or lasts more than 3 days, if new symptoms arise, or if redness or swelling occurs, as these may indicate a serious condition.

It is crucial to keep this product out of reach of children. In the event of an overdose, immediate medical attention should be sought, or contact with a Poison Control Center is advised, as prompt intervention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

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 Pain Relief (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 2 to 11 years may use this product according to the following dosing guidelines based on weight and age:

• For children under 24 lb (under 2 years), consultation with a doctor is advised.

• For those weighing 24-35 lb (ages 2-3 years), the recommended dose is 1 tablet.

• For children weighing 36-47 lb (ages 4-5 years), the dose is 1 1/2 tablets.

• For those weighing 48-59 lb (ages 6-8 years), the dose is 2 tablets.

• For children weighing 60-71 lb (ages 9-10 years), the dose is 2 1/2 tablets.

• For an 11-year-old weighing 72-95 lb, the dose is 3 tablets.

The maximum dosage should not exceed 5 doses in a 24-hour period, and the product should not be administered for more than 5 days unless directed by a healthcare professional.

Healthcare providers should be aware of the following warnings:

• Severe liver damage may occur if the maximum daily amount is exceeded or if the product is taken with other medications containing acetaminophen.

• Acetaminophen may cause severe skin reactions, including symptoms such as skin reddening, blisters, and rash. If any skin reaction occurs, use should be discontinued immediately, and medical assistance should be sought.

• If a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, a doctor should be consulted promptly.

Prior to use, consultation with a healthcare provider is recommended if the child has liver disease or is taking the anticoagulant warfarin. In the event of an overdose, immediate medical help or contact with a Poison Control Center is essential, as prompt medical attention is critical for both pediatric and adult patients.

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

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 acetaminophen to pregnant patients. The absence of safety concerns, dosage modifications, or special precautions in the labeling indicates a lack of comprehensive clinical or animal study data to inform risk assessment. Therefore, it is advisable for healthcare providers to weigh the potential benefits against any unknown risks when considering acetaminophen for women of childbearing potential.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there are no statements concerning the potential for excretion in breast milk or any associated risks to breastfed infants during the use of this product.

Renal Impairment

Patients with renal impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring, or safety considerations for individuals with reduced kidney function. Healthcare professionals should exercise caution when prescribing this medication to patients with renal impairment, as the lack of data necessitates careful consideration of potential risks and benefits.

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 dosage adjustments 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 without delay. Prompt medical intervention is crucial for both adults and children, regardless of whether any signs or symptoms are initially apparent.

Healthcare professionals should be aware that the absence of symptoms does not preclude the possibility of serious complications. Therefore, it is essential to monitor the patient closely and provide appropriate 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 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, 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 in the event of an overdose, as prompt medical attention is crucial for both adults and children, 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 any other medication, patients are encouraged to consult with a doctor or pharmacist.

It is essential to communicate that this product should not be used if the child has a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation.

Patients should be instructed 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.

While using this product, patients must be cautioned against exceeding the recommended dosage. Additionally, healthcare providers should advise patients to 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 configurations that include specific NDC numbers, which can be found on the packaging. It should be stored at a controlled room temperature of 25°C (77°F), with permissible excursions between 15°-30°C (59°-86°F). Care should be taken to avoid exposure to high humidity, as this may affect the product's integrity. For additional information regarding the expiration date and lot number, please refer to the end flap of the packaging.

Additional Clinical Information

Patients should be advised that the medication is administered orally, with tablets needing to be chewed or crushed completely before swallowing. Dosing can be repeated every 4 hours as long as symptoms persist, but should not exceed 5 doses within a 24-hour period. Additionally, the medication should not be used for more than 5 consecutive days unless directed by a healthcare professional.

Clinicians should counsel patients to keep the medication out of reach of children and to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is important to emphasize that prompt medical attention is crucial for both adults and children, even if no signs or symptoms of overdose are apparent.

Drug Information (PDF)

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

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