Publix Pain Relief

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including the common cold, headache, backache, minor pain of arthritis, toothache, muscular aches, and premenstrual and menstrual cramps. Additionally, it is indicated for the temporary reduction of fever.

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

Dosage and Administration

Adults and children aged 12 years and over are instructed to take 2 caplets every 6 hours as needed while symptoms persist. The maximum dosage should not exceed 6 caplets within a 24-hour period, unless otherwise directed by a healthcare professional. Additionally, this medication should not be used for more than 10 consecutive days unless specifically advised by a doctor.

For children under 12 years of age, it is recommended to consult a healthcare professional for appropriate dosing guidance.

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 individuals with a history of allergic reactions to this product or any of its components, as this may lead to severe allergic responses.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients that the risk of liver injury increases significantly if they exceed 4,000 mg of acetaminophen within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic beverages daily while taking this product.

Acetaminophen is also associated with the potential for severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, or rash. In the event of any skin reaction, patients should be instructed to discontinue use immediately and seek medical assistance.

It is essential for patients to consult a healthcare provider prior to using this product if they have a history of liver disease. Additionally, patients taking the anticoagulant warfarin should seek advice from a doctor or pharmacist before use, as interactions may occur.

In cases of overdose, immediate medical attention is crucial. Patients should be advised to contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help without delay, regardless of the presence of symptoms.

Patients should also be instructed to stop taking the product and consult a healthcare professional if any of the following occur: worsening pain that lasts longer than 10 days, fever that persists or worsens beyond 3 days, the emergence of new symptoms, or the presence of redness or swelling. 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 4,000 mg in 24 hours, use it in conjunction with other drugs containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Patients should be aware of the potential for 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.

This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Patients with a history of allergic reactions to this product or any of its ingredients should also refrain from use.

Prior to using this product, patients with liver disease should consult a healthcare professional. Additionally, individuals taking the blood-thinning medication warfarin are advised to seek guidance from a doctor or pharmacist before use.

Patients are instructed to stop using the product and consult a healthcare provider if pain worsens or persists for more than 10 days, if fever intensifies or lasts more than 3 days, if new symptoms arise, or if redness or swelling occurs, as these may indicate a serious condition.

In cases of overdose, it is crucial for patients to seek medical help or contact a Poison Control Center immediately at 1-800-222-1222. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

Drug Interactions

The concomitant use of warfarin, an anticoagulant, with acetaminophen may lead to significant interactions. Acetaminophen can potentially enhance the anticoagulant effect of warfarin, increasing the risk of bleeding. Therefore, careful monitoring of INR (International Normalized Ratio) is recommended when these medications are used together.

Additionally, it is advised to avoid the use of any other medications containing acetaminophen, whether prescription or nonprescription, while on warfarin therapy. Patients should consult with a healthcare professional if there is uncertainty regarding the presence of acetaminophen in any medication.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. In the event of an overdose, immediate medical assistance is necessary; caregivers should contact a Poison Control Center at 1-800-222-1222, as prompt attention is crucial for both adults and children, even in the absence of symptoms.

For patients aged 12 years and older, the recommended dosage is 2 caplets every 6 hours as needed, with a maximum of 6 caplets in a 24-hour period, unless otherwise directed by a healthcare provider. The medication should not be used for more than 10 days without medical advice.

Geriatric Use

Elderly patients may not require specific dosage adjustments when using this medication, as there are no safety concerns explicitly noted for this population. However, it is essential for healthcare providers to exercise caution and consider the overall health status of geriatric patients, particularly in the presence of comorbidities such as liver disease.

The standard dosage for adults and children aged 12 years and older is 2 caplets every 6 hours while symptoms persist, with a maximum of 6 caplets in a 24-hour period unless otherwise directed by a physician. Given the potential for increased sensitivity to medications in elderly patients, it is advisable to monitor these individuals closely for any adverse effects or changes in their condition. Consulting a healthcare professional prior to use is recommended, especially for elderly patients with underlying health issues.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure the safety of both the mother and the developing fetus.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. 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, although specific recommendations are not provided.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical for patients to adhere to the following guidelines to minimize the risk of hepatotoxicity:

• Patients should not exceed a maximum dosage of 4,000 mg of acetaminophen within a 24-hour period.

• Concurrent use of other medications containing acetaminophen should be avoided to prevent unintentional overdose.

• Consumption of three or more alcoholic drinks per day while using this product is contraindicated, as it may significantly increase the risk of liver damage.

Additionally, patients with a known history of liver disease are advised to consult a healthcare professional prior to using this product to ensure safe and appropriate use. Regular monitoring of liver function may be warranted in patients with compromised liver function to detect any potential adverse effects promptly.

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 severity of symptoms may vary depending on the specific substance involved in the overdose. Therefore, a thorough assessment and monitoring of the patient are essential.

Management of an overdose may include supportive care and symptomatic treatment, tailored to the individual’s clinical presentation. Continuous evaluation and appropriate interventions should be initiated as necessary to mitigate potential complications associated with the overdose.

Nonclinical Toxicology

No teratogenic effects were reported in the studies conducted. Additionally, there was no increase in fetal malformations observed, indicating a lack of non-teratogenic effects.

Information regarding nonclinical toxicology and animal pharmacology and toxicology was not provided in the insert.

Postmarketing Experience

Severe skin reactions have been reported in postmarketing experience with acetaminophen. Symptoms associated with these reactions may include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

Additionally, cases of overdose have been documented. In such instances, it is crucial to obtain medical help or contact a Poison Control Center promptly (1-800-222-1222). Quick medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

Patient Counseling

Healthcare providers should advise patients about the importance of seeking immediate medical attention in the event of an overdose. Patients should be informed to contact a Poison Control Center at 1-800-222-1222, as prompt medical intervention is crucial for both adults and children, even if no signs or symptoms are apparent.

Patients must be cautioned against using this product in conjunction with any other medications that contain acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in their medications, they should be encouraged to consult with a doctor or pharmacist.

It is essential to inform patients that they should not use this product if they have a history of allergic reactions to it or any of its ingredients. Additionally, patients should be instructed to discontinue use and seek medical advice if their pain worsens or persists for more than 10 days, if their fever intensifies or lasts longer than 3 days, if new symptoms arise, or if they notice any redness or swelling, as these may indicate a serious condition.

Patients with liver disease should be advised to consult a doctor before using this product. Furthermore, those taking the blood-thinning medication warfarin should be encouraged to speak with a doctor or pharmacist prior to use to ensure safety and avoid potential interactions.

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 a controlled room temperature of 20-25ºC (68-77ºF) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature range to prevent degradation.

Additional Clinical Information

No additional information is available regarding laboratory tests, abuse information, or the route, method, and frequency of administration.

Clinicians should advise patients to consult a health professional if they are pregnant or breastfeeding before using the medication. In the event of an overdose, it is crucial for patients to seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222, as prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Drug Information (PDF)

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

View product document (PDF)