Goodys Pm Pain Reliever

Description

Goody’s EXTRA STRENGTH is a combination analgesic formulation containing acetaminophen, aspirin (a nonsteroidal anti-inflammatory drug), and caffeine. This product is designed to provide effective relief from pain. Each package contains 100 caplets, suitable for oral administration. The formulation leverages the synergistic effects of its active ingredients to enhance pain relief efficacy.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with headache, minor arthritis pain, muscle aches, and colds.

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage and administration guidelines to ensure safety and efficacy.

For adults and children aged 12 years and older, the recommended dosage is 2 caplets every 6 hours, with a maximum of 8 caplets within a 24-hour period. It is essential that each dose is accompanied by a full glass of water to facilitate proper absorption.

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

Patients are cautioned not to exceed the directed dosage, as an overdose may lead to serious health risks.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to aspirin or any other pain reliever or fever reducer. Additionally, concurrent use with any other medication containing acetaminophen, whether prescription or non-prescription, is contraindicated. If there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare professional is advised.

Warnings and Precautions

Children and teenagers who are experiencing or recovering from chickenpox or flu-like symptoms should not use this product due to the risk of Reye’s syndrome. If any changes in behavior accompanied by nausea and vomiting occur while using this product, it is imperative to consult a healthcare professional, as these symptoms may indicate the onset of this rare but serious condition.

Aspirin, a component of this product, may provoke severe allergic reactions. Symptoms of such reactions can include hives, facial swelling, shock, and asthma (wheezing). Immediate medical attention should be sought if an allergic reaction occurs.

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 8 caplets within a 24-hour period (the maximum daily dosage), concurrent use with other medications containing acetaminophen, or consumption of three or more alcoholic drinks daily while using this product.

The presence of a nonsteroidal anti-inflammatory drug (NSAID) in this formulation raises the potential for severe stomach bleeding. The risk is heightened in individuals who are 60 years of age or older, have a history of stomach ulcers or bleeding disorders, are taking anticoagulants or steroid medications, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic drinks daily, or exceed the recommended dosage or duration of use.

Caution is advised regarding caffeine intake, as the recommended dose of this product contains approximately the same amount of caffeine as a standard cup of coffee. Patients should limit the use of other caffeine-containing medications, foods, or beverages to avoid potential side effects such as nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Before using this product, individuals should consult a healthcare provider if they have liver disease, if the stomach bleeding warning applies, if they have a history of stomach issues (such as heartburn), or if they have conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. Additionally, those taking diuretics or who have asthma should seek medical advice prior to use.

Patients should discontinue use and contact a healthcare professional if they experience any signs of stomach bleeding, which may include feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Other concerning symptoms warranting medical attention include ringing in the ears or loss of hearing, redness or swelling in a painful area, worsening pain lasting more than 10 days, fever that worsens or persists for more than three days, or the emergence of any new symptoms.

Side Effects

Patients using this product may experience a range of adverse reactions, some of which may be serious.

Serious Adverse Reactions Reye’s syndrome is a rare but serious illness that can occur in children and teenagers who have or are recovering from chickenpox or flu-like symptoms. Patients should be advised not to use this product under these circumstances. If changes in behavior accompanied by nausea and vomiting occur, it is essential to consult a doctor, as these may be early signs of Reye’s syndrome.

Severe allergic reactions to aspirin may manifest as hives, facial swelling, shock, or asthma (wheezing). Patients experiencing any signs of an allergic reaction should seek medical help immediately.

This product contains acetaminophen, and severe liver damage may occur if patients exceed the maximum daily dosage of 8 caplets in 24 hours, use it in conjunction with other acetaminophen-containing drugs, or consume 3 or more alcoholic drinks daily while using this product.

Additionally, the presence of an NSAID in this formulation may lead to severe stomach bleeding, particularly in patients who are 60 years or older, have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid drugs, or are consuming alcohol excessively.

Common Adverse Reactions Patients should be advised to stop using the product and consult a doctor if they experience any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Other symptoms warranting medical consultation include ringing in the ears or loss of hearing, redness or swelling in a painful area, worsening pain lasting more than 10 days, fever lasting more than 3 days, or the appearance of any new symptoms.

Additional Considerations Patients are encouraged to consult a doctor before using this product if they have liver disease, a history of stomach problems such as heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, or if they are taking diuretics or have asthma.

Furthermore, the recommended dose of this product contains approximately the same amount of caffeine as a cup of coffee. Patients should limit the use of other caffeine-containing medications, foods, or beverages to avoid potential side effects such as nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat.

Drug Interactions

The concomitant use of this product with anticoagulants or steroid medications may elevate the risk of gastrointestinal bleeding. Healthcare professionals should exercise caution and consider monitoring patients for signs of bleeding when these medications are used together.

Additionally, the use of this product alongside other non-steroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin, ibuprofen, and naproxen, may further increase the risk of stomach bleeding. It is advisable for patients to consult a healthcare provider prior to using this product if they are currently taking any NSAID.

Furthermore, individuals prescribed medications for diabetes, gout, or arthritis should seek medical advice before using this product, as potential interactions may necessitate dosage adjustments or increased monitoring.

No specific interactions with laboratory tests have been identified in the available data.

Packaging & NDC

Below are the non-prescription pack sizes of Goodys Pm Pain Reliever (acetaminophen and aspirin and caffeine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product due to the risk of Reye’s syndrome, a rare but serious illness. If changes in behavior accompanied by nausea and vomiting occur while using this product, it is important to consult a doctor, as these symptoms may indicate the onset of Reye’s syndrome.

For dosing, adults and children aged 12 years and older are directed to take 2 caplets every 6 hours, with a maximum of 8 caplets in a 24-hour period. For children under 12 years of age, it is advised to consult a doctor before use.

Geriatric Use

Elderly patients, particularly those aged 60 and older, may have an increased risk of stomach bleeding when using this medication. It is essential for healthcare providers to exercise caution when prescribing to this population, as the likelihood of adverse effects may be heightened.

Before initiating treatment, it is advisable for geriatric patients to consult with their healthcare provider if they have a history of high blood pressure, heart disease, liver cirrhosis, or kidney disease. These conditions may necessitate careful monitoring and potential dosage adjustments to ensure safety and efficacy in this vulnerable age group.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. The use of aspirin during the last trimester of pregnancy is particularly cautioned against, as it may lead to adverse effects on fetal outcomes or complications during delivery. Therefore, it is essential that pregnant patients only use aspirin in this period if explicitly directed by a healthcare provider.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. It is particularly important to avoid the use of aspirin during the last three months of pregnancy unless explicitly directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery. 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 considering the use of this medication while breastfeeding.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have a history of high blood pressure, heart disease, liver cirrhosis, or kidney disease. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the severity of renal impairment.

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 that patients do not exceed the maximum daily dosage of 8 caplets within a 24-hour period. Additionally, patients must avoid concurrent use with other medications containing acetaminophen and limit alcohol consumption to fewer than 3 drinks per day while using this product.

Before initiating treatment, patients with known liver disease, high blood pressure, heart disease, liver cirrhosis, or kidney disease should consult a healthcare professional. Monitoring of liver function may be warranted in these patients to ensure safety and efficacy during treatment.

Overdosage

Taking more than the recommended dose of this medication can lead to serious health complications. It is imperative that healthcare professionals remain vigilant regarding the potential risks associated with overdosage.

In the event of an overdose, immediate medical assistance should be sought. Healthcare providers are advised to contact a Poison Control Center at 1-800-222-1222 for guidance. Prompt intervention is crucial, as the onset of symptoms may not be immediately apparent.

Quick medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms. This proactive approach can significantly mitigate the risks associated with overdosage and improve patient outcomes.

Nonclinical Toxicology

It is especially important not to use aspirin during the last three months of pregnancy unless specifically directed by a healthcare professional, as it may lead to complications for the unborn child or during delivery. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no details regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. Patients must be informed not to use this medication if they have ever experienced an allergic reaction to aspirin or any other pain reliever or fever reducer.

It is essential to instruct patients not to use this medication in conjunction with any other drug containing acetaminophen, whether prescription or non-prescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult a doctor or pharmacist for clarification.

Patients should be advised to seek medical advice before using this medication if they have liver disease or if they have a history of stomach problems, such as heartburn. Additionally, those with high blood pressure, heart disease, liver cirrhosis, or kidney disease should also consult a doctor prior to use.

Healthcare providers should emphasize the importance of consulting a doctor before use if patients are taking a diuretic, have high blood pressure, or have asthma. Furthermore, patients should be encouraged to speak with a doctor or pharmacist if they are taking any other drug containing a nonsteroidal anti-inflammatory drug (NSAID), a blood-thinning (anticoagulant) or steroid medication, or a prescription drug for diabetes, gout, or arthritis.

Lastly, patients should be reminded to inform their healthcare provider about any other medications they are taking or if they are under a doctor’s care for any serious condition before using this medication.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It is essential to store the product at a controlled temperature range of 68ºF to 77ºF (20ºC to 25ºC) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept in a suitable container that protects it from environmental factors. Special handling requirements should be followed to prevent any compromise to the product's quality.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is 2 caplets every 6 hours, with a maximum of 8 caplets in a 24-hour period. For children under 12 years of age, it is advised to consult a doctor for appropriate dosing.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. It is particularly important to avoid the use of aspirin during the last trimester of pregnancy unless specifically directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery.

Drug Information (PDF)

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

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