Goodys

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 various conditions, including headache, backache, toothache, menstrual cramps, muscular aches, the common cold, and minor arthritis pain.

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 open one pack and place the powder directly on the tongue every six hours, as long as symptoms persist. Each dose should be accompanied by a full glass of water. Alternatively, the powder may be stirred into a glass of water or another suitable liquid prior to consumption.

It is imperative that no more than four packs are taken within a 24-hour period unless specifically directed by a healthcare professional.

For children under 12 years of age, it is recommended to consult a doctor before administration.

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 medication containing acetaminophen, whether prescription or nonprescription, 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 lead to severe allergic reactions, which can manifest as hives, facial swelling, shock, or asthma symptoms such as wheezing. Additionally, acetaminophen may cause severe skin reactions, including skin reddening, blisters, or rash. Should any skin reaction occur, the use of the product must be discontinued immediately, and medical assistance should be sought.

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 4 packs within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of three or more alcoholic drinks daily while using this product.

Furthermore, the presence of an NSAID in this product raises the risk of severe stomach bleeding, particularly in individuals who are 60 years or older, have a history of stomach ulcers or bleeding problems, 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.

Caffeine is also included in this product; therefore, it is advisable to limit the intake of other caffeine-containing medications, foods, or beverages, as excessive caffeine consumption may lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Healthcare professionals should advise patients to consult a doctor prior to use 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 high blood pressure, heart disease, liver cirrhosis, or kidney disease. Patients taking diuretics or those with asthma should also seek medical advice before use. Additionally, it is recommended that patients consult a doctor or pharmacist if they are currently taking prescription medications for diabetes, gout, or arthritis.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are initially apparent.

Patients should discontinue use and contact a healthcare provider if they experience any allergic reactions, signs of stomach bleeding (such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain), worsening pain lasting more than 10 days, a fever that worsens or lasts more than 3 days, any redness or swelling, the appearance of new symptoms, or symptoms such as ringing in the ears or loss of hearing.

Side Effects

Patients using this product should be aware of several serious adverse reactions associated with its use. Reye’s syndrome is a rare but serious illness that may occur in children and teenagers who have or are recovering from chickenpox or flu-like symptoms. If patients experience changes in behavior accompanied by nausea and vomiting while using this product, they should consult a doctor immediately, as these symptoms could indicate the onset of Reye’s syndrome.

Severe allergic reactions to aspirin may occur, presenting as hives, facial swelling, shock, or asthma (wheezing). Patients experiencing any signs of an allergic reaction should seek medical attention promptly. Additionally, acetaminophen, a component of this product, may lead to severe skin reactions, including skin reddening, blisters, or rash. If any skin reaction occurs, patients are advised to discontinue use and seek medical help immediately.

The product carries a liver warning due to the presence of acetaminophen. Severe liver damage may occur if patients exceed the maximum daily amount of 4 packs in 24 hours, use it in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Stomach bleeding is another serious risk associated with this product, as it contains a nonsteroidal anti-inflammatory drug (NSAID). The risk of severe stomach bleeding is heightened in patients who are 60 years or older, have a history of stomach ulcers or bleeding problems, take blood-thinning medications or steroids, use other NSAIDs, or consume three or more alcoholic drinks daily while using this product. Patients should be vigilant for signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain, and should seek medical attention if these symptoms occur.

Patients should also be cautious regarding caffeine intake, as this product contains caffeine. Excessive caffeine consumption may lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Patients are advised to stop using the product and consult a doctor if they experience any of the following: an allergic reaction, worsening pain lasting more than 10 days, fever lasting more than 3 days, redness or swelling, new symptoms, or symptoms such as ringing in the ears or loss of hearing, as these may indicate a serious condition.

Drug Interactions

There are currently no documented drug interactions associated with the use of this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Goodys (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 may be early signs of Reye’s syndrome.

For dosing, adults and children aged 12 years and older are instructed to open one pack and place the powder on the tongue every six hours while symptoms persist, ensuring to drink a full glass of water with each dose or stir the powder into a glass of water or other liquid. 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 severe stomach bleeding when using this product, which contains a nonsteroidal anti-inflammatory drug (NSAID). Therefore, caution is advised when prescribing this medication to geriatric patients.

It is essential for healthcare providers to assess the overall health status of elderly patients prior to initiating treatment. Patients with a history of high blood pressure, heart disease, liver cirrhosis, or kidney disease should consult with their healthcare provider before using this product. Monitoring for potential adverse effects is recommended to ensure patient safety and to make any necessary dosage adjustments.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. It is particularly important to avoid the use of aspirin after 20 weeks of pregnancy unless specifically directed by a physician, as it may pose risks to the unborn child and lead to complications during delivery. Healthcare providers should carefully evaluate the potential benefits and risks when considering the use of this medication in pregnant patients.

Lactation

Lactating mothers are advised to consult a health professional before using this medication. It is particularly important to avoid the use of aspirin at 20 weeks of gestation or later unless specifically 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 its use during lactation.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have conditions such as 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 consult a healthcare professional prior to using this product, particularly if they have a history of liver disease. It is important to note that this product contains acetaminophen, which carries a risk of severe liver damage.

To minimize the risk of hepatotoxicity, patients must adhere to the maximum daily dosage of 4 packs within a 24-hour period. Exceeding this limit, especially in conjunction with other medications containing acetaminophen or the consumption of three or more alcoholic drinks daily, may significantly increase the risk of severe liver damage.

Monitoring of liver function is advised for patients with compromised liver function who are using this product, to ensure safety and prevent potential adverse effects.

Overdosage

Taking more than the recommended dose of the medication can lead to serious health complications. 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 based on the amount ingested and the individual’s health status. Therefore, it is essential to monitor the patient closely and provide supportive care as needed. Early recognition and management of overdose symptoms can significantly improve outcomes.

Nonclinical Toxicology

It is especially important not to use aspirin at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor, as it may cause problems in the unborn child or complications during delivery. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no specific details regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has revealed reports of severe allergic reactions associated with aspirin, including hives, facial swelling, shock, and asthma (wheezing). Additionally, acetaminophen has been associated with severe skin reactions, characterized by symptoms such as skin reddening, blisters, and rash. There have also been reports of severe liver damage linked to acetaminophen use, particularly when the maximum daily dosage is exceeded or when used in conjunction with alcohol consumption.

Furthermore, postmarketing data indicate an increased risk of severe stomach bleeding in patients aged 60 years or older, those with a history of stomach ulcers or bleeding problems, or individuals taking other NSAIDs or anticoagulants. Reports have also suggested that excessive caffeine intake may result in symptoms such as nervousness, irritability, sleeplessness, and, in some cases, rapid heart rate.

Patient Counseling

Healthcare providers should advise patients about the potential risks associated with overdose, emphasizing that taking more than the recommended dose can lead to serious health issues. In the event of an overdose, patients should seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is crucial for both adults and children, even if no symptoms are apparent.

Patients should be informed not to use this medication if they have a history of allergic reactions to aspirin or any other pain reliever or fever reducer. It is also important to instruct patients to avoid using this medication in conjunction with any other products containing acetaminophen, whether prescription or nonprescription. If patients are uncertain about the contents of a medication, they should be encouraged to consult with a doctor or pharmacist.

Patients should be advised to discontinue use and seek medical advice if they experience any signs of an allergic reaction or if they notice symptoms indicative of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additionally, they should be instructed to stop use and consult a doctor if their pain worsens or persists beyond 10 days, if their fever intensifies or lasts more than 3 days, if there is any redness or swelling, or if new symptoms arise. Patients should also be made aware that they should seek medical attention if they experience ringing in the ears or a loss of hearing.

Before initiating treatment, patients should be encouraged to consult a doctor if they have liver disease, a history of stomach problems such as heartburn, or if the warning for stomach bleeding applies to them. Furthermore, patients with high blood pressure, heart disease, liver cirrhosis, or kidney disease should also seek medical advice prior to use. Those taking diuretics or who have asthma should be advised to consult a doctor before using this medication. Lastly, patients on prescription medications for diabetes, gout, or arthritis should be encouraged to discuss their current medications with a doctor or pharmacist before use.

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 temperatures below 25ºC (77ºF) 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 observed to prevent any compromise to the product's quality.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)