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, minor arthritis pain, muscular aches, the common cold, backache, toothache, and menstrual cramps.

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

Dosage and Administration

Adults and children aged 12 years and older are instructed to open one pack of the medication and place the powder directly on the tongue every 6 hours, as long as symptoms persist. It is recommended to drink a full glass of water with each dose. Alternatively, the powder may be stirred into a glass of water or another suitable liquid prior to consumption.

The maximum dosage for adults and children over 12 years is limited to 4 packs within a 24-hour period, unless otherwise directed by a healthcare professional.

For children under 12 years of age, it is advised 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 other 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, a rare but serious illness. If any changes in behavior accompanied by nausea and vomiting occur while using this product, it is imperative to consult a healthcare professional immediately.

Allergy Alert Aspirin may induce severe allergic reactions, which can manifest as hives, facial swelling, shock, or asthma (wheezing). Additionally, acetaminophen has the potential to cause severe skin reactions, including skin reddening, blisters, or rash. Should any skin reaction occur, the use of the product must be discontinued, and medical assistance should be sought without delay.

Liver Warning This product contains acetaminophen, and severe liver damage may occur if the following conditions are met: exceeding 4 packs in a 24-hour period (the maximum daily amount), concurrent use with other medications containing acetaminophen, or consumption of three or more alcoholic drinks daily while using this product.

Stomach Bleeding Warning As this product contains a nonsteroidal anti-inflammatory drug (NSAID), there is a risk of severe stomach bleeding. The likelihood of this adverse effect is increased in individuals who are 60 years of age 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 while using this product, or take more than the recommended dosage or for an extended duration.

Caffeine Warning This product contains caffeine. 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.

Stop Use and Consult a Doctor Users should discontinue use and seek medical advice if an allergic reaction occurs or if any of the following signs of stomach bleeding are experienced: feeling faint, vomiting blood, having bloody or black stools, experiencing stomach pain that does not improve, having pain that worsens or lasts longer than 10 days, noticing a fever that worsens or lasts more than 3 days, observing redness or swelling, experiencing any new symptoms, or having ringing in the ears or loss of hearing. These symptoms may indicate a serious condition.

Emergency Medical Help In the event of an overdose, it is crucial to seek immediate medical assistance or contact the Poison Control Center at 1-800-222-1222. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

Side Effects

Patients using this product should be aware of several serious and common 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 may occur, particularly in patients sensitive to aspirin. Symptoms of such reactions can include hives, facial swelling, shock, and asthma (wheezing). Additionally, acetaminophen, another component of this product, may lead to severe skin reactions characterized by skin reddening, blisters, or rash. In the event of a skin reaction, patients should discontinue use and seek medical assistance promptly.

The product contains acetaminophen, which poses a risk of severe liver damage if patients exceed the maximum daily amount of 4 packs within 24 hours, use it in conjunction with other acetaminophen-containing medications, or consume three or more alcoholic drinks daily while using this product.

As this product contains a nonsteroidal anti-inflammatory drug (NSAID), there is a risk of severe stomach bleeding, particularly in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid medications, or are consuming three or more alcoholic drinks daily. Patients should also be cautious if they take other NSAIDs, whether prescription or over-the-counter, or if they exceed the recommended dosage or duration of use.

Caffeine is another component of this product, and excessive intake may lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat. Patients are advised to limit the use of other caffeine-containing medications, foods, or beverages.

Patients should stop using the product and seek medical attention if they experience any signs of an allergic reaction or symptoms indicative of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Other concerning symptoms include worsening fever lasting more than three days, redness or swelling, the appearance of new symptoms, or ringing in the ears or loss of hearing.

Before using this product, patients should consult a doctor 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.

Drug Interactions

There are currently no documented drug interactions associated with 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, 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 6 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 medication. It is essential for healthcare providers to exercise caution when prescribing to this population and to monitor for any signs of gastrointestinal bleeding.

Additionally, geriatric patients with pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease should consult with their healthcare provider prior to use. These conditions may necessitate dosage adjustments or additional monitoring to ensure the safety and efficacy of the treatment in elderly individuals.

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 developing fetus 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 pregnancy 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 the use of this medication 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. It is important to note that this product contains acetaminophen, which carries a risk of severe liver damage. Patients are advised to adhere strictly to the maximum daily dosage of 4 packs within a 24-hour period. Exceeding this limit, particularly in conjunction with other medications containing acetaminophen or the consumption of three or more alcoholic drinks daily, may significantly increase the risk of liver injury. Monitoring of liver function is recommended for patients with compromised liver function 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 the 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 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 details regarding nonclinical toxicology or animal pharmacology and toxicology provided in the text.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs.

Allergic reactions, including hives, facial swelling, shock, and asthma (wheezing), have been associated with aspirin. Severe skin reactions related to acetaminophen use have also been reported, manifesting as skin reddening, blisters, and rash. Additionally, there have been reports of severe liver damage linked to acetaminophen, particularly in instances of overdose or concurrent use with other acetaminophen-containing products.

Incidents of severe stomach bleeding associated with the use of nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin, have been noted, especially in patients over 60 years of age or those with a history of stomach ulcers or bleeding problems. Furthermore, cases of nervousness, irritability, sleeplessness, and rapid heart rate have been reported in relation to excessive caffeine intake.

Patient Counseling

Healthcare providers should advise patients about the serious risks associated with overdose. It is important to communicate that taking more than the recommended dose can lead to significant health complications. Patients should be informed that in the event of an overdose, they must seek medical assistance immediately or contact the Poison Control Center at 1-800-222-1222.

Emphasize the urgency of obtaining quick medical attention for both adults and children, even if they do not exhibit any noticeable signs or symptoms of overdose. This proactive approach can be critical in ensuring patient safety and effective management of potential overdose situations.

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 25°C (77°F) to maintain its integrity and efficacy. Proper storage conditions should be ensured to prevent exposure to higher temperatures, which may compromise 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)