Goodys

Description

No description information is available for the specified 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, the common cold, backaches, toothaches, muscular aches, and menstrual cramps.

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

Dosage and Administration

For adults and children aged 12 years and over, the recommended dosage is to open one pack and place the powder directly on the tongue every 6 hours, as needed, while 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 administration.

It is important not to exceed 4 packs within a 24-hour period unless specifically 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. 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 illness.

Aspirin, a component of this product, may lead to severe allergic reactions, which can manifest as hives, facial swelling, asthma (wheezing), or shock. Additionally, acetaminophen may cause severe skin reactions, including skin reddening, blisters, or rash. In the event of a skin reaction, it is crucial to discontinue use immediately and seek medical assistance.

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 (the maximum daily amount), concurrent use with other medications containing acetaminophen, or consumption of three or more alcoholic drinks daily while using this product.

The presence of an NSAID in this product raises the risk of severe stomach bleeding, particularly 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, 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. Excessive caffeine consumption may lead to symptoms such as 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 using this product.

In the event of an overdose, immediate medical attention is necessary. Patients should contact a Poison Control Center (1-800-222-1222) without delay, as prompt intervention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

Patients should discontinue use and contact a healthcare provider if they experience any signs of an allergic reaction or any of the following symptoms indicative of stomach bleeding: feeling faint, vomiting blood, having bloody or black stools, experiencing persistent stomach pain, or if pain worsens or lasts more than 10 days. Additionally, if fever worsens or lasts more than three days, redness or swelling occurs, new symptoms appear, or there is ringing in the ears or loss of hearing, medical consultation is warranted, as these may signify a serious condition.

Side Effects

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

Serious adverse reactions include the risk of Reye’s syndrome, particularly in children and teenagers who have or are recovering from chickenpox or flu-like symptoms. If patients exhibit changes in behavior accompanied by nausea and vomiting, they should consult a healthcare professional immediately, as these may be early signs of this rare but serious illness.

Allergic reactions to aspirin can occur and may manifest as hives, facial swelling, asthma (wheezing), or shock. Patients experiencing any signs of an allergic reaction should seek medical attention promptly. Additionally, acetaminophen has been associated with severe skin reactions, which may present as skin reddening, blisters, or rash. In the event of a skin reaction, patients are advised to discontinue use and seek immediate medical help.

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

Furthermore, the presence of an NSAID in this product raises concerns regarding stomach bleeding. The risk is heightened in patients aged 60 or older, those with a history of stomach ulcers or bleeding problems, individuals taking blood thinners or steroid medications, and those using other NSAIDs. Patients who consume three or more alcoholic drinks daily while using this product or take it for longer than directed are also at increased risk.

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

Patients should stop using the product and consult a healthcare professional 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. Additional symptoms warranting medical attention 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. These could signify a serious condition requiring prompt evaluation.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are necessary 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 over 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. The maximum recommended dosage is four packs in 24 hours unless directed otherwise by a doctor. For children under 12 years of age, it is advised to consult a doctor before use.

An overdose warning is in place, as taking more than the recommended dose can lead to serious health problems. In the event of an overdose, immediate medical help should be sought, or contact a Poison Control Center (1-800-222-1222) without delay. Prompt medical attention is critical for both adults and children, even if no signs or symptoms are initially apparent.

Geriatric Use

Elderly patients may be at an increased risk for severe stomach bleeding when using this product, as it contains a nonsteroidal anti-inflammatory drug (NSAID). The likelihood of experiencing such adverse effects is notably higher in individuals aged 60 years and older.

It is essential for geriatric patients to consult with a healthcare provider prior to using this product, particularly if they have pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. Close monitoring and appropriate dose adjustments may be necessary to ensure safety and efficacy in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. The use of aspirin during pregnancy, particularly at 20 weeks gestation or later, is associated with potential risks. Specifically, it may lead to adverse effects on fetal outcomes or complications during delivery. Therefore, it is crucial that pregnant patients only use aspirin under the guidance of a qualified healthcare provider if deemed necessary.

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 under certain conditions. Specifically, patients should be aware that exceeding the maximum daily amount of 4 packs within a 24-hour period may lead to significant hepatic injury.

Additionally, the concurrent use of other medications containing acetaminophen should be avoided, as this can further increase the risk of liver damage. Patients who consume three or more alcoholic drinks daily while using this product are also at heightened risk for severe liver complications.

Due to these considerations, careful monitoring of liver function is advised for patients with compromised liver health, and dosage adjustments may be necessary based on individual assessment by a healthcare provider.

Overdosage

In the event of an overdose, it is imperative to recognize that exceeding the recommended dosage can lead to significant health complications. Healthcare professionals are advised to take immediate action by seeking medical assistance or contacting a Poison Control Center at 1-800-222-1222.

Prompt medical intervention is crucial for both adults and children, even in the absence of observable signs or symptoms. It is essential to monitor the patient closely and provide supportive care as necessary while awaiting further medical guidance.

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 or additional nonclinical toxicology details are available in the provided data. Furthermore, there are no specific findings related to animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. Reports have included allergic reactions such as hives, facial swelling, asthma (wheezing), and shock linked to aspirin. Severe skin reactions have been noted with acetaminophen, characterized by skin reddening, blisters, and rash. Additionally, there is a risk of severe liver damage associated with excessive use of acetaminophen.

The use of nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin, may lead to severe stomach bleeding. An increased risk of adverse effects has been observed in individuals aged 60 or older, those with a history of stomach ulcers or bleeding problems, and patients taking anticoagulants or other NSAIDs. Symptoms indicative of serious conditions, such as stomach bleeding, may include feeling faint, vomiting blood, having bloody or black stools, and persistent stomach pain. Furthermore, the emergence of new symptoms or the worsening of existing symptoms may signal serious conditions that necessitate medical attention.

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 problems. In the event of an overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. It is crucial for both adults and children to receive prompt medical attention, even if no signs or symptoms are initially present.

Patients should be cautioned against using this medication if they have a history of allergic reactions to aspirin or any other pain reliever or fever reducer. Additionally, they must not use this medication in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult a doctor or pharmacist.

Healthcare providers should instruct patients to discontinue use and seek medical advice if they experience any signs of an allergic reaction. Immediate medical assistance should be sought if symptoms such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain occur. Patients should also be informed that worsening pain, fever lasting more than three days, the presence of redness or swelling, the emergence of new symptoms, or any ringing in the ears or loss of hearing could indicate a serious condition requiring medical evaluation.

Before initiating treatment, patients should be advised 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 encouraged to discuss their conditions with a healthcare provider before using this medication. Lastly, patients on prescription medications for diabetes, gout, or arthritis should consult a doctor or pharmacist before 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 temperatures below 25°C (77°F) 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 exposure to conditions that 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)