Goodys Extra Strength

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, muscle aches, the common cold, menstrual cramps, and toothache.

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 six hours, as needed, while 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 for administration.

Patients should not exceed four packs within a 24-hour period unless directed by a healthcare professional. For children under 12 years of age, consultation with a doctor is advised prior to use. It is essential to adhere to the recommended dosage to avoid the risk of overdose.

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, 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 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 crucial. Patients should contact a healthcare provider or the Poison Control Center at 1-800-222-1222 without delay, as prompt intervention is essential for both adults and children, even in the absence of noticeable symptoms.

Patients must discontinue use and contact a healthcare professional if they experience any signs of an allergic reaction, symptoms indicative 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 persists beyond three days, any redness or swelling, the emergence of new symptoms, or symptoms such as ringing in the ears or hearing loss, which may signal 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:

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. Patients should be advised to discontinue use and consult a doctor if they notice changes in behavior accompanied by nausea and vomiting, as these may be early signs of Reye’s syndrome.

Severe allergic reactions to aspirin can manifest as hives, facial swelling, shock, or asthma (wheezing). Patients experiencing any signs of an allergic reaction should seek immediate medical attention. Additionally, acetaminophen may lead to severe skin reactions, including skin reddening, blisters, or rash. If any skin reaction occurs, patients should stop using the product and seek medical help promptly.

The product contains acetaminophen, which poses a risk of severe liver damage if patients exceed the maximum daily amount of 4 packs in 24 hours, use it in conjunction with other acetaminophen-containing drugs, or consume 3 or more alcoholic drinks daily while using the product.

The presence of an NSAID in this product raises the risk of severe stomach bleeding, particularly in patients who are 60 years or older, have a history of stomach ulcers or bleeding problems, take anticoagulants or steroid drugs, use other NSAIDs, or consume alcohol excessively.

Common Adverse Reactions:

Patients should be cautious about caffeine intake, as excessive consumption may lead to nervousness, irritability, sleeplessness, and occasionally rapid heartbeat.

Patients are advised to stop using the product and consult a doctor if they experience any signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additionally, if pain worsens or lasts more than 10 days, fever intensifies or lasts more than 3 days, redness or swelling occurs, new symptoms appear, or if there is ringing in the ears or loss of hearing, medical advice should be sought.

Precautions:

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 Extra Strength (acetaminophen, aspirin, and caffeine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Children and teenagers who have or are 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 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 directed 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 dosage should not exceed four packs in 24 hours unless directed by a doctor. For children under 12 years of age, consultation with a doctor is advised before use.

Geriatric Use

Elderly patients, particularly those aged 60 years and older, are at an increased risk of severe stomach bleeding when using this product, which contains a nonsteroidal anti-inflammatory drug (NSAID). This risk is further heightened in individuals with a history of stomach ulcers or bleeding problems, those who are concurrently using blood-thinning medications (anticoagulants) or steroid drugs, and patients taking other NSAIDs, whether prescription or over-the-counter, such as aspirin, ibuprofen, or naproxen.

Healthcare providers should exercise caution when prescribing this product to geriatric patients, especially if they consume three or more alcoholic drinks daily while using the medication. It is essential to monitor these patients closely for any signs of gastrointestinal bleeding. Additionally, dosage adjustments may be necessary for elderly patients, particularly if they are taking higher doses or using the product for an extended duration beyond the recommended guidelines.

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 the unborn child and complications during delivery. Therefore, it is crucial that pregnant patients only use aspirin under the guidance of a physician 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 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 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 is contraindicated, 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 an elevated 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. Immediate medical assistance should be sought, and healthcare professionals are advised to contact the Poison Control Center at 1-800-222-1222 without delay.

Timely intervention is crucial for both adults and children, even in the absence of observable signs or symptoms. Healthcare providers should remain vigilant and proactive in managing potential overdose situations to mitigate risks and ensure patient safety.

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

No postmarketing experience details are provided in the insert for Goodys Extra Strength (acetaminophen, aspirin, and caffeine powder).

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 the Poison Control Center at 1-800-222-1222, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Patients should be cautioned against using the medication if they have a history of allergic reactions to aspirin or any other pain reliever or fever reducer. It is important to inform patients that they should 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 with a doctor or pharmacist.

Patients should be instructed 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, patients should be advised to stop use and consult a doctor if their pain worsens or lasts longer than 10 days, if their fever intensifies or persists beyond 3 days, if they observe any redness or swelling, or if any new symptoms arise. They should also be informed that ringing in the ears or loss of hearing may signal a serious condition, warranting immediate medical attention.

Patients with liver disease, a history of stomach problems (such as heartburn), high blood pressure, heart disease, liver cirrhosis, or kidney disease should be encouraged to consult a doctor before using this medication. Furthermore, patients taking diuretics or those with asthma should also seek medical advice prior to use. Lastly, patients on prescription medications for diabetes, gout, or arthritis should be advised to consult with a doctor or pharmacist before using this product.

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 any degradation of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

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