Goodys Extra Strength

Description

Goody’s® EXTRA STRENGTH HEADACHE POWDERS contain a combination of acetaminophen, aspirin (a nonsteroidal anti-inflammatory drug), and caffeine, functioning as a pain reliever and pain reliever aid. Each box includes 24 envelopes, with each envelope containing 6 powders.

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. Additionally, it is indicated for the temporary reduction of fever.

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 place one powder on the tongue every six hours, as long as symptoms persist. Each dose should be accompanied by a full glass of water, or the powder may be stirred into a glass of water or another suitable liquid for administration.

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

For children under 12 years of age, consultation with a doctor is recommended prior to use.

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 provoke severe allergic reactions. Symptoms of such reactions can include hives, facial swelling, shock, and asthma (wheezing). Immediate medical attention should be sought if any of these symptoms occur.

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding four powders 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 a nonsteroidal anti-inflammatory drug (NSAID) in this product 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 issues, 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.

Healthcare professionals should advise patients to consult a doctor prior to use if they have liver disease, if the stomach bleeding warning is applicable, if they have a history of stomach problems such as heartburn, or if they have conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. Additionally, patients taking diuretics or those with asthma should seek medical advice before using this product. It is also recommended that patients consult a doctor or pharmacist if they are currently taking prescription medications for diabetes, gout, or arthritis.

Patients should discontinue use and contact a healthcare provider 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, visible 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 occur, presenting as hives, facial swelling, shock, or asthma (wheezing). Patients experiencing any signs of an allergic reaction should seek medical help immediately.

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

Additionally, the presence of a nonsteroidal anti-inflammatory drug (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, are taking anticoagulants or steroid drugs, or are using other NSAIDs. Patients should be cautioned against exceeding the recommended dosage or duration of use.

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 worsening pain lasting more than 10 days, fever lasting more than 3 days, redness or swelling, the appearance of new symptoms, or ringing in the ears or loss of hearing, as these could indicate a serious condition.

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, or kidney disease, are taking diuretics, or have asthma.

Drug Interactions

Taking other medications that contain acetaminophen, whether prescription or nonprescription, may result in severe liver damage if the total intake exceeds four powders within a 24-hour period. It is crucial for healthcare providers to monitor patients for signs of liver toxicity in those who may be using multiple acetaminophen-containing products.

The concomitant use of blood thinners (anticoagulants), steroids, or other nonsteroidal anti-inflammatory drugs (NSAIDs) such as aspirin, ibuprofen, or naproxen increases the risk of severe stomach bleeding. Patients should be advised to exercise caution and consult with a healthcare professional before combining these medications.

Patients taking prescription medications for diabetes, gout, or arthritis should seek guidance from a healthcare provider or pharmacist prior to using this product to avoid potential interactions that may affect their treatment regimen.

Additionally, it is recommended to limit the intake of caffeine-containing drugs, foods, or beverages while using this product. Excessive caffeine consumption may lead to adverse effects such as nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat. Monitoring caffeine intake is advised to mitigate these risks.

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 chicken pox or flu-like symptoms should not use this product due to the risk of Reye’s syndrome. Healthcare professionals should advise parents to consult a doctor if their child exhibits changes in behavior accompanied by nausea and vomiting, as these may be early signs of Reye’s syndrome.

For dosing, the recommended administration for adults and children aged 12 years and older is to place 1 powder on the tongue every 6 hours while symptoms persist, with a maximum of 4 powders in a 24-hour period unless otherwise directed by a physician. For children under 12 years of age, it is recommended to seek medical advice before use.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk of severe stomach bleeding. This risk is further heightened in individuals with a history of stomach ulcers or bleeding problems. Caution is advised for geriatric patients who are concurrently using blood thinners (anticoagulants) or steroid medications, as well as those taking other drugs that contain non-steroidal anti-inflammatory drugs (NSAIDs), including prescription and over-the-counter options such as aspirin, ibuprofen, and naproxen.

Additionally, the risk of stomach bleeding is amplified in elderly patients who consume three or more alcoholic drinks daily while using this product. It is crucial for healthcare providers to monitor these patients closely and to consider dose modifications if they are taking the medication for longer than directed or at higher doses than recommended. Careful assessment and management of these factors are essential to ensure the safety of geriatric patients.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to use. 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, 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 in lactating individuals.

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 not exceed four powders within a 24-hour period, as this represents the maximum daily dosage. Additionally, patients must avoid concurrent use with other medications that contain acetaminophen, as this can further increase the risk of liver injury.

Furthermore, patients with compromised liver function should be cautious about alcohol consumption while using this product. The consumption of three or more alcoholic drinks per day is contraindicated, as it may exacerbate the potential for liver damage. Regular monitoring of liver function may be warranted in patients with existing liver disease 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.

Both adults and children require swift medical attention following an overdose, regardless of whether any signs or symptoms are observed. Early recognition and management of an overdose can significantly impact 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 should be informed not to use this product if they have ever experienced an allergic reaction to aspirin or any other pain reliever or fever reducer.

It is essential to counsel patients against using this medication in conjunction with any other drug that contains acetaminophen, whether prescription or nonprescription. If patients are uncertain about the contents of a medication, they should be encouraged to consult a doctor or pharmacist for clarification.

Patients should be instructed to stop using the product and seek medical attention immediately if they experience any signs of an allergic reaction. Additionally, they should be made aware of the symptoms indicative of stomach bleeding, which include feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. If pain worsens or persists for more than 10 days, or if fever intensifies or lasts longer than 3 days, patients should be advised to discontinue use and consult a doctor. They should also be informed to seek medical advice if they notice any redness or swelling, new symptoms, or if they experience ringing in the ears or a loss of hearing, as these may signal a serious condition.

While using this product, patients should limit their intake of caffeine-containing drugs, foods, or beverages, as excessive caffeine may lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat. It is important to note that the recommended dose of this product contains approximately the same amount of caffeine as a cup of coffee.

Patients should be encouraged to consult a doctor before using this medication if they have liver disease, if the warning regarding stomach bleeding applies to them, or if they have a history of stomach problems such as heartburn. 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 product. Lastly, patients should be encouraged to speak with a doctor or pharmacist if they are currently taking a prescription drug for diabetes, gout, or arthritis.

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 Extra Strength, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)