Pain Terminator

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, muscular aches, arthritis pain, the common cold, toothache, and premenstrual or menstrual cramps.

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage and administration guidelines. It is imperative not to exceed the directed dosage. Each dose should be accompanied by a full glass of water to ensure proper ingestion.

For adults and children aged 12 years and older, the recommended dosage is 2 caplets every 6 hours as needed. The total daily limit should not exceed 8 caplets within a 24-hour period.

For children under 12 years of age, it is advised to consult a physician for appropriate dosing recommendations.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, is prohibited due to the risk of acetaminophen overdose. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

• The product should not be used in individuals with a history of allergic reactions to acetaminophen, aspirin, or any other pain relievers or fever reducers, as this may lead to severe allergic reactions.

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.

Acetaminophen, a component of this product, has been associated with severe skin reactions. Symptoms may include skin reddening, blisters, and rash. In the event of a skin reaction, the use of the product should be discontinued immediately, and medical assistance should be sought.

Aspirin, classified as a nonsteroidal anti-inflammatory drug (NSAID), may provoke severe allergic reactions. Symptoms of such reactions can include hives, facial swelling, asthma (wheezing), and shock. Immediate medical attention is warranted if any of these symptoms occur.

This product contains acetaminophen, and caution is advised due to the potential for severe liver damage. This risk is heightened if the maximum daily dosage of 8 caplets is exceeded, if other medications containing acetaminophen are taken concurrently, or if the product is used in conjunction with the consumption of three or more alcoholic drinks daily.

The presence of an NSAID in this product raises concerns regarding stomach bleeding, particularly in individuals aged 60 or older, those with a history of stomach ulcers or bleeding problems, and those taking anticoagulants or steroid medications. The risk is also increased with the concurrent use of other NSAIDs (including aspirin, ibuprofen, or naproxen), prolonged use beyond the recommended duration, or the consumption of three or more alcoholic drinks daily.

Caffeine is also present in the recommended dosage of this product, which is comparable to the caffeine content of a cup of coffee. It is advisable to limit the intake of other caffeine-containing medications, foods, or beverages while using this product, 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 any of the following conditions apply: a history of stomach bleeding, high blood pressure, heart disease, liver cirrhosis, kidney disease, or if they are taking diuretics. Additionally, individuals with a history of stomach problems such as heartburn, asthma, or liver disease should seek medical advice before use.

Patients should also be encouraged to consult a doctor or pharmacist if they are taking prescription medications for gout, diabetes, or arthritis, or if they are under medical care for any serious condition.

In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended. Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Patients should discontinue use and contact 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 consultation include worsening fever lasting more than three days, ringing in the ears or loss of hearing, redness or swelling in a painful area, or the emergence of any new symptoms, 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 are also a concern. Acetaminophen, one of the components of this product, may lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, patients are advised to discontinue use and seek medical assistance promptly. Similarly, aspirin, another ingredient, may provoke severe allergic reactions characterized by hives, facial swelling, asthma (wheezing), or shock.

Liver damage is a significant risk associated with the use of this product, particularly if patients exceed the maximum daily dosage of 8 caplets, use other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Additionally, the product contains an NSAID, which may increase the risk of severe stomach bleeding. This 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 should be cautious not to exceed the recommended duration of use or dosage, as well as limit alcohol consumption.

Caffeine is also present in the recommended dose, which is comparable to that found in a cup of coffee. Patients should limit the intake of other caffeine-containing products to avoid potential side effects such as nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Patients are advised to 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, ringing in the ears or loss of hearing, redness or swelling in painful areas, or the emergence of any new symptoms, as these may indicate a serious condition.

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 Pain Terminator (caffeine, acetaminophen, aspirin). 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 children under 12 years of age, it is advised to consult a doctor before use. The product should be kept out of reach of children. In the event of an overdose, immediate medical attention is necessary; contacting a Poison Control Center is recommended, as prompt medical intervention is critical for both adults and children, even if no signs or symptoms are apparent.

For adolescents aged 12 years and older, the recommended dosage is 2 caplets every 6 hours as needed, with a maximum of 8 caplets in a 24-hour period.

Geriatric Use

Elderly patients, particularly those aged 60 years and older, may have an increased risk of stomach bleeding when using this product. It is essential for healthcare providers to exercise caution and consider this risk when prescribing to geriatric patients. Additionally, this product contains acetaminophen, and severe liver damage may occur if patients consume three or more alcoholic drinks daily while using it.

Before initiating treatment, healthcare providers should advise elderly patients to consult a physician if they have a history of stomach bleeding, high blood pressure, heart disease, liver cirrhosis, or kidney disease. Monitoring for signs of stomach bleeding is crucial; patients should be instructed to discontinue use and seek medical attention if they experience symptoms such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain.

Furthermore, healthcare providers should be aware that if pain worsens or persists for more than 10 days, or if fever worsens or lasts more than 3 days, patients should seek medical advice. Other concerning symptoms include ringing in the ears, loss of hearing, redness or swelling in the painful area, or the emergence of any new symptoms. Close monitoring and appropriate dose modifications may be necessary to ensure the safety and efficacy of treatment in geriatric patients.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to use. The use of aspirin during pregnancy, particularly at or after 20 weeks gestation, is associated with potential risks. Specifically, it may lead to adverse effects on fetal outcomes or complications during delivery. Therefore, aspirin should only be used in this period if explicitly directed by a healthcare provider.

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 comorbid 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 degree of renal impairment.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical that patients do not exceed the maximum daily dosage of 8 caplets within a 24-hour period. Additionally, patients should avoid concomitant use with other medications containing acetaminophen, as this may further increase the risk of liver injury.

Patients with compromised liver function are advised to consult a healthcare professional prior to use, particularly if they have a history of liver disease, liver cirrhosis, high blood pressure, heart disease, or kidney disease. Furthermore, consumption of three or more alcoholic drinks daily while using this product is strongly discouraged, as it may exacerbate the risk of liver damage. Regular monitoring of liver function may be warranted in patients with existing liver conditions to ensure safety and efficacy during treatment.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt medical intervention is crucial for both adults and children, even in the absence of observable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, it is essential to monitor the patient closely and provide comprehensive care as needed.

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 provided in the available data. Furthermore, there are no specific findings related to animal pharmacology and toxicology mentioned.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. Notable severe skin reactions have been associated with acetaminophen, including skin reddening, blisters, and rash. Additionally, severe allergic reactions linked to aspirin (NSAIDs) have been reported, which include hives, facial swelling, asthma (wheezing), and shock.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, it is crucial to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

Patients should be informed not to use this medication in conjunction with any other drug that contains 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.

It is important to discuss the potential for allergic reactions. Patients should not use this medication if they have ever experienced an allergic reaction to acetaminophen, aspirin, or any other pain relievers or fever reducers. They should be instructed to stop use and seek medical attention immediately if any signs of an allergic reaction occur.

Healthcare providers should also inform patients to discontinue use 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 stomach pain that does not improve. Additional symptoms warranting medical consultation include worsening pain lasting more than 10 days, fever persisting for more than 3 days, ringing in the ears or loss of hearing, redness or swelling in a painful area, or the emergence of any new symptoms, as these could indicate a serious condition.

Patients should be advised to consult a doctor before using this medication if they have a history of stomach bleeding, high blood pressure, heart disease, liver cirrhosis, or kidney disease. Additionally, they should seek medical advice if they are taking a diuretic, have a history of stomach problems such as heartburn, or have asthma or liver disease.

Finally, patients should be encouraged to speak with a doctor or pharmacist before using this medication if they are taking any prescription drugs for gout, diabetes, or arthritis, or if they are under a doctor's care for any serious condition.

Storage and Handling

The product is supplied in tamper-evident sealed packets to ensure integrity and safety. It is essential to store the packets at room temperature, specifically within the range of 68º-77ºF (20º-25ºC). Care should be taken to avoid exposure to excessive heat and humidity, as these conditions may compromise the product's quality. Opened or torn packets should not be used to maintain the efficacy and safety of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)