Splizz Pain Reliever - Grapefruit-Flavored

Description

Acetaminophen, Aspirin (NSAID), and Caffeine are the active ingredients in this formulation. The product is presented in the form of 20 effervescent tablets, which are designed to dissolve in water prior to administration. Additionally, the formulation includes red grapefruit as an ingredient, contributing to the overall composition.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, cold symptoms, arthritis, backache, muscular aches, toothache, and premenstrual or menstrual cramps.

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

Dosage and Administration

To prepare the medication, fully dissolve 2 tablets in a glass of water and consume the solution.

For adults and children aged 12 years and older, the recommended dosage is 2 tablets every 6 hours, with a maximum limit of 8 tablets within a 24-hour period.

This medication is not indicated for use in children under 12 years of age.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to acetaminophen, aspirin, or any other pain reliever or fever reducer. Additionally, this product should not be used concurrently with any other medication containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

Warnings and Precautions

Children and teenagers who have or are recovering from chickenpox or flu-like symptoms should not use this product. If any changes in behavior accompanied by nausea and vomiting occur while using this product, it is imperative to consult a physician, as these symptoms may indicate the onset of Reye's syndrome, a rare but serious condition.

This product contains acetaminophen, which has the potential to cause severe skin reactions. Symptoms may include skin reddening, blisters, or rash. Should any skin reaction occur, the user must discontinue use immediately and seek medical assistance.

Severe liver damage may result from the consumption of this product if the following conditions are met: exceeding 4000 mg of acetaminophen within a 24-hour period, concurrent use with other medications containing acetaminophen, or the consumption of three or more alcoholic drinks daily while using this product.

Additionally, this product contains a nonsteroidal anti-inflammatory drug (NSAID), which may lead to severe stomach bleeding. The risk of such an event is heightened in individuals who are 60 years of age or older, have a history of stomach ulcers or bleeding disorders, 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.

The recommended dose of this product contains approximately the same amount of caffeine as a standard cup of coffee. Therefore, 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 symptoms such as nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Healthcare professionals should advise patients to consult a physician prior to use if they have liver disease, if the warning regarding stomach bleeding applies, if they have a history of gastrointestinal issues such as heartburn, or if they have conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. Patients taking diuretics, those with asthma, or individuals on a sodium-restricted diet should also seek medical advice before use. Furthermore, it is essential to consult a doctor or pharmacist if the patient is taking prescription medications for diabetes, gout, or arthritis, or if they are under medical care for any serious condition.

In the event of an overdose, immediate medical attention should be sought, or the Poison Control Center should be contacted without delay.

Patients should discontinue use and contact a healthcare provider if they experience any allergic reactions, signs of stomach bleeding (such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain), ringing in the ears or loss of hearing, redness or swelling in a painful area, worsening pain lasting more than ten days, fever that worsens or persists for more than three days, or any new symptoms that may indicate a serious condition.

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 chicken pox or flu-like symptoms. Patients should not use this product in such cases, and if changes in behavior accompanied by nausea and vomiting occur, medical consultation is advised as these may be early signs of Reye's syndrome.

Severe skin reactions have been reported in patients taking acetaminophen, which may manifest as skin reddening, blisters, or rash. If any of these symptoms occur, patients should discontinue use and seek medical assistance immediately. Additionally, aspirin may provoke severe allergic reactions, including hives, facial swelling, asthma (wheezing), and shock.

The product contains acetaminophen, and patients should be cautioned about the risk of severe liver damage, which can occur if they exceed 4000 mg in 24 hours, use other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Patients should also be aware of the risk of severe stomach bleeding associated with the NSAID component of this product. The likelihood of this adverse reaction increases in individuals aged 60 or older, those with a history of stomach ulcers or bleeding problems, and those taking blood thinners, steroids, or other NSAIDs. Consumption of three or more alcoholic drinks daily while using this product or taking it for longer than directed may further elevate this risk.

Caffeine is present in the recommended dose of this product, which is comparable to that found in a cup of coffee. Patients are advised to limit the intake of other caffeine-containing medications, foods, or beverages, as excessive caffeine may lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Patients should stop using the product and consult a doctor 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), ringing in the ears or loss of hearing, redness or swelling in a painful area, worsening pain lasting more than 10 days, fever lasting more than 3 days, or any new symptoms that may suggest a serious condition.

Drug Interactions

Severe liver damage may occur with the use of this product containing acetaminophen if the maximum daily dosage of 4000 mg is exceeded within a 24-hour period or if it is taken concurrently with other medications that also contain acetaminophen.

This product also contains a nonsteroidal anti-inflammatory drug (NSAID), which has the potential to cause severe gastrointestinal bleeding. The risk of such bleeding is increased when used in conjunction with anticoagulants or steroid medications. Additionally, caution is advised if this product is taken alongside other prescription or nonprescription NSAIDs, including but not limited to aspirin, ibuprofen, or naproxen.

Patients are advised to consult with a healthcare professional prior to using this product if they are currently taking prescription medications for diabetes, gout, or arthritis to ensure safe and effective use.

Packaging & NDC

Below are the non-prescription pack sizes of Splizz Pain Reliever - Grapefruit-Flavored (acetaminophen, aspirin, and caffeine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients, particularly those under 12 years of age, should not use this product. It is contraindicated in children and teenagers who have or are recovering from chickenpox or flu-like symptoms.

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

Healthcare professionals should be vigilant for changes in behavior accompanied by nausea and vomiting in pediatric patients using this product, as these symptoms may indicate the onset of Reye's syndrome, a rare but serious condition. Consultation with a physician is advised if such symptoms occur.

Geriatric Use

Elderly patients, particularly those aged 60 and older, may have an increased risk of severe stomach bleeding. Healthcare providers should exercise caution when prescribing this medication to geriatric patients, considering the potential for heightened adverse effects.

It is advisable to closely monitor elderly patients for any signs of gastrointestinal bleeding and to evaluate the necessity of dosage adjustments based on individual patient factors. Careful assessment of the risk-benefit profile is essential in this population to ensure safe and effective use of the medication.

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 healthcare professional prior to using this medication. It is particularly important to avoid the use of aspirin during the last three months of pregnancy unless explicitly 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 while breastfeeding.

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 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 4000 mg of acetaminophen in a 24-hour period, which is the maximum recommended daily amount, 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 an elevated risk for severe liver complications. Therefore, careful consideration and monitoring of liver function are advised for patients with compromised liver health.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be vigilant for symptoms that may arise from an overdose, although specific symptoms are not detailed in the provided information. The management of an overdose typically involves supportive care and symptomatic treatment, tailored to the individual patient's needs.

It is essential for healthcare providers to remain informed about the appropriate protocols for managing overdose situations, ensuring that patients receive timely and effective care.

Nonclinical Toxicology

It is especially important not to use aspirin during the last three months of 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 the following adverse reactions reported voluntarily or through surveillance programs. Severe skin reactions, including skin reddening, blisters, and rash, have been associated with acetaminophen. Additionally, severe allergic reactions, such as hives, facial swelling, asthma (wheezing), and shock, have been reported in association with aspirin.

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, patients should be instructed to seek medical help or contact a Poison Control Center immediately.

Patients must be informed not to use this medication if they have ever experienced an allergic reaction to acetaminophen, aspirin, or any other pain reliever or fever reducer. It is crucial to avoid using 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.

Patients should be instructed to stop using the medication 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, they should be advised to stop use and consult a doctor if they experience ringing in the ears, loss of hearing, redness or swelling in the painful area, or if their pain worsens or lasts longer than 10 days. If a fever worsens or persists for more than 3 days, or if any new symptoms arise that could indicate a serious condition, patients should also seek medical advice.

Patients with liver disease, a history of stomach problems (such as heartburn), high blood pressure, heart disease, liver cirrhosis, or kidney disease should be advised to consult a doctor before using this medication. Furthermore, patients taking diuretics, those with asthma, or those on a sodium-restricted diet should also seek medical advice prior to use. It is important for patients to discuss any prescription medications they are taking for diabetes, gout, or arthritis with their doctor or pharmacist, as well as any other drugs or serious medical conditions they may have.

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 room temperature, maintaining a range of 59°F to 86°F (15°C to 30°C). Proper storage conditions are crucial to ensure the integrity and efficacy of the product. No special handling requirements are noted; however, adherence to the specified temperature range is recommended to preserve quality.

Additional Clinical Information

The medication is administered orally, with specific dosing guidelines for different age groups. Adults and children aged 12 years and older are advised to take 2 tablets every 6 hours, not exceeding 8 tablets within a 24-hour period. The use of this medication is not recommended for children under 12 years of age.

Clinicians should counsel patients regarding the use of this medication during pregnancy or breastfeeding. It is particularly crucial to avoid aspirin in the last trimester of pregnancy unless explicitly directed by a healthcare professional, as it may pose risks to the unborn child or lead to complications during delivery. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)