Splizz Pain Reliever - Orange-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, characterized by an orange appearance.

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

Healthcare professionals should advise patients to adhere strictly to the recommended dosage. For adults and children aged 12 years and older, the prescribed dosage is to fully dissolve 2 tablets in a glass of water and consume the solution every 6 hours as needed. It is imperative not to exceed 8 tablets within a 24-hour period.

For children under 12 years of age, the use of this medication is not recommended.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to acetaminophen, 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 have or are recovering from chickenpox or flu-like symptoms should not use this product. If behavioral changes accompanied by nausea and vomiting occur during use, it is imperative to consult a physician, as these symptoms may indicate the onset of Reye's syndrome, a rare but serious condition.

Acetaminophen, a component of this product, has the potential to cause severe skin reactions. Symptoms may include skin reddening, blisters, and 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, and severe liver damage may result from exceeding the maximum daily dosage of 4000 mg within a 24-hour period, using other medications that also contain acetaminophen, or consuming 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 duration or dosage of the product.

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 stomach bleeding warning is applicable, 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 assistance should be sought, or the Poison Control Center should be contacted without delay.

Patients should discontinue use and contact a physician 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 10 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 may experience a range of adverse reactions, which can be categorized by seriousness and frequency.

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.

Severe allergic reactions have been reported, particularly associated with acetaminophen and aspirin. Symptoms of severe skin reactions to acetaminophen may include skin reddening, blisters, and rash. In the event of a skin reaction, patients are advised to discontinue use and seek medical assistance promptly. Aspirin may provoke severe allergic reactions characterized by hives, facial swelling, asthma (wheezing), and shock.

The product contains acetaminophen, which poses a risk of severe liver damage if patients exceed 4000 mg in 24 hours, take it in conjunction with other acetaminophen-containing medications, or consume three or more alcoholic drinks daily while using this product.

Additionally, the presence of an NSAID in this product raises concerns regarding severe stomach bleeding. The risk is heightened in patients aged 60 or older, those with a history of stomach ulcers or bleeding problems, individuals taking anticoagulants or steroid medications, and those consuming three or more alcoholic drinks daily. Patients should also be cautious if they take other medications containing NSAIDs, such as aspirin, ibuprofen, or naproxen, or if they exceed the recommended dosage or duration of use.

Patients should be aware of the caffeine content in the recommended dose, which is comparable to that of a cup of coffee. It is advisable 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 are instructed to stop use and consult 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), ringing in the ears or loss of hearing, redness or swelling in a painful area, worsening pain lasting more than 10 days, fever that worsens or lasts more than three 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 carries a risk of severe gastrointestinal bleeding. The risk is significantly increased when used in conjunction with anticoagulants or steroid medications. Additionally, concurrent use with other prescription or nonprescription NSAIDs, such as aspirin, ibuprofen, or naproxen, may further elevate this risk.

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. Monitoring for potential adverse effects is recommended in these cases.

Packaging & NDC

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

Pediatric Use

Pediatric patients, including children and teenagers, should not use this product if they have or are recovering from chicken pox or flu-like symptoms. It is important to monitor for changes in behavior accompanied by nausea and vomiting during use, as these may indicate the onset of Reye's syndrome, a rare but serious condition.

For dosing, adults and children aged 12 years and older are advised to take 2 tablets every 6 hours, with a maximum of 8 tablets in a 24-hour period. This product is not recommended for children under 12 years of age.

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, those who are concurrently using blood thinners (anticoagulants) or steroid medications, and patients taking other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin, ibuprofen, or naproxen.

Additionally, the risk of stomach bleeding is amplified in geriatric patients who consume three or more alcoholic drinks daily while using this product, or who exceed the recommended dosage or duration of use. Therefore, careful monitoring and consideration of these factors are essential when prescribing this medication to elderly patients. Dose adjustments may be necessary based on individual risk profiles to ensure safety and minimize potential adverse effects.

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 before using this medication. It is particularly important to avoid the use of aspirin during the last three months of pregnancy 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 while breastfeeding.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have 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. The presence of liver disease may increase the risk of adverse effects, particularly due to the acetaminophen content.

Severe liver damage may occur if patients exceed the maximum recommended dosage of 4000 mg in a 24-hour period. Additionally, caution is advised against the concurrent use of other medications containing acetaminophen, as this may further elevate the risk of liver injury.

Patients who consume three or more alcoholic drinks daily should also exercise caution when using this product, as alcohol can exacerbate the potential for liver damage. Regular monitoring of liver function may be warranted in patients with compromised liver function to ensure safety and efficacy.

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 aware that the symptoms of overdose may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management of an overdose typically involves supportive care and symptomatic treatment. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where specific antidotes are available, their administration should be considered based on the clinical scenario and the substance involved.

It is essential for healthcare providers to remain vigilant and prepared to implement emergency protocols in the event of an overdose, ensuring the best possible outcomes for affected individuals.

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. 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. Additionally, they should not use this product 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. They should also be advised to discontinue 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. Furthermore, if a fever worsens or persists for more than 3 days, or if any new symptoms arise, patients should be directed to seek medical attention, as these may indicate a serious condition.

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. Additionally, those taking diuretics, individuals with asthma, or patients 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. Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

The route of administration for the medication is oral. Clinicians should advise patients who are pregnant or breastfeeding to consult a healthcare professional prior to use. It is particularly crucial to avoid aspirin during the last trimester of pregnancy unless specifically directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery.

Drug Information (PDF)

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

View product document (PDF)