Publix Fast Relief Effervescent - Original Flavor

Description

SPL code 34089-3 corresponds to Publix Pain 36. This product is formulated for the management of pain and is available in a specific dosage form. Further details regarding its composition, including active and inactive ingredients, are essential for comprehensive understanding and application in clinical settings.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, muscle pain, backache, toothache, menstrual pain, colds, and minor arthritis pain. Additionally, it is indicated for the temporary reduction of fever.

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

Dosage and Administration

The recommended dosage for adults and children aged 12 years and older is two tablets every four hours, as needed, not to exceed eight tablets within a 24-hour period. For individuals aged 60 years and older, the dosage remains two tablets every four hours, or as directed by a healthcare professional, with a maximum limit of four tablets in a 24-hour period.

For children under 12 years of age, it is advised to consult a healthcare professional for appropriate dosing guidance.

To prepare the medication, place two tablets in 4 ounces of water. It is essential to ensure that the tablets are completely dissolved before consumption. The product can be taken at any time of day—morning, noon, or night—when relief from headaches, backaches, body aches, or muscle pain is required.

Healthcare professionals should instruct patients that they do not need to consume any residue that may remain at the bottom of the glass, as the active ingredients are fully dissolved in the water. It is crucial to adhere to the recommended dosages to avoid serious injury.

Contraindications

Use of this product is contraindicated in individuals with a known allergy to aspirin or any other pain reliever or fever reducer. Additionally, it should not be used in patients who have a history of allergic reactions to this product or any of its ingredients.

Warnings and Precautions

Use of this product is associated with several important warnings and precautions that healthcare professionals should communicate to patients.

Reye’s Syndrome Children and teenagers who are experiencing or recovering from chickenpox or flu-like symptoms should not use this product. If patients exhibit changes in behavior accompanied by nausea and vomiting while using this product, they should be advised to consult a physician immediately, as these symptoms may indicate the onset of Reye’s syndrome, a rare but serious condition.

Allergy Alert Aspirin can provoke severe allergic reactions in some individuals. Symptoms may include hives, facial swelling, asthma (wheezing), and in extreme cases, shock. Patients should be informed of these potential reactions and advised to seek immediate medical attention if they occur.

Stomach Bleeding Warning This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of this adverse effect increases in patients who:

• Are aged 60 years or older

• Have a history of stomach ulcers or bleeding disorders

• Are concurrently using blood thinners (anticoagulants) or steroid medications

• Are taking other medications that contain NSAIDs, whether prescription or over-the-counter (e.g., aspirin, ibuprofen, naproxen)

• Consume three or more alcoholic beverages daily while using this product

• Exceed the recommended dosage or duration of use

Monitoring and Consultation Patients should be instructed to discontinue use and seek medical advice 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. Additionally, they should consult a healthcare provider if they experience an allergic reaction, if pain persists for more than 10 days or worsens, if fever intensifies or lasts longer than three days, if new symptoms arise, if redness or swelling occurs, or if they experience ringing in the ears or hearing loss.

Emergency Medical Help In the event of an allergic reaction, patients must be advised to seek emergency medical assistance immediately.

Side Effects

Patients using this product should be aware of several serious adverse reactions associated with its use. Notably, Reye’s syndrome is a rare but serious illness that can occur in children and teenagers who have or are recovering from chickenpox or flu-like symptoms. If patients experience changes in behavior accompanied by nausea and vomiting while using this product, they should consult a doctor immediately, as these may be early signs of Reye’s syndrome.

Additionally, the product carries an allergy alert, as aspirin may induce severe allergic reactions. Symptoms of such reactions can include hives, facial swelling, asthma (wheezing), and shock. Patients experiencing any signs of an allergic reaction should seek medical help right away.

The product contains a nonsteroidal anti-inflammatory drug (NSAID), which may lead to severe stomach bleeding. The risk of this adverse reaction is heightened in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid medications, consume three or more alcoholic drinks daily while using the product, or exceed the recommended dosage or duration of use.

Patients should 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 persistent stomach pain. Furthermore, if pain lasts longer than 10 days or worsens, if fever persists or worsens beyond three days, if new symptoms arise, if redness or swelling occurs, or if there is ringing in the ears or loss of hearing, medical advice should be sought.

Before using this product, patients should consult a doctor if any of the following apply: they have a history of stomach problems such as heartburn, high blood pressure, heart disease, liver cirrhosis, or kidney disease; they are taking diuretics; they have asthma; or they are on a sodium-restricted diet. It is also advisable for patients to consult a doctor or pharmacist if they are taking prescription medications for diabetes, gout, or arthritis.

Drug Interactions

Taking this product may lead to an increased risk of gastrointestinal bleeding when used concurrently with anticoagulants or steroid medications. Healthcare professionals should exercise caution and consider monitoring patients for signs of bleeding.

Additionally, the concomitant use of this product with other nonsteroidal anti-inflammatory drugs (NSAIDs), including prescription and nonprescription options such as aspirin, ibuprofen, or naproxen, may also elevate the risk of stomach bleeding. It is advisable to assess the necessity of dosage adjustments or enhanced monitoring for patients using these combinations.

Patients are encouraged to consult with a healthcare provider or pharmacist prior to using this product if they are currently prescribed medications for diabetes, gout, or arthritis, to ensure safe and effective use.

No specific interactions with laboratory tests have been identified in the available data.

Packaging & NDC

Below are the non-prescription pack sizes of Publix Fast Relief Effervescent - Original Flavor (aspirin). 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, 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 over are directed to take 2 tablets every 4 hours, not to exceed 8 tablets in a 24-hour period. 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 for severe stomach bleeding. This heightened risk necessitates careful consideration when prescribing medications that may contribute to gastrointestinal complications.

For geriatric patients, the recommended dosage is 2 tablets every 4 hours, or as directed by a healthcare provider. It is crucial that these patients do not exceed a total of 4 tablets within a 24-hour period to minimize the risk of adverse effects.

Healthcare providers should closely monitor elderly patients for any signs of gastrointestinal bleeding and adjust treatment plans accordingly to ensure safety and efficacy.

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 qualified 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 its use during lactation.

Renal Impairment

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider individual patient factors when treating patients with renal impairment, as the absence of detailed guidance necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

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 specific symptoms of an 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 the specific substance is known, targeted interventions may be employed to counteract the effects of the overdose.

It is essential for healthcare providers to remain vigilant and act swiftly in the management of overdose situations to ensure optimal patient outcomes.

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

Postmarketing Experience

Postmarketing experience has revealed reports of various adverse reactions associated with the use of this product. Notable among these are allergic reactions, which include hives, facial swelling, asthma (wheezing), and shock. Additionally, instances of stomach bleeding have been reported, particularly in patients who are older, have a history of stomach ulcers or bleeding problems, or are concurrently using other nonsteroidal anti-inflammatory drugs (NSAIDs) or anticoagulants.

Furthermore, there have been reports of Reye’s syndrome in children and teenagers who have or are recovering from chickenpox or flu-like symptoms following the use of this product.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. Patients should be informed not to use the product if they have a known allergy to aspirin or any other pain reliever or fever reducer, or if they have ever experienced an allergic reaction to this product or any of its ingredients.

It is important for healthcare providers to instruct patients to stop using the product and seek medical attention 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. Patients should also be made aware that they should seek immediate medical help if they experience an allergic reaction, if pain persists for more than 10 days or worsens, if fever worsens or lasts more than 3 days, if new symptoms arise, if redness or swelling occurs, or if they experience ringing in the ears or a loss of hearing.

Providers should emphasize the importance of adhering to the recommended dosage and advise patients not to exceed this dosage while using the product. Additionally, patients should be encouraged to consult with their healthcare provider before use if they have a history of stomach problems (such as heartburn), high blood pressure, heart disease, liver cirrhosis, or kidney disease, or if they are taking a diuretic, have asthma, or are on a sodium-restricted diet.

Finally, healthcare providers should recommend that patients ask a doctor or pharmacist before using the product if they are currently taking a prescription medication for diabetes, gout, or arthritis to avoid potential interactions.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at room temperature, within the range of 59ºF to 86ºF (15ºC to 30ºC). Care should be taken to avoid exposure to excessive heat, which may compromise the integrity of the product. Proper container requirements must be adhered to, ensuring that the product is kept in a suitable environment to maintain its efficacy. Special handling needs should be observed to ensure optimal storage conditions are met.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Publix Fast Relief Effervescent - Original Flavor, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)