Winco Foods Effervescent Pain Relief

Description

Winco Pain 36 is identified by the SPL code 34089-3. This product is formulated for the management of pain. Further details regarding its composition, dosage form, and specific indications are not provided in the extracted information.

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

Adults and children aged 12 years and older are advised to take 2 tablets every 4 hours, or as directed by a healthcare professional. The maximum dosage should not exceed 8 tablets within a 24-hour period. For individuals aged 60 years and older, the recommended dosage is also 2 tablets every 4 hours, with a maximum limit of 4 tablets in a 24-hour period.

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

To prepare the medication, place 2 tablets in 4 ounces of water and ensure that the tablets are completely dissolved before ingestion. 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 needed. It is important to note that any residue remaining at the bottom of the glass does not need to be consumed, as the active ingredients are fully dissolved in the water.

Healthcare professionals should emphasize the importance of not exceeding the recommended dosage 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

The use of this product necessitates careful consideration of several critical warnings and precautions to ensure patient safety.

Reye’s Syndrome Children and teenagers who are experiencing or recovering from chickenpox or flu-like symptoms should avoid using this product. If any changes in behavior accompanied by nausea and vomiting occur during use, it is imperative to consult a healthcare professional, as these symptoms may indicate the onset of Reye’s syndrome, a rare but serious condition.

Allergy Alert Aspirin has the potential to induce severe allergic reactions. Symptoms may include hives, facial swelling, asthma (wheezing), and shock. Immediate medical attention is required if an allergic reaction is suspected.

Stomach Bleeding Warning This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may increase the risk of severe stomach bleeding. The likelihood of this adverse effect is heightened in individuals who:

• Are aged 60 years or older

• Have a history of stomach ulcers or bleeding disorders

• Are concurrently using anticoagulants or steroid medications

• Are taking other 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 Parameters Healthcare professionals should monitor patients for signs of stomach bleeding, which may include feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain.

Discontinuation of Use Patients should be advised to stop using the product and seek medical advice if any of the following occur:

• Signs of stomach bleeding as previously mentioned

• Any allergic reaction

• Pain that persists for more than 10 days or worsens

• Fever that worsens or lasts longer than three days

• The emergence of new symptoms

• Presence of redness or swelling

• Ringing in the ears or loss of hearing

Emergency Medical Help In the event of an allergic reaction, immediate medical assistance should be sought.

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, there is an allergy alert associated with this product. Aspirin may cause severe allergic reactions, which can manifest as hives, facial swelling, asthma (wheezing), or 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 carries a warning for the potential of 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 blood-thinning medications or steroids, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic drinks daily while using this product, or exceed the recommended dosage or duration of use.

Patients are 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 stomach pain that does not improve. Furthermore, if an allergic reaction occurs, immediate medical assistance is necessary.

Other reasons to discontinue use and seek medical advice include if pain persists for more than 10 days or worsens, if fever worsens or lasts more than three days, if new symptoms develop, if redness or swelling is observed, or if there is ringing in the ears or a loss of hearing.

Drug Interactions

The concomitant use of this product with certain medications may elevate the risk of gastrointestinal bleeding.

Pharmacodynamic Interactions:

• Anticoagulants and Steroids: The use of this product alongside blood-thinning agents (anticoagulants) or steroid medications may significantly increase the risk of stomach bleeding. It is advisable to monitor patients closely for signs of gastrointestinal complications and consider alternative therapies if necessary.

• Nonsteroidal Anti-Inflammatory Drugs (NSAIDs): Co-administration with other NSAIDs, including both prescription and nonprescription options such as aspirin, ibuprofen, and naproxen, may also heighten the risk of stomach bleeding. Patients should be advised to avoid the concurrent use of multiple NSAIDs and to seek medical guidance if they require pain management.

Consultation Recommendations:

Patients taking prescription medications for diabetes, gout, or arthritis should consult their healthcare provider prior to using this product. This is to ensure safe and effective management of their conditions while minimizing the risk of adverse interactions.

Laboratory Test Interactions:

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

Packaging & NDC

Below are the non-prescription pack sizes of Winco Foods Effervescent Pain Relief (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 and monitoring treatment in this population.

For geriatric patients, the recommended dosage is 2 tablets every 4 hours, or as directed by a healthcare provider, with a maximum limit of 4 tablets within a 24-hour period. It is essential for healthcare providers to assess the individual needs and health status of elderly patients to ensure safe and effective use of the medication, while also monitoring for any adverse effects, particularly gastrointestinal complications.

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 fetal development and complications during delivery. Therefore, it is crucial that pregnant patients only use aspirin under the guidance of a healthcare provider if deemed necessary.

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

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

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 substance is known, specific antidotes or treatments may be indicated, and healthcare providers should refer to established guidelines for the management of the particular overdose scenario.

It is vital for healthcare professionals to remain vigilant and act swiftly in the event of an overdose 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 have been identified in the available data. Additionally, there are no details regarding nonclinical toxicology or animal pharmacology and toxicology provided in the text.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as hives, facial swelling, asthma (wheezing), and shock. Additionally, cases of stomach bleeding have been noted, particularly in individuals aged 60 or older, those with a history of stomach ulcers or bleeding problems, patients taking blood-thinning medications, individuals consuming three or more alcoholic drinks daily, or those exceeding the recommended dosage. Symptoms indicative of stomach bleeding may include feeling faint, vomiting blood, having bloody or black stools, and experiencing persistent stomach pain.

New symptoms reported after use include tinnitus (ringing in the ears) and hearing loss. Other concerns involve pain lasting more than 10 days or worsening, as well as fever that worsens or persists for more than three days. The presence of redness or swelling has also been documented. It is advised that individuals seek medical help immediately if any of these symptoms occur.

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 are allergic to aspirin or any other pain reliever or fever reducer, or if they have previously experienced an allergic reaction to this product or any of its ingredients.

Patients should be instructed 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. Additionally, patients should be made aware that they should discontinue use and consult a doctor if they experience any allergic reactions, 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.

It is important for healthcare providers to emphasize that patients should not exceed the recommended dosage while using this product. Patients should also be encouraged to consult a doctor before use if they have a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies to them. Furthermore, patients with high blood pressure, heart disease, liver cirrhosis, or kidney disease should seek medical advice prior to use. Those taking diuretics, individuals with asthma, and patients on a sodium-restricted diet should also consult a doctor before using this product. Lastly, patients should be advised to speak with a doctor or pharmacist if they are taking prescription medications for diabetes, gout, or arthritis.

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 storage conditions are essential to maintain the product's efficacy and safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)