Cvs Effervescent Pain Reliever

Description

CVS Health Pain 36 is a pharmaceutical product formulated for the management of pain. The specific chemical composition and molecular weight are not provided. The dosage form and appearance details are also not specified. Further information regarding inactive ingredients and additional characteristics may be necessary for a comprehensive understanding of the product's formulation and intended use.

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, consultation with a healthcare provider is required prior to administration.

To prepare the medication, place 2 tablets in 4 fluid ounces of water. It is essential to completely dissolve the tablets before consumption. The solution 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 ingested, as the active medication is contained within the dissolved solution. Healthcare professionals should ensure that patients are aware of these instructions to avoid serious injury and to adhere to the recommended dosages.

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

In the event of an allergic reaction, immediate medical assistance is essential.

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 may increase the risk of severe stomach bleeding. This risk 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 pain persists for more than 10 days or worsens, if fever worsens or lasts more than three days, if new symptoms arise, if redness or swelling is present, or if there is ringing in the ears or a loss of hearing, medical advice should be sought.

Drug Interactions

The concomitant use of this product with anticoagulants or steroid medications may elevate the risk of gastrointestinal bleeding. Healthcare professionals should exercise caution and consider monitoring patients for signs of bleeding when these medications are used together.

Additionally, the use of this product alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including but not limited to aspirin, ibuprofen, and naproxen, may also increase the risk of stomach bleeding. It is advisable to assess the necessity of concurrent NSAID therapy and to monitor for gastrointestinal adverse effects.

Patients who are prescribed medications for diabetes, gout, or arthritis should consult their healthcare provider prior to using this product to ensure safe and effective use, as potential interactions may necessitate dosage adjustments or increased monitoring.

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

Packaging & NDC

Below are the non-prescription pack sizes of Cvs Effervescent Pain Reliever (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, 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 in a 24-hour period. It is essential for healthcare providers to assess the individual needs of elderly patients and to monitor for any adverse effects, particularly gastrointestinal complications, during treatment.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to use. The use of aspirin is particularly cautioned against after 20 weeks of pregnancy, as it may pose risks to the developing fetus and lead to complications during delivery. It is essential for healthcare providers to evaluate the necessity of aspirin in these circumstances and to consider alternative treatments when appropriate.

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, 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 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 relation to the use of this medication. Consequently, there is no information available 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.

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 in monitoring for symptoms that may arise from an overdose. While specific symptoms are not detailed in the provided information, it is essential to assess the patient for any signs of toxicity or distress.

Management of an overdose should be guided by the severity of the symptoms and the clinical judgment of the healthcare provider. Supportive care and symptomatic treatment may be necessary, and the involvement of poison control experts can provide additional guidance on the appropriate management strategies.

In summary, timely medical intervention and thorough assessment are critical components in the management of overdose cases.

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 provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has indicated that aspirin may lead to severe allergic reactions, which can manifest as hives, facial swelling, asthma (wheezing), and shock. Additionally, there have been reports of gastrointestinal bleeding associated with aspirin use, particularly among older patients, those with a history of stomach ulcers or bleeding disorders, and individuals taking other medications that heighten the risk of bleeding. Adverse reactions documented in postmarketing surveillance include gastrointestinal bleeding, allergic reactions, and other serious side effects.

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 ever had 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, they should be aware that an allergic reaction may occur, and if this happens, they should seek medical help immediately. Patients should also be advised to consult a healthcare provider if pain lasts for more than 10 days or worsens, if fever worsens or lasts more than 3 days, if new symptoms arise, if redness or swelling is present, or if they experience ringing in the ears or a loss of hearing.

When using this product, patients must not exceed the recommended dosage. Healthcare providers should encourage patients to ask a doctor before use if the stomach bleeding warning applies to them, if they have a history of stomach problems (such as heartburn), high blood pressure, heart disease, liver cirrhosis, or kidney disease. Patients should also be advised to consult a healthcare provider if they are taking a diuretic, have asthma, or are on a sodium-restricted diet.

Furthermore, patients should be encouraged to speak with a doctor or pharmacist before using this product if they are taking a prescription drug 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, as this 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 Cvs Effervescent Pain Reliever, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)