Equaline Effervescent Pain Reliever

Description

Equaline is presented in the media type of image/jpeg. The reference for this product is 42168 EL C5 Equaline Pain 36_APPRVL.jpg.

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, as needed, not to 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, but the total should not exceed 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 adhering 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 may provoke severe allergic reactions in some individuals. Symptoms of such reactions can include hives, facial swelling, asthma (wheezing), and shock. Patients should be instructed to seek immediate medical attention if they experience any signs of an allergic reaction.

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 is increased in patients 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 Patients should be closely monitored for signs of stomach bleeding, which may include feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. If any of these symptoms occur, patients should be advised to discontinue use and seek medical attention.

Additional Precautions Patients should stop using this product and consult a healthcare provider if they experience:

• Pain that persists for more than 10 days or worsens

• Fever that worsens or lasts longer than three days

• New or unexplained symptoms

• Redness or swelling at the site of use

• Ringing in the ears or any loss of hearing

In the event of an allergic reaction, patients must be instructed to seek emergency medical help 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, there is a significant risk of severe allergic reactions to aspirin, which may 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 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, or if new symptoms arise, medical advice should be sought. Patients should also be vigilant for signs of redness or swelling, as well as any ringing in the ears or loss of hearing.

Before using this product, patients should consult a doctor if they have a history of stomach problems, such as heartburn, or if they have high blood pressure, heart disease, liver cirrhosis, or kidney disease. Those taking diuretics, have asthma, or are on a sodium-restricted diet should also seek medical advice prior to use. Additionally, patients taking prescription medications for diabetes, gout, or arthritis should consult a doctor or pharmacist before using this product.

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 for signs of bleeding in patients receiving these combinations.

Additionally, the concomitant use of this product with other nonsteroidal anti-inflammatory drugs (NSAIDs), including prescription and over-the-counter options such as aspirin, ibuprofen, and 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 to mitigate potential adverse effects.

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

Packaging & NDC

Below are the non-prescription pack sizes of Equaline 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 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, with a maximum limit of 4 tablets within a 24-hour period. It is essential for healthcare providers to monitor these patients closely for any signs of gastrointestinal bleeding and to adjust dosages as necessary to mitigate potential risks.

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 or complications during delivery. Therefore, it is crucial that pregnant patients only use aspirin under the guidance of a healthcare provider, particularly in the later stages of pregnancy.

Lactation

Lactating mothers are advised to consult a health professional before using this medication while breastfeeding. It is particularly important to avoid the use of aspirin at 20 weeks of pregnancy or later unless specifically directed by a healthcare provider, 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 in lactating individuals.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

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 management of an overdose may vary depending on the specific substance involved and the severity of the symptoms presented. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Symptoms of overdose can range widely and may include, but are not limited to, severe drowsiness, confusion, respiratory distress, or other significant physiological changes. Continuous monitoring of the patient's vital signs and clinical status is recommended during the management process.

In cases of overdose, supportive care is often necessary, and specific treatment protocols should be followed based on established guidelines and the clinical scenario. It is critical to provide comprehensive care to ensure the safety and well-being of the patient.

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 current information.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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, and to avoid it 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, they should be made aware to seek immediate medical help if an allergic reaction occurs, if pain lasts for more than 10 days or worsens, if fever worsens or lasts more than 3 days, if new symptoms develop, if redness or swelling is present, or if they experience ringing in the ears or a loss of hearing.

It is important to counsel patients not to exceed the recommended dosage while using this product. Providers should also encourage patients to consult 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, if they are taking a diuretic, have asthma, or are on a sodium-restricted diet.

Lastly, patients should be advised to consult a doctor or pharmacist before using this product if they are taking a prescription medication 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 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 Equaline Effervescent Pain Reliever, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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