Drug Mart Effervescent Pain Relief

Description

Drug Mart Pain 36 is a pharmaceutical formulation designed for the management of pain. The specific chemical composition and molecular weight are proprietary. The dosage form is a tablet, which is intended for oral administration. The appearance of the tablet is consistent with standard pharmaceutical practices, ensuring ease of identification and use in clinical settings. Inactive ingredients are included to facilitate the formulation's stability and bioavailability, although specific details regarding these components are not disclosed.

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, or as directed by a healthcare professional. The maximum allowable dosage for this age group is eight tablets within a 24-hour period. For individuals aged 60 years and older, the dosage remains two tablets every four hours, 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 recommendations.

To prepare the medication, place two 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

Patients should be advised of the following warnings and precautions associated with the use of this product.

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 cause severe allergic reactions. Symptoms may include hives, facial swelling, asthma (wheezing), and shock. Immediate medical attention should be sought if any signs of an allergic reaction occur.

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 taking anticoagulants or steroid medications

• Are using other NSAIDs, whether prescription or over-the-counter (such as aspirin, ibuprofen, or 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, having bloody or black stools, or experiencing persistent stomach pain. If any of these symptoms occur, the patient should discontinue use and seek medical advice immediately.

Additional Precautions Patients should also be advised to stop using the product and consult a healthcare professional if:

• Pain persists for more than 10 days or worsens

• Fever worsens or lasts longer than three days

• New symptoms develop

• Redness or swelling is observed

• Ringing in the ears or hearing loss occurs

In the event of an allergic reaction or any severe adverse effects, emergency medical assistance should be obtained without delay.

Side Effects

Patients using this product should be aware of several serious adverse reactions associated with its use. Reye’s syndrome is a rare but serious illness that may 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 symptoms could indicate the onset 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.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may increase the risk of severe stomach bleeding. The likelihood 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 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 stomach pain that does not improve. Furthermore, if an allergic reaction occurs, medical assistance should be sought immediately. Other reasons to stop use and consult a doctor include persistent pain lasting more than 10 days, worsening fever lasting more than three days, the emergence of new symptoms, the presence of redness or swelling, or symptoms such as ringing in the ears or loss of hearing.

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 for signs of bleeding in patients receiving such combinations.

Additionally, the use of this product alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin, ibuprofen, and naproxen, may similarly increase the risk of stomach bleeding. It is advisable to evaluate the necessity of NSAID therapy in patients using this product and to monitor for gastrointestinal 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 Drug Mart 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 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 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. It is particularly important to avoid the use of aspirin at 20 weeks of pregnancy 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 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 are no 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 necessary to counteract the effects of the overdose.

It is essential for healthcare providers to remain vigilant and act swiftly to ensure the safety and well-being of the patient in the event of an overdose.

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

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, 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, they should seek immediate medical help if an allergic reaction occurs, if pain persists 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 observed, or if they experience ringing in the ears or a loss of hearing.

When using this product, patients should be cautioned not to exceed the recommended dosage. Healthcare providers should encourage patients 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. It is also important to advise patients to seek medical advice if they have high blood pressure, heart disease, liver cirrhosis, or kidney disease, or if they are taking a diuretic. Patients with asthma or those on a sodium-restricted diet should also consult a doctor before use. Furthermore, patients should be encouraged 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 is essential to store the product at room temperature, maintaining a range of 59ºF to 86ºF. Care should be taken to avoid exposure to excessive heat, as this may compromise the integrity of the product. Proper storage conditions are crucial to ensure the product remains effective and safe for use.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)