Family Wellness Pain Reliever

Description

Family Wellness Pain 36 is a proprietary formulation designed for pain relief. The product is presented in a dosage form suitable for oral administration. Specific details regarding its molecular weight, chemical formula, and inactive ingredients are not provided. The formulation is intended for use in managing various types of pain, contributing to overall wellness.

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 ounces of water and ensure that the tablets are completely dissolved before consumption. It is important to note that any residue remaining at the bottom of the glass does not need to be ingested, as the active ingredients are fully contained in the dissolved solution.

This 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 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 be aware of to ensure patient safety.

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, it is imperative to consult a physician, 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. Healthcare providers should be vigilant in assessing patients for any signs of an allergic response.

Stomach Bleeding Warning This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may increase the risk of severe stomach bleeding. The risk is heightened in patients 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 (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, having bloody or black stools, or experiencing persistent stomach pain. Immediate medical attention should be sought if any of these symptoms occur.

Discontinuation of Use Patients should be advised to stop using this product and consult a healthcare provider if they experience any of the following:

• Signs of stomach bleeding as previously mentioned

• Any allergic reaction, which requires urgent medical assistance

• 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

These precautions are essential for the safe use of this product and should be communicated clearly to patients.

Side Effects

Patients using this product should be aware of several serious and common 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.

Aspirin, the active ingredient in this product, may cause 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.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may increase the risk of severe stomach bleeding. The risk 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, or use other NSAIDs concurrently. Patients should be vigilant 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, patients should stop using the product and consult a doctor.

Additional adverse reactions may include prolonged pain lasting more than 10 days, worsening fever lasting more than three days, the emergence of new symptoms, redness or swelling, and tinnitus or hearing loss. Patients are advised to seek medical attention if they experience any of these symptoms.

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. It is also important to inform healthcare providers if they are taking diuretics, have asthma, or are on a sodium-restricted diet. Furthermore, patients should ask a doctor or pharmacist before use if they are taking prescription medications for diabetes, gout, or arthritis.

Drug Interactions

The product contains a nonsteroidal anti-inflammatory drug (NSAID), which is associated with an increased risk of severe gastrointestinal bleeding, particularly in patients concurrently using anticoagulants or corticosteroids. It is advisable for patients to consult a healthcare professional prior to using this product if they are currently prescribed medications for diabetes, gout, or arthritis.

Concomitant use of this product with other NSAIDs, whether prescription or over-the-counter, such as aspirin, ibuprofen, or naproxen, is contraindicated. Patients should be advised to avoid such combinations to mitigate the risk of 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 Family Wellness 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 fetal outcomes or complications during delivery. Therefore, it is crucial that pregnant patients only use aspirin under the guidance of a qualified healthcare provider if deemed necessary.

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 provided 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

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 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 the Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with overdosage.

Healthcare professionals should be aware that the symptoms of 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 specific antidotes are available, their administration should be considered based on the clinical scenario and the substance involved.

It is essential for healthcare providers to remain vigilant and prepared to implement emergency protocols in the event of an overdose, ensuring the best possible outcomes for affected individuals.

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 have a known allergy to aspirin or any other pain reliever or fever reducer. It is crucial to emphasize that individuals who have previously experienced an allergic reaction to this product or any of its ingredients should also refrain from use.

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 persistent stomach pain. Additionally, they should be made aware that an allergic reaction may occur, and they should seek immediate medical help if pain lasts for more than 10 days, worsens, if fever intensifies or lasts more than 3 days, if new symptoms arise, or if there is any redness or swelling. Patients should also be informed to report any ringing in the ears or loss of hearing.

When using this product, patients must not exceed the recommended dosage. It is advisable for patients to consult with a healthcare provider before use 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. Patients taking diuretics, those with asthma, or individuals on a sodium-restricted diet should also seek medical advice prior to use.

Furthermore, patients should be encouraged to consult with a doctor or pharmacist before using this product if they are currently 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 Family Wellness Pain Reliever, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)