Redicare Non-Aspirin 500mg

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available data.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including the common cold, headache, backache, minor pain of arthritis, toothache, muscular aches, and premenstrual and menstrual cramps. 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 6 hours as needed for symptom relief. The maximum dosage should not exceed 6 tablets within a 24-hour period, unless otherwise directed by a healthcare professional. Additionally, this medication should not be taken for more than 10 consecutive days unless specifically instructed by a doctor.

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

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, is prohibited due to the risk of acetaminophen overdose. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

• This product should not be used in individuals with a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation, as this may lead to severe allergic reactions.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage under certain conditions. Healthcare professionals should advise patients to avoid exceeding 4,000 mg of acetaminophen within a 24-hour period. Additionally, patients should not use this product concurrently with other medications that contain acetaminophen or consume three or more alcoholic beverages daily while using this product.

Patients with liver disease should consult a healthcare provider prior to use. Furthermore, individuals taking the anticoagulant warfarin should seek guidance from a doctor or pharmacist before using this product, as interactions may occur.

In the event of an overdose, it is imperative to seek emergency medical assistance or contact a Poison Control Center at 1-800-222-1222 immediately. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are initially apparent.

Patients should discontinue use and consult a healthcare professional if any of the following occur: worsening pain that persists beyond 10 days, a fever that worsens or lasts more than 3 days, the emergence of new symptoms, or the presence of redness or swelling, as these may indicate a serious underlying condition.

Side Effects

Patients may experience a range of adverse reactions associated with the use of acetaminophen. Notably, severe skin reactions have been reported, which may manifest as skin reddening, blisters, or rash. In the event of any skin reaction, patients are advised to discontinue use immediately and seek medical assistance.

There is a significant warning regarding the potential for severe liver damage. This risk is heightened if patients exceed a dosage of 4,000 mg of acetaminophen within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while taking this product.

Patients should also be vigilant and consult a healthcare professional if they experience worsening pain that persists beyond 10 days, a fever that worsens or lasts more than three days, the emergence of new symptoms, or the presence of redness or swelling, as these may indicate a serious underlying condition.

Drug Interactions

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking warfarin, a blood-thinning agent. The combination may increase the risk of bleeding due to potential pharmacodynamic interactions.

Additionally, this medication should not be used in conjunction with any other products containing acetaminophen, whether prescription or over-the-counter. Co-administration may lead to an increased risk of acetaminophen-related hepatotoxicity. If there is uncertainty regarding the presence of acetaminophen in other medications, patients are advised to seek guidance from a healthcare provider.

Packaging & NDC

Below are the non-prescription pack sizes of Redicare Non-Aspirin 500mg (redicare non-aspirin, acetaminophen 500mg). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosage is 2 tablets every 6 hours as needed for symptom relief. It is important not to exceed 6 tablets in a 24-hour period unless directed by a healthcare provider. Additionally, treatment should not extend beyond 10 days without medical advice.

Geriatric Use

Elderly patients may not have specific information regarding the use of Redicare Non-Aspirin 500mg, including dosage adjustments, safety concerns, or special precautions. As such, healthcare providers should exercise caution when prescribing this medication to geriatric patients.

Due to the absence of data on the geriatric population, it is advisable for healthcare providers to closely monitor elderly patients for any potential adverse effects or changes in efficacy. Consideration should be given to the overall health status and comorbidities of geriatric patients when determining the appropriateness of this medication.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. 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 administering this medication to 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 should exercise caution when using this product, as it contains acetaminophen, which can lead to severe liver damage under certain conditions. Specifically, patients should not exceed 4,000 mg of acetaminophen in a 24-hour period, nor should they use this product concurrently with other medications that contain acetaminophen. Additionally, consumption of three or more alcoholic drinks daily while using this product may further increase the risk of liver damage.

It is recommended that patients with liver disease consult a healthcare professional prior to using this product to assess the appropriateness of treatment and to discuss potential risks associated with acetaminophen use. Monitoring of liver function may be warranted in these patients to ensure safety and efficacy.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, vigilance and timely action are essential in managing overdose situations effectively.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

Postmarketing experience has revealed that acetaminophen may cause severe skin reactions. Reported symptoms include skin reddening, blisters, and rash. In the event of a skin reaction, users are advised to discontinue use and seek medical assistance immediately.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. Patients should be informed not to use this product in conjunction with any other medications that contain acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in their other medications, they should be encouraged to consult with a doctor or pharmacist.

It is crucial to inform patients not to use this product if they have a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation. Patients should be instructed to discontinue use and seek medical advice if their pain worsens or persists for more than 10 days, if their fever worsens or lasts longer than 3 days, or if they experience any new symptoms. Additionally, patients should be made aware that the presence of redness or swelling may indicate a serious condition, warranting immediate consultation with a healthcare professional.

Patients with a history of liver disease should be advised to consult a doctor before using this medication. Furthermore, those taking the blood-thinning medication warfarin should be encouraged to speak with a doctor or pharmacist prior to use to ensure safety and avoid potential interactions.

Storage and Handling

The product is supplied in a configuration that includes an imprinted safety seal under the cap. It is essential to ensure that this seal is intact before use, as the product should not be utilized if the seal is broken or missing.

For optimal storage, the product must be maintained at a temperature range of 20°-25°C (68°-77°F). Proper adherence to these storage conditions is crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

No additional information is available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

For administration, adults and children aged 12 years and older are advised to take 2 tablets every 6 hours as needed for symptoms, with a maximum of 6 tablets in 24 hours unless otherwise directed by a physician. The use of this medication should not exceed 10 days unless directed by a doctor. For children under 12 years, consultation with a doctor is recommended before use.

Drug Information (PDF)

This file contains official product information for Redicare Non-Aspirin 500mg, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)