Drx Choice

Description

Acetaminophen is presented in a dosage form of 325 mg per tablet, functioning as a pain reliever and fever reducer. The product is packaged in a bottle containing 60 tablets. It is important to note that the product features a tamper-evident seal; it should not be used if the printed inner seal under the cap is broken or missing. This formulation is comparable to the active ingredient found in Tylenol® Regular Strength. It is distributed by Raritan Pharmaceuticals, located at 8 Joanna Court, East Brunswick, NJ 08816. This product is not manufactured or distributed by Kenvue Inc., the owner of the registered trademark Tylenol® Regular Strength.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, muscular aches, backache, minor pain of arthritis, the common cold, toothache, 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 instructed to take 2 tablets every 4 to 6 hours as needed for symptom relief. The maximum dosage should not exceed 10 tablets within a 24-hour period, unless otherwise directed by a healthcare professional. Additionally, this medication should not be used for more than 10 consecutive days without medical advice.

For children aged 6 years to under 12 years, the recommended dosage is 1 tablet every 4 to 6 hours while symptoms persist. The total daily intake must not exceed 5 tablets, and use should be limited to a maximum of 5 days unless directed by a physician.

In the case of children under 6 years of age, it is advised to consult a healthcare provider for appropriate dosing recommendations.

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. If there is uncertainty regarding the presence of acetaminophen in another medication, 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.

Warnings and Precautions

This product contains acetaminophen, which poses significant risks if not used according to the recommended guidelines. The maximum daily dosage for adults is limited to 10 tablets (3,250 mg) within a 24-hour period, while for children, the maximum is 5 tablets (1,625 mg) in the same timeframe. Severe liver damage may occur under the following circumstances:

• An adult consumes more than 4,000 mg of acetaminophen in 24 hours.

• A child exceeds 5 doses in 24 hours, which is the maximum daily allowance.

• The product is taken concurrently with other medications containing acetaminophen.

• An adult consumes 3 or more alcoholic beverages daily while using this product.

Allergy Alert Acetaminophen may induce severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. Should any of these symptoms manifest, the user must discontinue use immediately and seek medical assistance.

General Precautions Healthcare professionals should advise patients to consult a physician prior to use if they have liver disease or if the patient is a child experiencing pain due to arthritis. Additionally, it is prudent to consult a doctor or pharmacist before use if the patient is concurrently taking the anticoagulant warfarin.

Emergency Medical Help In the event of an overdose, immediate medical attention is essential. Users should contact a Poison Control Center at 1-800-222-1222 without delay, as prompt intervention is critical for both adults and children, even in the absence of noticeable symptoms.

Discontinuation and Consultation Patients should cease use and consult a healthcare provider if any of the following occur:

• Pain worsens or persists beyond 10 days in adults.

• Pain worsens or lasts more than 5 days in children under 12 years.

• Fever worsens or lasts more than 3 days.

• New symptoms arise.

• Redness or swelling is observed.

These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the recommended dosage of acetaminophen. Specifically, adults should not take more than 4,000 mg in a 24-hour period, while children should not exceed 5 doses within the same timeframe, which constitutes the maximum daily amount. The risk of liver damage is further heightened if acetaminophen is taken in conjunction with other medications containing acetaminophen or if an adult consumes three or more alcoholic drinks daily while using this product.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen use. Symptoms may include skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Patients are advised not to use this product in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in another medication, consultation with a doctor or pharmacist is recommended. Additionally, individuals with known allergies to acetaminophen or any inactive ingredients in this product should refrain from use.

Patients should stop using the product and consult a doctor if pain worsens or persists for more than 10 days in adults, or if pain lasts more than 5 days in children under 12 years. A fever that worsens or lasts more than 3 days, the emergence of new symptoms, or the presence of redness or swelling may indicate a serious condition, warranting medical evaluation.

It is advisable for patients to consult a doctor prior to use if they have liver disease or if a child is experiencing pain due to arthritis. Furthermore, patients taking the blood-thinning medication warfarin should seek guidance from a doctor or pharmacist before using this product.

Drug Interactions

Patients taking warfarin, a blood-thinning medication, should consult with a healthcare professional prior to using this product. The interaction between this product and warfarin may necessitate careful monitoring of coagulation parameters to ensure patient safety and efficacy of therapy. Adjustments to the dosage of either medication may be required based on clinical judgment and patient response.

Packaging & NDC

Below are the non-prescription pack sizes of Drx Choice (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

The maximum daily dose for pediatric patients is 5 tablets (1,625 mg) within a 24-hour period. For children aged 6 years to under 12 years, the recommended dosage is 1 tablet every 4 to 6 hours as needed, with a strict limit of 5 tablets in 24 hours. Use should not exceed 5 consecutive days unless directed by a healthcare professional.

For children under 6 years of age, it is advised to consult a doctor prior to use. In cases of pain in children under 12 years, if the pain worsens or persists beyond 5 days, the medication should be discontinued, and a doctor should be consulted. Similarly, if a fever in children lasts more than 3 days or worsens, the use of the medication should be stopped, and medical advice should be sought.

An overdose warning is in place, emphasizing the importance of seeking immediate medical attention for children, even if no signs or symptoms of overdose are apparent.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

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 considered in these populations to ensure the safety of both the mother and the fetus or infant.

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 drug insert regarding dosage adjustments, special monitoring, or safety considerations. As such, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, given the absence of detailed guidance on its use in this population. Regular monitoring of renal function may be prudent in these patients, although specific recommendations are not provided.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to using this product. It is important to note that severe liver damage may occur if an adult exceeds a dosage of 4,000 mg of acetaminophen within a 24-hour period. Additionally, patients who consume three or more alcoholic drinks daily while using this product are at an increased risk for severe liver damage. Therefore, careful consideration and monitoring of liver function are advised for patients with compromised liver function to prevent potential adverse effects.

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 management of an overdose may vary depending on the specific substance involved and the clinical presentation of the patient. Continuous monitoring and supportive care may be necessary to address any potential complications that arise from the overdose.

It is essential to gather as much information as possible regarding the substance taken, the amount, and the time of ingestion, as this will aid in the assessment and management of the situation.

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 use of the compound in question.

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions. Reports indicate that symptoms can include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use immediately and seek medical assistance.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is important to inform patients not to use this product in conjunction with any other medications that contain acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult a doctor or pharmacist for clarification.

Patients should be made aware that they must not use this medication if they have a known allergy to acetaminophen or any of the inactive ingredients present in the product. They should be instructed to stop using the medication and seek medical advice if their pain worsens or persists for more than 10 days in adults, or more than 5 days in children under 12 years. Additionally, if a fever worsens or lasts more than 3 days, or if new symptoms arise, patients should be advised to discontinue use and consult a healthcare professional.

It is crucial to inform patients to seek medical attention if they notice any redness or swelling, as these may indicate a serious condition. Patients with liver disease should be advised to consult a doctor before using this medication. Furthermore, if the patient is a child experiencing pain due to arthritis, they should also be encouraged to seek medical advice prior to use. Lastly, patients taking the blood-thinning medication warfarin should be instructed to consult a doctor or pharmacist before using this product.

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 to maintain its integrity and efficacy. Proper handling should be observed to ensure optimal conditions are met throughout the storage period.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Drx Choice, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)