Pain Reliever

Description

SELECT™ is a pain reliever formulated with extra strength acetaminophen, delivering 1,000 mg per 30 mL dosage. This product is indicated for the relief of pain and reduction of fever. It features a cherry flavor and is free from dyes and aspirin. SELECT™ is suitable for individuals aged 12 years and older. The product is packaged in an 8 FL OZ (237 mL) container, which includes a tamper-evident warning stating: "TAMPER EVIDENT: DO NOT USE IF PRINTED NECK WRAP IS BROKEN OR MISSING." It is distributed by Better Living Brands LLC, located at P.O. Box 99, Pleasanton, CA 94566-0009. For customer inquiries, a service line is available at 1-888-723-3929. The National Drug Code (NDC) for this product is 21130-945-19.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscular aches, toothache, backache, minor pain from arthritis, the common cold, premenstrual and menstrual cramps, and headache. 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 30 mL every 6 hours as needed while symptoms persist. It is imperative that they do not exceed a total of 90 mL within a 24-hour period unless specifically directed by a healthcare professional. Additionally, the duration of use should not exceed 10 days unless advised by a doctor.

For accurate dosing, it is essential to utilize only the dose cup provided with the medication.

Children under 12 years of age should not use this medication.

Contraindications

Use of this product is contraindicated in patients who are concurrently taking any other medication that contains acetaminophen, whether prescription or nonprescription. This precaution is necessary to avoid the risk of acetaminophen overdose, which can lead to serious liver damage. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients that the risk of liver injury increases significantly if they exceed 4,000 mg of acetaminophen within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic beverages daily while taking this product.

Patients should be informed of the potential for severe skin reactions associated with acetaminophen. Symptoms may include blisters, rash, and skin reddening. In the event of any skin reaction, patients must discontinue use immediately and seek medical assistance.

It is essential for patients to consult a healthcare provider prior to using this product if they have a history of liver disease. Additionally, patients taking the anticoagulant warfarin should seek advice from a doctor or pharmacist before use, as there may be interactions that require monitoring.

In cases of overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center or seek emergency medical help without delay, regardless of whether symptoms are present, as prompt intervention is vital for both adults and children.

Patients should also be advised to discontinue use and consult a healthcare professional if any of the following occur: pain worsens or persists for more than 10 days, fever intensifies or lasts longer than 3 days, new symptoms develop, or if there is any redness or swelling.

Side Effects

Patients using this product should be aware of potential adverse reactions associated with its use.

Severe liver damage may occur if patients exceed 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 using this product.

Additionally, there is an allergy alert associated with acetaminophen, which may lead to severe skin reactions. Symptoms of such reactions can include blisters, rash, and skin reddening. If any skin reaction occurs, patients are advised to discontinue use immediately and seek medical assistance.

Patients should stop using the product and consult a healthcare professional if pain worsens or persists for more than 10 days, if fever worsens or lasts longer than 3 days, if any new symptoms appear, or if there is any redness or swelling.

It is recommended that patients with liver disease consult a doctor before using this product. Furthermore, individuals taking the blood-thinning medication warfarin should seek advice from a doctor or pharmacist prior to use.

Drug Interactions

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

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For patients aged 12 years and older, the recommended dosage is 30 mL every 6 hours as needed while symptoms persist. It is important not to exceed 90 mL in a 24-hour period unless directed by a healthcare professional. Additionally, the medication should not be used for more than 10 days unless advised by a doctor.

In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center without delay. Prompt medical attention is essential for both adults and pediatric patients, even if no signs or symptoms of overdose are apparent.

Geriatric Use

There is no specific information available 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to evaluate the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare providers should consider the available data and individual patient circumstances when advising on the use of this medication in these populations.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this drug in human 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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical for patients to adhere to the following guidelines to minimize the risk of hepatotoxicity:

• Patients should not exceed a maximum dosage of 4,000 mg of acetaminophen within a 24-hour period.

• Concurrent use with other medications containing acetaminophen is contraindicated, as this may lead to unintentional overdose and increased risk of liver injury.

• Consumption of three or more alcoholic drinks daily while using this product is not recommended, as it may exacerbate the risk of liver damage.

Additionally, patients with a history of liver disease are advised to consult a healthcare professional prior to using this product to ensure safe and appropriate use. Regular monitoring of liver function may be warranted in patients with compromised liver function to detect any potential adverse effects promptly.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. 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, it is essential to monitor the patient closely and provide appropriate care as needed.

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 identified that acetaminophen may be associated with severe skin reactions. Reports indicate that symptoms can include blisters, rash, and skin reddening. 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 seek immediate medical assistance or contact a Poison Control Center in the event of an overdose, emphasizing that prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Patients should be informed not to use this medication in conjunction with any other drug that contains acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in their medications, they should be encouraged to consult with a doctor or pharmacist for clarification.

Healthcare providers should instruct patients to discontinue use and consult a doctor if their pain worsens or persists for more than 10 days. Similarly, patients should be advised to stop using the medication and seek medical advice if their fever worsens or lasts longer than 3 days. They should also be informed to stop use and consult a doctor if any new symptoms arise, or if they notice redness or swelling.

It is important for healthcare providers to recommend that patients with liver disease consult a doctor before using this medication. Additionally, patients taking the blood-thinning medication warfarin should be advised 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 packaging that includes specific NDC numbers. It should be stored at a controlled room temperature of 25°C (77°F). Temporary excursions are permitted within the range of 15°C to 30°C (59°F to 86°F). It is essential to adhere to the expiration date indicated on the package to ensure product efficacy and safety.

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 Pain Reliever, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)