Pain Reliever

Description

Acetaminophen is formulated as a liquid dosage form containing 500 mg of acetaminophen per 15 mL. It serves as a pain reliever and fever reducer, indicated for individuals aged 12 years and older. The product is presented in a cherry flavor. It is tamper evident, and users are advised not to use the product if the printed safety seal around the dosage cup or under the cap is broken or missing. This formulation is distributed by Walgreen Co., located at 200 Wilmot Rd., Deerfield, IL 60015. It is important to note that this product is not manufactured or distributed by Johnson & Johnson, the owner of the registered trademark Tylenol®. For additional information, visit walgreens.com.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with the following conditions: 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

Patients should adhere strictly to the recommended dosage and administration guidelines to ensure safety and efficacy.

For adults and children aged 12 years and older, the recommended dosage is 30 mL every 6 hours as needed for symptom relief. It is imperative that no more than 4 doses are taken within a 24-hour period. Additionally, treatment should not exceed 10 days unless directed by a healthcare professional.

For accurate dosing, the provided dosing cup must be used; no other dosing devices should be employed. The dosing cup should be kept with the product to ensure proper measurement.

Children under 12 years of age should not use this product. It is essential to follow these guidelines to avoid the risk of overdose and to ensure optimal therapeutic outcomes.

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 carries a significant risk of severe liver damage if not used according to the guidelines. Healthcare professionals should advise patients that the risk of liver damage increases with the following conditions: exceeding 4,000 mg of acetaminophen within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of three or more alcoholic beverages daily while using this product.

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

General precautions should be taken into account. Patients with a history of liver disease should consult a healthcare provider prior to use. Additionally, individuals taking the anticoagulant warfarin should seek advice from a doctor or pharmacist before using this product, as interactions may occur.

In cases of overdose, it is imperative to seek emergency medical help or contact a Poison Control Center (1-800-222-1222) without delay. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are immediately apparent.

Patients should be instructed to stop taking the product 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 redness or swelling is observed. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

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

Severe liver damage may occur if patients exceed 4,000 mg of acetaminophen in a 24-hour period, use this product in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product. In cases of overdose, which may result from taking more than the recommended dose, immediate medical attention is critical. Patients are advised to contact a Poison Control Center (1-800-222-1222) without delay, even if no signs or symptoms are present.

Additionally, acetaminophen may cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. Should any skin reaction occur, patients must discontinue use and seek medical assistance promptly.

Patients should not use this product if they are allergic to acetaminophen or any of the inactive ingredients. It is also contraindicated for use with any other drug containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, patients should consult a healthcare professional.

Patients are advised to stop using the product and consult a doctor if pain worsens or persists for more than 10 days, if fever worsens or lasts longer than 3 days, if new symptoms arise, or if redness or swelling is observed, as these may indicate a serious condition.

Before using this product, patients with liver disease should seek medical advice. Furthermore, those taking the blood-thinning medication warfarin should consult a doctor or pharmacist prior to use.

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 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 adolescents aged 12 years and older, the recommended dosage is 30 mL every 6 hours as needed while symptoms persist. It is important to note that the medication should not be taken for more than 10 days unless directed by a healthcare professional.

In the event of an overdose, prompt medical attention is essential for pediatric patients, even if no signs or symptoms are immediately apparent.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, 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 assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

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 medication 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 not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should be aware that this product contains acetaminophen, which carries a risk of severe liver damage. It is crucial for these patients to adhere to the following guidelines to minimize the risk of liver injury:

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

• Caution is advised when using this product in conjunction with other medications that contain acetaminophen, as this may increase the risk of overdose and subsequent liver damage.

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

Before using this product, patients with liver disease should consult a healthcare professional to assess the appropriateness of use.

In the event of an overdose, which may occur if the recommended dose is exceeded, patients must seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt medical attention is essential for both adults and children, even if no signs or symptoms of overdose are present.

Overdosage

Taking more than the recommended dose of this medication may lead to significant liver damage. It is imperative that healthcare professionals remain vigilant regarding the potential for overdose and its serious consequences.

In the event of an overdose, immediate medical assistance should be sought. Healthcare providers are advised to contact a Poison Control Center at 1-800-222-1222 without delay. Quick intervention is crucial, as the risk of liver damage can escalate rapidly.

It is important to note that prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms of overdose. Early recognition and management can significantly improve outcomes in cases of suspected overdose.

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

Severe skin reactions have been reported in postmarketing experience with acetaminophen, including symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

Additionally, cases of overdose have been documented, which may lead to liver damage. It is crucial for individuals who suspect an overdose to obtain medical help or contact a Poison Control Center (1-800-222-1222) without delay. Prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Patient Counseling

Healthcare providers should advise patients about the potential risks associated with overdose, emphasizing that taking more than the recommended dose may lead to liver damage. In the event of an overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Patients must be cautioned against using this medication in conjunction with any other products containing acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in other medications, they should be encouraged to consult with a doctor or pharmacist.

It is essential to inform patients that they should not use this medication if they have a known allergy to acetaminophen or any of the inactive ingredients included in the product.

Patients should be instructed to discontinue use and consult a doctor if their pain worsens or persists for more than 10 days, if their fever intensifies or lasts longer than 3 days, if they experience new symptoms, or if they notice any redness or swelling, as these may indicate a serious condition.

Additionally, healthcare providers should recommend that patients seek medical advice before using this medication if they have liver disease. Patients taking the blood-thinning medication warfarin should also be advised to consult with a doctor or pharmacist prior to use.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. It should be stored at a temperature range of 20-25ºC (68-77ºF) and must not be refrigerated. Additionally, it is essential to protect the product from light to maintain its integrity and effectiveness.

Additional Clinical Information

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

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)