Pain Relief

Description

Acetaminophen is the active ingredient in this formulation, with a strength of 325 mg per tablet. The dosage form is tablets, packaged in a size of 100 tablets. This product serves as a pain reliever and fever reducer, and it is comparable to the active ingredient found in Regular Strength Tylenol®. The distributor of this product is Rite Aid, located at 30 Hunter Lane, Camp Hill, PA 17011. For additional information, the website is www.riteaid.com. A tamper evident warning is included, stating that the product should not be used if the imprinted safety seal under the cap is broken or missing.

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 4 to 6 hours as needed for symptom relief. The maximum dosage should not exceed 10 tablets within a 24-hour period. Treatment duration should not exceed 10 days unless directed by a healthcare professional.

For children aged 6 to 11 years, the recommended dosage is 1 tablet every 4 to 6 hours while symptoms persist. The total daily intake should not surpass 5 tablets, and treatment should not continue for more than 5 days unless instructed by a physician.

For children under 6 years of age, it is recommended to consult a doctor for appropriate dosing guidance.

Contraindications

Use of this product is contraindicated in the following situations:

Patients should not use this product in conjunction with any other medication containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

Additionally, this product is contraindicated in individuals with a known allergy to acetaminophen or any of the inactive ingredients contained in this formulation.

Warnings and Precautions

This product contains acetaminophen, which poses a significant risk of severe liver damage under certain conditions. Healthcare professionals should be aware that the risk increases if an adult consumes more than 4,000 mg of acetaminophen within a 24-hour period, or if a child exceeds 5 doses in the same timeframe. Additionally, the risk is heightened when acetaminophen is taken concurrently with other medications containing the same active ingredient or if an adult consumes three or more alcoholic beverages daily while using this product.

Acetaminophen may also trigger severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of any skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare providers should advise patients to consult a physician prior to using this product if they have a history of liver disease. Furthermore, it is recommended that patients taking the anticoagulant warfarin consult with a doctor or pharmacist before use, as potential interactions may occur.

In cases of accidental 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 the presence of symptoms.

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 in adults; redness or swelling is observed; pain lasts more than 5 days in children under 12 years; new symptoms arise; or fever worsens or persists for more than 3 days. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed the recommended dosage. Specifically, adults should not take more than 4,000 mg of acetaminophen in a 24-hour period, and children should not take more than 5 doses within the same timeframe. The risk of liver damage is further increased if the product is taken in conjunction with other medications containing acetaminophen or if the adult consumes 3 or more alcoholic drinks daily while using this product.

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

This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Patients who are unsure if a drug contains acetaminophen should consult a doctor or pharmacist. Additionally, individuals with a known allergy to acetaminophen or any of the inactive ingredients in this product should avoid its use.

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

Patients are advised to discontinue use and consult a doctor if any of the following occur: pain worsens or persists for more than 10 days in adults; redness or swelling is present; pain worsens or lasts more than 5 days in children under 12 years; new symptoms arise; or fever worsens or lasts more than 3 days. These symptoms 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. The risk of acetaminophen overdose and associated hepatotoxicity is heightened when multiple sources of acetaminophen are used simultaneously. If there is uncertainty regarding the presence of acetaminophen in other medications, it is advisable to seek guidance from a healthcare provider.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 6 to 11 years may take 1 tablet every 4 to 6 hours as needed for symptom relief, with a maximum of 5 tablets in a 24-hour period. Treatment should not exceed 5 consecutive days unless directed by a healthcare professional. For children under 6 years of age, consultation with a doctor is advised prior to use.

Healthcare providers should be aware of specific warnings for pediatric patients. If pain worsens or persists for more than 5 days, if new symptoms develop, or if fever worsens or lasts more than 3 days in children under 12 years, these may indicate a serious condition requiring medical evaluation. Additionally, caution is advised regarding liver health; exceeding 5 doses in a 24-hour period may pose a risk of liver damage.

Geriatric Use

Elderly patients should consult a healthcare provider prior to use if they have a history of liver disease. It is important for geriatric patients to be monitored closely for any worsening of pain or if symptoms persist beyond 10 days, at which point they should discontinue use and seek medical advice.

Additionally, pregnant or breastfeeding elderly patients are advised to consult a health professional before using this medication. In the event of an accidental overdose, immediate medical assistance should be sought, and contacting a Poison Control Center is recommended. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms of overdose are apparent.

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 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 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 exercise caution when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical that patients do not exceed the maximum recommended dosage of 4,000 mg of acetaminophen in a 24-hour period for adults, or more than 5 doses in 24 hours for children. Additionally, patients should be aware that taking this product in conjunction with other medications containing acetaminophen may increase the risk of liver damage.

Patients with a history of liver disease are advised to consult a healthcare professional prior to using this product. Furthermore, individuals who consume three or more alcoholic drinks daily should refrain from using this product, as this may further elevate the risk of liver injury. Regular monitoring of liver function may be warranted in patients with compromised liver function to ensure safety and efficacy.

Overdosage

In the event of an accidental overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt medical attention 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 adverse effects. Therefore, vigilance and timely intervention 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 use of the compound in these contexts.

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 about the importance of seeking immediate medical assistance in the event of an accidental overdose. Patients should be informed to contact a Poison Control Center or seek medical help right away, as prompt medical attention is critical for both adults and children. It is essential to emphasize that even if no signs or symptoms are apparent, medical evaluation is necessary to ensure safety and appropriate care.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a controlled room temperature of 25°C (77°F), with permissible excursions between 15°C and 30°C (59°F to 86°F).

Healthcare professionals are advised to check the end flap of the packaging for the expiration date and lot number to ensure proper inventory management and product 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. In the event of an accidental overdose, it is crucial for patients to seek medical assistance or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

Drug Information (PDF)

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

View product document (PDF)