Regular Strength Pain Reliever

Description

No description information is available for the specified drug.

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 over 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, unless otherwise directed by a healthcare professional. Additionally, this medication should not be used for more than 10 consecutive days without medical supervision.

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 should not exceed 5 tablets, and use should be limited to a maximum of 5 days unless directed by a physician.

For children under 6 years of age, it is essential to consult a healthcare provider for appropriate dosing recommendations.

Contraindications

Use of this product is contraindicated in the following situations:

Patients should not use this product in conjunction with any other drug containing acetaminophen, whether prescription or non-prescription, due to the risk of acetaminophen overdose. Additionally, this product is contraindicated in individuals with a known allergy to acetaminophen or any of the inactive ingredients present in the formulation, as this may lead to severe allergic reactions.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen, under the following circumstances: if an adult consumes more than 4,000 mg of acetaminophen within a 24-hour period; if a child exceeds 5 doses in 24 hours, which is the maximum daily amount; if it is taken concurrently with other medications containing acetaminophen; or if an adult consumes three or more alcoholic drinks daily while using this product.

Acetaminophen is also associated with the potential for severe skin reactions. Symptoms indicative of such reactions 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.

General precautions should be observed prior to use. Individuals with liver disease should consult a healthcare professional before using this product. Additionally, it is advisable for users who are taking the anticoagulant warfarin to seek guidance from a doctor or pharmacist before use.

Users are advised to discontinue use and consult a healthcare provider if any of the following occur: pain worsens or persists for more than 10 days; pain worsens or lasts more than 5 days in children under 12 years; fever worsens or lasts more than 3 days; new symptoms arise; or if redness or swelling is observed, as these may indicate a serious condition.

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, and 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 the 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 and seek medical assistance immediately.

In cases of overdose, patients must obtain medical help or contact a Poison Control Center without delay, as prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Patients are advised to stop use and consult a healthcare professional if any of the following occur: pain worsens or persists for more than 10 days; pain in children under 12 years worsens or lasts more than 5 days; fever worsens or lasts more than 3 days; 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 consult a doctor. Additionally, individuals taking the blood-thinning medication warfarin should seek advice from a doctor or pharmacist prior to use.

Drug Interactions

Acetaminophen may interact with the anticoagulant warfarin, potentially influencing International Normalized Ratio (INR) levels. It is advisable for patients to consult with a healthcare professional, such as a doctor or pharmacist, prior to using acetaminophen if they are concurrently taking warfarin. Monitoring of INR levels may be warranted to ensure therapeutic efficacy and safety.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 6 years to under 12 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. Use should not exceed 5 consecutive days unless directed by a healthcare professional.

For children under 6 years, consultation with a doctor is advised prior to use.

It is important to note that severe liver damage may occur if a child exceeds the maximum recommended dosage of 5 doses in 24 hours. Parents and caregivers should discontinue use and seek medical advice if a child's pain worsens or persists beyond 5 days in those under 12 years of age.

Geriatric Use

Elderly patients should consult a healthcare provider prior to use if they have liver disease, as this may affect the safety and efficacy of the medication. Additionally, it is important for geriatric patients to seek advice from a doctor or pharmacist if they are concurrently taking the anticoagulant warfarin, due to potential interactions that could increase the risk of bleeding.

In the event of an overdose, prompt medical attention is essential for elderly patients, as well as for children, even if no immediate signs or symptoms are apparent. This precaution underscores the importance of monitoring and managing the health of geriatric patients when using this medication.

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 should consider individual circumstances and the specific health needs of the patient when making recommendations.

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 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, which contains acetaminophen. Severe liver damage may occur if the following conditions are met:

• An adult consumes more than 4,000 mg of acetaminophen within a 24-hour period.

• A child exceeds 5 doses in a 24-hour period, which is the maximum daily amount.

• The product is taken concurrently with other medications that contain acetaminophen.

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

Due to the potential for increased risk of liver damage, it is recommended that patients with compromised liver function consult a healthcare professional prior to 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 without delay. Prompt medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Potential Symptoms and Risks An overdose of acetaminophen can lead to severe liver damage, particularly if an adult ingests more than 4,000 mg within a 24-hour period. Healthcare professionals should be vigilant in monitoring for signs of liver impairment, which may not manifest until several hours after ingestion.

Management Procedures Upon recognition of an overdose, healthcare providers should initiate appropriate management protocols. This may include the administration of activated charcoal if the patient presents within a suitable timeframe, as well as the consideration of N-acetylcysteine (NAC) as an antidote to mitigate liver damage. Continuous monitoring of liver function tests and supportive care are essential components of the management strategy.

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

Acetaminophen has been associated with severe skin reactions in postmarketing experience. Reports indicate that symptoms may 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. Patients should be informed not to use this product in conjunction with any other medications that contain acetaminophen, whether prescription or non-prescription. If patients are uncertain whether a medication contains acetaminophen, they should be encouraged to consult with a doctor or pharmacist.

It is essential to inform patients that they should not use this product if they have a known allergy to acetaminophen or any of the inactive ingredients present in the formulation. Patients should be instructed to discontinue use and seek medical advice if they experience worsening pain that lasts more than 10 days, or if pain persists for more than 5 days in children under 12 years. Additionally, they should be advised to seek medical attention if fever worsens or lasts more than 3 days, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious condition.

Patients with liver disease should be encouraged to consult with their healthcare provider before using this medication. Furthermore, it is important for patients to discuss with their doctor or pharmacist if they are currently taking the blood-thinning medication warfarin, as this may require special consideration.

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 a controlled temperature range of 20–25°C (68–77°F) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits to prevent degradation.

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

View product document (PDF)