Regular Strength Pain Relief

Description

Acetaminophen is presented in a dosage form of liquid gels, with each gel containing 325 mg of the active ingredient. The product is identified by the National Drug Code (NDC) 63868-217-20. This formulation is comparable to the active ingredient found in 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 12 years of age and over are instructed to take 2 softgels every 4 to 6 hours as needed while symptoms persist. The maximum allowable dosage is 10 softgels within a 24-hour period. Continuous use should not exceed 10 days unless directed by a healthcare professional.

For children aged 6 to 11 years, the recommended dosage is 1 softgel every 4 to 6 hours while symptoms last. The total daily limit for this age group is 5 softgels, and usage should not extend beyond 5 days unless advised 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, 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.

Additionally, this product is contraindicated 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 liver damage if not used according to the specified guidelines. The maximum daily dosage for adults is limited to 10 softgels (3,250 mg) within a 24-hour period, while for children, the maximum is 5 softgels (1,625 mg) in the same timeframe. Severe liver damage may occur if an adult exceeds 4,000 mg of acetaminophen in 24 hours, if a child takes more than the recommended 5 doses, if the product is used concurrently with other medications containing acetaminophen, or if an adult consumes 3 or more alcoholic beverages daily while using this product.

Healthcare professionals should advise patients to consult a physician prior to use if they have a history of liver disease. Additionally, it is important to seek guidance from a doctor or pharmacist if the patient is currently taking warfarin, a blood-thinning medication, as interactions may occur.

In the event of an overdose, immediate medical assistance is crucial. Patients should be instructed to contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help without delay, regardless of the presence of symptoms.

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

Side Effects

Patients using this product should be aware of the potential for serious adverse reactions, particularly related to liver health. The product contains acetaminophen, and exceeding the maximum daily dose of 10 softgels (3,250 mg) for adults or 5 softgels (1,625 mg) for children may lead to severe liver damage. Specifically, adults should not take more than 4,000 mg of acetaminophen in a 24-hour period, and children should not exceed the maximum daily amount of 5 doses. 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 three or more alcoholic drinks daily while using this product.

Patients are advised not to use this product if they are allergic to acetaminophen or any of the inactive ingredients. Additionally, it is important to consult a healthcare professional before use if the patient has liver disease or is taking the blood-thinning medication warfarin.

Patients should discontinue use and seek medical advice if they experience worsening pain that lasts more than 10 days in adults or more than 5 days in children under 12 years, if fever worsens or persists for more than 3 days, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious condition.

In the event of an overdose, which may occur if the recommended dose is exceeded, patients should seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222). Quick medical attention is crucial for both adults and children, even if no signs or symptoms are immediately apparent.

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. Monitoring for signs of liver damage is advised if acetaminophen is used concurrently.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 6 to 11 years may take 1 softgel every 4 to 6 hours as needed for symptom relief, with a maximum of 5 softgels (1,625 mg) in a 24-hour period. Use 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.

It is important to monitor for pain duration; if pain worsens or persists for more than 5 days in children under 12 years, use should be discontinued and a doctor should be consulted.

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 advisable for geriatric patients to seek guidance 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 that pain worsens or persists for more than 10 days, or if fever intensifies or lasts longer than 3 days, elderly patients are advised to discontinue use and consult a healthcare professional. Prompt medical attention is essential for all adults, including geriatric patients, in cases of suspected overdose. Monitoring and appropriate dose adjustments may be necessary to ensure the safety of elderly patients using this medication.

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 weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

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, which contains acetaminophen. The maximum daily dose for adults is 10 softgels (3,250 mg) within a 24-hour period, while for children, it is limited to 5 softgels (1,625 mg) in the same timeframe. It is critical to note that severe liver damage may occur if an adult exceeds 4,000 mg of acetaminophen in 24 hours, or if a child takes more than the maximum daily amount of 5 doses. Additionally, the risk of liver damage increases if this product is taken concurrently with other medications containing acetaminophen or if an adult consumes 3 or more alcoholic drinks daily while using this product.

Patients with known liver disease should consult a healthcare professional prior to use. It is essential to adhere strictly to the recommended dosing guidelines, as exceeding these may lead to overdose and subsequent liver damage. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay. Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Overdosage

In the event of an overdose, the potential for liver damage increases significantly when the recommended dose is exceeded. It is imperative that healthcare professionals remain vigilant regarding the signs and symptoms of overdose, as these may not always be immediately apparent.

Recommended Actions In cases of suspected overdose, immediate medical assistance should be sought. Healthcare providers are advised to contact a Poison Control Center without delay. The national helpline for poison control can be reached at 1-800-222-1222. Prompt intervention is crucial, as timely medical attention can mitigate the risk of severe complications.

Management Procedures Both adults and children require swift medical evaluation following an overdose, regardless of the presence of symptoms. It is essential to monitor the patient closely and initiate appropriate management protocols as dictated by clinical guidelines and the specific circumstances of the 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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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 about the presence of acetaminophen in other medications, they should be encouraged to consult with a doctor or pharmacist.

Patients should be cautioned against using this product if they have a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation. Healthcare providers should instruct patients to discontinue use and seek medical advice if any of the following occur: if pain worsens or persists for more than 10 days in adults, if pain worsens or lasts more than 5 days in children under 12 years, if fever worsens or lasts more than 3 days, if new symptoms arise, or if there is any redness or swelling. These symptoms may indicate a serious condition that requires further evaluation.

Additionally, healthcare providers should recommend that patients consult with a doctor prior to using this medication if they have liver disease. It is also advisable for patients to speak with a doctor or pharmacist before use if they are currently taking the blood-thinning medication warfarin, as interactions may occur.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at room temperature, within the range of 15° to 30°C (59° to 86°F). Care should be taken to ensure that the product is kept in a suitable container to maintain its integrity. Special handling requirements should be observed to prevent exposure to extreme temperatures or conditions that may compromise the product's quality.

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 additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)