Regular Strength Pain Relief

Description

Acetaminophen 325 mg is presented in a dosage form of liquid gels, with each unit containing 325 mg of the active ingredient. The product is identified by the National Drug Code (NDC) 51013-402-25. 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 aged 12 years and older are advised 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 years to under 12 years, the recommended dosage is 1 softgel every 4 to 6 hours while symptoms last. The total daily intake should not exceed 5 softgels, and usage should not extend beyond 5 days unless instructed by a physician.

In the case of 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 under the following circumstances:

• An adult consumes more than 4,000 mg of acetaminophen in 24 hours.

• A child exceeds 5 doses in 24 hours, which is the maximum daily allowance.

• The product is taken concurrently with other medications containing acetaminophen.

• 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 recommended that patients taking the anticoagulant warfarin seek guidance from a healthcare provider or pharmacist before using this product.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222. Prompt medical attention is crucial for both adults and children, even if no symptoms are initially apparent.

Patients should discontinue use and consult a physician if any of the following occur:

• Pain worsens or persists for more than 10 days in adults.

• Pain worsens or lasts more than 5 days in children under 12 years.

• Fever worsens or lasts more than 3 days.

• New symptoms develop.

• Redness or swelling is observed, as these may indicate a serious 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. Quick medical attention is critical for both adults and children, even if no signs or symptoms are initially apparent.

Drug Interactions

Co-administration of this medication with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose, which can lead to severe liver damage.

Additionally, caution is advised when this medication is used in conjunction with warfarin, a blood-thinning agent. It is recommended that patients consult with a healthcare professional, such as a doctor or pharmacist, prior to using this medication if they are currently taking warfarin. Monitoring of coagulation parameters may be necessary to ensure patient safety and to adjust dosages accordingly.

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 years to under 12 years may take 1 softgel every 4 to 6 hours as needed for symptoms, with a maximum of 5 softgels (1,625 mg) in a 24-hour period. It is advised that this medication not be used for more than 5 consecutive days unless directed by a healthcare professional.

For children under 6 years of age, consultation with a doctor is recommended prior to use. Additionally, pain in pediatric patients under 12 years should not persist for more than 5 days, and fever should not last longer than 3 days.

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 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. 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 medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating mothers.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have liver disease. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the degree of impairment. Careful evaluation of the patient's overall health status is recommended to ensure safe and effective use of the medication.

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 taking more than the advised amount 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 recognize the seriousness of this situation and act promptly.

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 Poison Control Center can be reached at 1-800-222-1222, where trained professionals can provide guidance on the necessary steps to take.

Symptoms and Management It is crucial to note that quick medical attention is essential for both adults and children, even in the absence of observable signs or symptoms of overdose. Early intervention can be critical in mitigating potential harm and ensuring appropriate management of the situation.

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

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 there may be potential interactions.

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 temperature range of 15° to 30°C (59° to 86°F) to maintain its efficacy. Care should be taken to avoid exposure to excessive heat during storage and handling to ensure product integrity.

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)