Acetaminophen Regular Strength

Description

Kroger® Regular Strength Acetaminophen Tablets are formulated to provide effective pain relief and fever reduction. Each tablet contains 325 mg of acetaminophen, and the product is available in a bottle containing 100 tablets. The National Drug Code (NDC) for this formulation is 30142-052-21.

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 tablets every 4 to 6 hours as needed while symptoms persist. The maximum allowable dosage is 10 tablets within a 24-hour period, unless otherwise directed by a physician. Continuous use should not exceed 10 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 last. The total daily intake should not exceed 5 tablets, and usage should not extend beyond 5 days unless directed by a healthcare professional.

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

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 necessitates careful monitoring due to the potential for severe liver damage. The maximum daily dosage for adults is limited to 10 tablets (3,250 mg) within a 24-hour period, while for children, the maximum is 5 tablets (1,625 mg) in the same timeframe. It is critical to avoid exceeding 4,000 mg of acetaminophen in 24 hours for adults and 5 doses for children. Additionally, caution is advised when this product is used in conjunction with other medications containing acetaminophen. Consumption of 3 or more alcoholic drinks daily while using this product may further increase the risk of liver damage.

Healthcare professionals should be vigilant for signs of severe skin reactions associated with acetaminophen use. Symptoms may include skin reddening, blisters, or rash. Should any of these reactions occur, it is imperative to discontinue use immediately and seek medical assistance.

In the event of an overdose, prompt medical intervention is essential. Patients or caregivers should 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 be advised to discontinue use and consult a healthcare provider if any of the following occur: pain worsens or persists beyond 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 redness or swelling is observed. These may indicate a serious underlying condition that requires further evaluation.

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 an 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.

Participants in clinical trials and postmarketing experiences indicate that patients should stop using acetaminophen and consult a healthcare professional if pain worsens or persists beyond 10 days in adults, or if pain lasts more than 5 days in children under 12 years. Additionally, if fever worsens or lasts more than 3 days, or if new symptoms arise, medical advice should be sought. The presence of redness or swelling may also indicate a serious condition requiring attention.

Patients with liver disease should consult a doctor before using this product. Furthermore, individuals taking the blood-thinning medication warfarin are advised to seek guidance from 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, it is advisable to seek guidance from a healthcare provider.

Packaging & NDC

Below are the non-prescription pack sizes of Acetaminophen Regular Strength (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 symptoms, with a maximum of 5 tablets (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, it is advised to consult a doctor prior to use.

In pediatric patients, if pain worsens or persists for more than 5 days, or if fever worsens or lasts longer than 3 days, the use of this medication should be discontinued, and a healthcare provider 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 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 crucial for elderly patients, as well as for children, even if no immediate signs or symptoms are observed. This underscores the importance of careful monitoring and adherence to recommended dosages in 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 individuals.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. The maximum daily dose for adults is limited to 10 tablets (3,250 mg) within a 24-hour period, while for children, the maximum is 5 tablets (1,625 mg) in the same timeframe.

Severe liver damage may occur if the following conditions are met: an adult consumes more than 4,000 mg of acetaminophen in a 24-hour period, a child exceeds 5 doses in 24 hours, the product is taken concurrently with other medications containing acetaminophen, or an adult consumes 3 or more alcoholic drinks daily while using this product.

Due to the potential for increased risk of liver toxicity, it is recommended that patients with compromised liver function adhere strictly to the prescribed dosage and be monitored for any signs of liver damage. Regular assessment of liver function may be warranted in these patients to ensure safety and efficacy.

Overdosage

In cases of overdosage, it is critical to recognize the potential for severe liver damage associated with excessive intake of this product. The maximum recommended daily dosage is 10 tablets (3,250 mg) for adults and 5 tablets (1,625 mg) for children within a 24-hour period.

Risk of Liver Damage

Severe liver damage may occur under several circumstances:

• An adult consuming more than 4,000 mg of acetaminophen within 24 hours is at significant risk.

• For children, exceeding 5 doses in a 24-hour period, which constitutes the maximum daily allowance, can lead to similar risks.

• Concurrent use of this product with other medications containing acetaminophen can exacerbate the risk of liver damage.

• Additionally, adults who consume three or more alcoholic beverages daily while using this product may also face an increased risk of severe liver injury.

Recommended Actions

In the event of suspected overdosage, immediate medical attention is essential. Healthcare professionals should assess the patient's condition and consider the administration of activated charcoal if the ingestion occurred within a suitable timeframe. Monitoring liver function tests and providing supportive care are critical components of management. In cases of confirmed acetaminophen overdose, the use of N-acetylcysteine as an antidote should be initiated as per established protocols.

Prompt recognition and intervention are vital to mitigate the risks associated with overdosage of this product.

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 on the importance of seeking immediate medical assistance in the event of an overdose. Patients should be informed to contact a Poison Control Center at 1-800-222-1222 without delay.

It is crucial for patients to understand that quick medical attention is essential for both adults and children, even if they do not exhibit any noticeable signs or symptoms of an overdose. Emphasizing this point can help ensure timely intervention and potentially prevent serious health consequences.

Storage and Handling

The product is supplied in a secure carton, and it is essential to store it at a temperature range of 20° to 25°C (68° to 77°F). Healthcare professionals should ensure that the carton remains closed and intact; the product must not be used if the carton is open or if the printed foil seal under the cap is torn or missing. Proper handling and storage conditions are crucial to maintain the integrity and efficacy of the product.

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 experience.

Drug Information (PDF)

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

View product document (PDF)