Acetaminophen (red)

Description

Acetaminophen Capsules contain 325 mg of acetaminophen per capsule. The product is supplied in bulk, consisting of 48 bags, each containing 300 capsules. The National Drug Code (NDC) for this product is 55629-718-01. Upon receipt, immediate inspection is required. This product is intended for further processing only and should be stored at a controlled temperature between 59°F to 86°F (15°C to 30°C), with precautions taken to avoid high humidity and excessive heat above 104°F (40°C).

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 over 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 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 instructed by a physician.

In the case of children under 6 years of age, it is essential to consult a doctor before administration.

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

Severe liver damage may occur with the use of this product, which contains acetaminophen. 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. It is critical to adhere to these dosage guidelines to prevent potential liver toxicity. The risk of severe liver damage increases if an adult consumes more than 4,000 mg of acetaminophen in 24 hours, if a child exceeds 5 doses in 24 hours, if the product is taken concurrently with other medications containing acetaminophen, or if an adult consumes three 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, as interactions may occur.

Patients should be instructed to discontinue use and contact a healthcare professional 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 arise, or if there is any redness or swelling. These symptoms may indicate a serious underlying condition that requires medical evaluation.

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 4,000 mg for adults or 5 doses (1,625 mg) for children may lead to severe liver damage. This risk is heightened 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 in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Individuals with known allergies to acetaminophen or any inactive ingredients in this product should also refrain from use.

Patients should discontinue use and consult a healthcare professional if pain worsens or persists beyond 10 days in adults, or beyond 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 indicate a serious condition, warranting immediate medical attention.

Before using this product, patients with liver disease should consult a healthcare provider. Furthermore, individuals taking the anticoagulant warfarin should seek advice from a doctor or pharmacist prior to use.

In the event of an overdose, it is critical to seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222. Prompt medical attention is essential for both adults and children, even if no signs or symptoms of overdose are 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 safe use and to mitigate the risk of potential bleeding complications.

Packaging & NDC

Below are the non-prescription pack sizes of Acetaminophen (red) (acetaminophen (red) - acetaminophen capsule liquid filled). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 6 years of age should consult a doctor before use. For children aged 6 to 11 years, the recommended dosage is 1 softgel every 4 to 6 hours as needed, with a maximum of 5 softgels in a 24-hour period. Use should not exceed 5 days unless directed by a healthcare professional.

In contrast, adults and children aged 12 years and older may take 2 softgels every 4 to 6 hours, with a maximum of 10 softgels in 24 hours, and should not use the medication for more than 10 days unless advised by a doctor.

It is important to note that the maximum daily dose for pediatric patients is 5 softgels (1,625 mg) within 24 hours. Healthcare providers should advise caregivers to discontinue use and seek medical advice if a child's pain worsens or persists beyond 5 days, or if a fever worsens or lasts more than 3 days.

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 treatment. 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 that pain worsens or persists for more than 10 days, elderly patients are advised to discontinue use and consult a healthcare professional. Prompt medical attention is crucial for elderly patients, even in the absence of noticeable signs or symptoms, to ensure appropriate management of their condition.

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 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 be closely monitored 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, the maximum is 5 softgels (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 avoid concurrent use of other acetaminophen-containing products. Regular monitoring of liver function tests may be warranted in these patients to ensure safety and prevent adverse effects.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the severity of symptoms may vary based on the specific substance involved in the overdose. Therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual’s clinical presentation. Continuous evaluation and appropriate interventions should be initiated as necessary to mitigate potential complications associated with the overdose.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects. Additionally, no data has been provided concerning non-teratogenic effects. The nonclinical toxicology section does not contain any relevant information at this time. Furthermore, there is no information available related to animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified rare cases of severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, associated with the use of acetaminophen. Additionally, reports of acute liver failure have been documented, with some cases resulting in liver transplantation, particularly among patients who exceed the recommended dosage or have underlying liver disease. Instances of allergic reactions, including anaphylaxis, have also been reported. Furthermore, there have been cases of renal impairment and acute kidney injury linked to the use of acetaminophen, especially in patients with pre-existing renal conditions or those taking high doses.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. Patients should be instructed to consult with a doctor or pharmacist if they are uncertain whether a drug contains acetaminophen, as it is important to avoid using this medication in conjunction with any other products that contain acetaminophen, whether prescription or nonprescription.

Patients should be made aware that they must not use this medication if they have a known allergy to acetaminophen or any of the inactive ingredients present in the product. It is crucial to inform patients to discontinue use and seek medical advice if their pain worsens or persists for more than 10 days in adults, or for more than 5 days in children under 12 years of age. Additionally, if a fever worsens or lasts more than 3 days, or if new symptoms arise, patients should be instructed to stop use and consult a doctor.

Healthcare providers should also emphasize the importance of seeking medical attention if patients experience any redness or swelling, as these may indicate a serious condition. It is advisable to ask patients about their liver health prior to use, as those with liver disease should consult a doctor before taking this medication. Furthermore, patients taking the blood-thinning medication warfarin should be encouraged to speak with a doctor or pharmacist before using this product.

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 room temperature, maintaining a range of 15° to 30°C (59° to 86°F). Care should be taken to avoid exposure to excessive heat, which may compromise the integrity of the product. Proper storage conditions are crucial to ensure the product's efficacy and 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. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)