Acetaminophen (red)

Description

Acetaminophen Capsules contain 325 mg of acetaminophen per capsule. This product is supplied in a bulk quantity of 5000 capsules, with the National Drug Code (NDC) number 53345-010-01. Upon receipt, immediate inspection is required. These capsules are intended solely for further manufacturing, processing, or repacking. It is essential to protect the capsules from heat, humidity, and light, and refrigeration is not recommended.

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 for symptom relief. 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 persist. The total daily limit for this age group is 5 softgels, and usage should not extend beyond 5 days unless specifically instructed by a physician.

For children under 6 years of age, it is recommended to consult a healthcare provider 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 poses 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 a 24-hour period.

• A child exceeds 5 doses in 24 hours, which is the maximum allowable amount.

• 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 without delay. Prompt medical attention is crucial for both adults and children, even if no symptoms are immediately 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 of age.

• 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 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 patient consumes three or more alcoholic drinks daily while using this product.

Patients with a history of liver disease should consult a healthcare professional before using this product. Additionally, individuals taking the anticoagulant warfarin are advised to seek guidance from a doctor or pharmacist prior to use.

Common adverse reactions necessitating immediate medical consultation include worsening pain that persists beyond 10 days in adults or 5 days in children under 12 years, fever that worsens or lasts more than 3 days, the emergence of new symptoms, or the presence of redness or swelling, which may indicate a serious condition.

In the event of an overdose, which may occur if the recommended dosage is exceeded, patients should seek medical assistance or contact a Poison Control Center immediately. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are initially apparent.

Drug Interactions

Patients taking warfarin, a blood-thinning medication, should consult with a healthcare professional prior to using this product. The interaction between this product and warfarin may necessitate careful monitoring of coagulation parameters to ensure therapeutic efficacy and minimize the risk of adverse effects. Adjustments to the dosage of either medication may be required based on clinical judgment and patient response.

Packaging & NDC

Below are the non-prescription pack sizes of Acetaminophen (red) (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, consultation with a doctor is advised prior to use.

It is important to note that exceeding the maximum daily dose of 5 softgels can lead to severe liver damage. Parents and caregivers should monitor for worsening pain or fever; if pain persists for more than 5 days or fever lasts more than 3 days in children under 12 years, they should discontinue use and seek medical advice.

Geriatric Use

Elderly patients may not have specific recommendations regarding age considerations, 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 therapeutic response, given the potential for altered pharmacokinetics and pharmacodynamics 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 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 the safety of both the mother and the developing fetus.

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 studied in relation to dosage adjustments, special monitoring, or safety considerations. Consequently, there is no available information regarding the use of this medication in individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to patients with renal impairment.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. It is essential to adhere to the maximum daily dose of 10 softgels (3,250 mg) for adults and 5 softgels (1,625 mg) for children within a 24-hour period. Severe liver damage may occur if the following conditions are met:

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

• A child takes more than 5 doses in 24 hours, which is the maximum daily amount.

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

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

Patients with liver disease should consult a healthcare professional before using this product. It is critical to avoid exceeding the recommended dosage, as an overdose may lead to liver damage. In the event of an overdose, immediate medical assistance should be sought, or a Poison Control Center should be contacted without delay. Prompt medical attention is vital for both adults and children, even if no signs or symptoms of overdose are apparent.

Overdosage

Taking more than the recommended dose may lead to significant liver damage. It is crucial for healthcare professionals to recognize the seriousness of an overdose situation, as prompt intervention can be vital in mitigating potential harm.

In the event of an overdose, immediate medical assistance should be sought. Healthcare providers are advised to contact a Poison Control Center without delay. Quick medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms. Early recognition and management of an overdose can greatly influence the outcome and reduce the risk of severe complications.

Nonclinical Toxicology

No teratogenic effects have been identified in the available data. Additionally, there is no information regarding non-teratogenic effects. The nonclinical toxicology section does not provide any specific details, nor does the animal pharmacology and toxicology section contain relevant information.

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 necessitating liver transplantation, particularly among patients who exceeded the recommended dose or utilized multiple acetaminophen-containing products. Instances of allergic reactions, including anaphylaxis, have also been reported. Furthermore, there have been observations of renal impairment and acute kidney injury linked to the use of acetaminophen, especially in patients with pre-existing renal conditions or those consuming high doses.

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 included in the formulation. Healthcare providers should instruct 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, patients should be advised to stop use and consult a doctor 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.

It is also essential for healthcare providers to recommend that patients consult a doctor before using this medication if they have liver disease. Furthermore, patients taking the blood-thinning medication warfarin should be advised to seek guidance from a doctor or pharmacist prior to 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, as this may compromise the integrity of the product. Proper storage conditions are crucial to ensure the product remains effective and safe for use.

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 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)