Acetaminophen (red)

Description

Acetaminophen Capsules are formulated with a dosage strength of 325 mg per capsule. This product is supplied in a bulk quantity of 4000 capsules, identified by National Drug Code (NDC) number 53345-010-02. Upon receipt, immediate inspection is required to ensure product integrity. These capsules are intended solely for further manufacturing, processing, or repacking. Proper storage conditions must be maintained; the product should be protected 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 dosage should not exceed 10 softgels within a 24-hour period. Continuous use beyond 10 days is not recommended 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 intake should not surpass 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 essential to consult a doctor before administration.

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 significant risks for liver damage. 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 be aware of the potential for severe skin reactions associated with acetaminophen. Symptoms may include skin reddening, blisters, and rash. If any of these reactions occur, the patient should discontinue use immediately and seek medical assistance.

General precautions should be taken prior to use. Patients with liver disease should consult a physician before using this product. Additionally, individuals taking the anticoagulant warfarin should seek advice from a healthcare provider or pharmacist before use.

In the event of an overdose, it is imperative to obtain emergency medical help or contact a Poison Control Center immediately at 1-800-222-1222. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are initially apparent.

Patients should be advised to 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.

These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Patients using this product should be aware of potential adverse reactions, particularly those related to liver health and allergic responses.

Severe liver damage may occur if the maximum daily dose of acetaminophen is exceeded. For adults, the maximum is 10 softgels (3,250 mg) in 24 hours, while for children, it is limited to 5 softgels (1,625 mg) in the same timeframe. Risks increase significantly if an adult consumes more than 4,000 mg of acetaminophen in 24 hours, if a child takes more than the recommended maximum daily amount, if the product is used concurrently with other medications containing acetaminophen, or if an adult consumes three or more alcoholic drinks daily while using this product.

Patients should also be vigilant for severe skin reactions, which may manifest as skin reddening, blisters, or rash. In the event of any skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Patients are advised to stop using the product and consult a healthcare professional if pain worsens or persists beyond 10 days in adults or 5 days in children under 12 years, if fever worsens or lasts more than 3 days, if new symptoms arise, or if redness or swelling is observed, as these may indicate a serious condition.

Additionally, individuals with liver disease should consult a doctor prior to use. It is also recommended that patients taking the blood-thinning medication warfarin seek advice from a healthcare provider or pharmacist before using this product.

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 may use this medication with specific dosing considerations. 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 (1,625 mg) in a 24-hour period. This age group should not use the medication for more than 5 consecutive days unless directed by a healthcare professional.

For children under 6 years of age, it is advised to consult a doctor before use. The maximum daily dose for all pediatric patients is capped at 5 softgels within a 24-hour timeframe.

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.

For dosing, elderly patients, along with adults and children aged 12 years and older, are advised to take 2 softgels every 4 to 6 hours while symptoms persist, with a maximum limit of 10 softgels in a 24-hour period. It is crucial that they do not exceed this dosage and refrain from using the medication for more than 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, with a maximum of 5 softgels in a 24-hour period, and should not be used for more than 5 days unless directed by a doctor. For children under 6 years of age, it is essential to consult a healthcare provider before administration.

Elderly patients should be closely monitored for any adverse effects, particularly if they have underlying health conditions or are taking other medications.

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, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to discuss their individual circumstances with a healthcare provider 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 medication 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 prescribing information regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients, although specific recommendations are not provided.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to using this product. It is important to note that severe liver damage may occur if an adult exceeds a dosage of 4,000 mg of acetaminophen within a 24-hour period. Additionally, patients who consume three or more alcoholic drinks daily while using this product are at an increased risk of severe liver damage. Therefore, careful consideration and monitoring of liver function are essential for patients with compromised liver function to prevent potential adverse effects.

Overdosage

In the event of an overdose, immediate medical assistance is essential. Healthcare professionals are advised to instruct patients or caregivers to seek medical help or contact a Poison Control Center without delay. The national Poison Control Center can be reached at 1-800-222-1222.

It is crucial to emphasize that prompt medical attention is necessary for both adults and children, even in the absence of noticeable signs or symptoms. Early intervention can significantly impact the outcome of an overdose situation. Therefore, vigilance and swift action are paramount in managing potential overdose cases.

Nonclinical Toxicology

No teratogenic effects have been observed in nonclinical studies. Additionally, there are no reported non-teratogenic effects. The available data does not provide any specific details regarding nonclinical toxicology or animal pharmacology and toxicology.

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 to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, it is crucial to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

Patients should be informed not to use this medication in conjunction with any other drug that contains acetaminophen, whether prescription or nonprescription. If patients are uncertain about whether a drug contains acetaminophen, they should be encouraged to consult with a doctor or pharmacist.

It is important to instruct patients to avoid using this medication if they have a known allergy to acetaminophen or any of the inactive ingredients present in the product. Additionally, patients should be advised to consult a doctor before use if they have liver disease or if they are currently taking the blood-thinning medication warfarin.

Patients should be instructed to discontinue use and seek medical advice if they experience any of the following: worsening pain that lasts more than 10 days in adults, worsening pain that lasts more than 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. These symptoms may indicate a serious condition that requires further evaluation.

Lastly, patients who are pregnant or breastfeeding should be advised to consult a healthcare professional before using this medication to ensure safety for themselves and their child.

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

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)