Acetaminophen

Description

The product is available in two National Drug Code (NDC) configurations: 17714-012-01, which contains 100 units per count, and 17714-012-10, which contains 1000 units per count.

Uses and Indications

This drug is indicated for the temporary reduction of fever and the relief of minor aches and pains associated with various conditions, including the common cold, headache, toothache, muscular aches, and premenstrual or menstrual cramps.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For adults and children aged 12 years and older, the recommended dosage is 1 to 2 tablets every 4 hours or 2 to 3 tablets every 6 hours, as needed while symptoms persist. The total daily dosage should not exceed 12 tablets within a 24-hour period.

For children aged 6 to 11 years, the dosage is 1 tablet every 4 hours while symptoms last, with a maximum of 5 tablets in a 24-hour period.

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

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should be aware of the following critical warnings regarding its use:

Liver Warning The risk of severe liver damage increases under the following circumstances:

• An adult consumes more than 12 tablets within a 24-hour period, which is the maximum recommended daily dosage.

• A child consumes more than 5 tablets within a 24-hour period, which is also the maximum recommended daily dosage.

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

• An adult consumes three or more alcoholic beverages daily while using this product.

It is imperative that this product is not used in conjunction with any other medications containing acetaminophen, whether prescription or over-the-counter. If there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare provider is advised.

Pre-existing Conditions Healthcare professionals should advise patients to consult a doctor prior to use if they have a history of liver disease. Additionally, patients taking the anticoagulant warfarin should seek guidance from a healthcare provider or pharmacist before using this product.

Monitoring and Follow-Up Patients should be instructed to discontinue use and contact their healthcare provider if any of the following occur:

• An adult's pain worsens or persists for more than 10 days.

• A child's pain worsens or lasts longer than 5 days.

• Fever worsens or lasts more than 3 days.

• Signs of redness or swelling are observed.

• Any new symptoms develop.

Emergency Situations 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 signs or symptoms are immediately apparent.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if the maximum daily dosage is exceeded. Specifically, adults should not exceed 12 tablets in a 24-hour period, while children should not take more than 5 tablets within the same timeframe. The risk of liver damage is heightened if the product is taken concurrently with other medications containing acetaminophen or if an adult consumes three or more alcoholic drinks daily while using this product.

Patients are advised against using this product in conjunction with any other drug that contains acetaminophen, whether prescription or non-prescription. If there is uncertainty regarding the presence of acetaminophen in another medication, consultation with a healthcare professional is recommended.

Prior to use, patients with liver disease should seek medical advice. Additionally, individuals taking the anticoagulant warfarin should consult a doctor or pharmacist before using this product.

Patients should discontinue use and consult a healthcare professional if any of the following occur: worsening pain that lasts more than 10 days in adults or more than 5 days in children, fever that worsens or persists for more than 3 days, presence of redness or swelling, or the emergence of any new symptoms.

For those who are pregnant or breastfeeding, it is advisable to consult a health professional before using this product.

Drug Interactions

Co-administration of this medication with any other drug containing acetaminophen, whether prescription or non-prescription, 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 Acetaminophen. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 6 to 11 years may be administered 1 tablet every 4 hours as needed for symptom relief, with a maximum of 5 tablets in a 24-hour period. For children under 6 years, consultation with a healthcare professional is advised prior to use.

It is important to note the liver warning associated with exceeding the maximum daily dosage of 5 tablets. Healthcare providers should instruct caregivers to discontinue use and seek medical advice if the child's pain worsens or persists beyond 5 days, or if fever worsens or lasts more than 3 days.

Geriatric Use

Elderly patients may not have specific dosage adjustments, safety concerns, or special precautions outlined in the prescribing information. Therefore, healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in therapeutic response, given the variability in drug metabolism and sensitivity that can occur with aging.

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 terms of dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be prudent in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should be advised that this product contains acetaminophen, which carries a risk of severe liver damage. The maximum daily dosage for adults is 12 tablets within a 24-hour period, while for children, it is 5 tablets in the same timeframe. It is crucial for patients to avoid exceeding these limits, as well as to refrain from using other medications that contain acetaminophen concurrently.

Additionally, patients who consume three or more alcoholic drinks daily should exercise caution when using this product, as this may further increase the risk of liver damage.

Before initiating treatment, patients with known liver disease should consult a healthcare professional to assess the appropriateness of this product for their condition. Regular monitoring of liver function may be warranted in these patients to ensure safety and efficacy.

Overdosage

In cases of overdosage, significant health risks are associated with the consumption of this product beyond the recommended limits.

Adult Overdosage An adult who ingests more than 12 tablets within a 24-hour period is at risk of experiencing severe liver damage. This threshold represents the maximum daily dosage recommended for adults. Additionally, the concomitant use of this product with other medications containing acetaminophen can exacerbate the risk of liver injury, even if the individual has not exceeded the maximum daily amount of this product alone.

Pediatric Overdosage For children, the risk of severe liver damage arises when more than 5 tablets are consumed within a 24-hour timeframe, which is the established maximum daily limit for pediatric patients.

Alcohol Consumption Adults who consume 3 or more alcoholic beverages daily while using this product are also at an increased risk of severe liver damage. The interaction between alcohol and the active ingredients in this product can significantly heighten the potential for hepatotoxicity.

Healthcare professionals are advised to monitor patients for symptoms of liver damage, which may include jaundice, abdominal pain, nausea, vomiting, and confusion. In the event of suspected overdosage, immediate medical attention is warranted, and appropriate management procedures should be initiated to mitigate the risk of severe hepatic injury.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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 or seek medical help without delay. It is crucial to emphasize that prompt medical attention is necessary for both adults and children, even if they do not exhibit any signs or symptoms of overdose. This proactive approach can significantly impact the outcome and safety of the patient.

Storage and Handling

The product is supplied in bulk packaging, which must be dispensed into a child-resistant closure. It is essential to use a tight, light-resistant container as specified by the United States Pharmacopeia (USP) standards.

Storage conditions require the product to be maintained at a temperature range of 15-30 °C (59-86 °F) to ensure its integrity and efficacy. Proper adherence to these storage and handling guidelines is crucial for maintaining product quality.

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. In the event of an overdose, it is crucial for patients to seek medical assistance or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, regardless of the presence of symptoms.

Drug Information (PDF)

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

View product document (PDF)