Acetaminophen

Description

This product is identified by the National Drug Code (NDC) 62011-0032-1 and is marketed under the Health Mart label. It contains acetaminophen as the active ingredient, with a dosage of 325 mg per tablet. The formulation is designed for pain relief and fever reduction, and it is classified as a regular strength pain reliever. Notably, this product contains no aspirin. Each bottle contains 100 tablets.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including the common cold, headache, backache, minor pain of arthritis, toothache, muscular aches, 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 dosage should not exceed 10 tablets 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 tablet every 4 to 6 hours while symptoms last. The total daily intake should not surpass 5 tablets, and use 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, 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.

• In individuals with a known allergy to acetaminophen or any of the inactive ingredients in this formulation, as this may lead to severe allergic reactions.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage under certain conditions. Adults should not exceed 4,000 mg of acetaminophen within a 24-hour period. For children, the maximum daily dosage is limited to 5 doses within the same timeframe. Caution is advised when this product is used in conjunction with other medications containing acetaminophen. Additionally, adults who consume three or more alcoholic drinks daily while using this product are at an increased risk for liver damage.

Acetaminophen may also lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of any skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

General precautions should be observed prior to use. Individuals with liver disease should consult a healthcare professional before using this product. Furthermore, those taking the anticoagulant warfarin should seek advice from a doctor or pharmacist prior to use.

In cases of overdose, it is crucial to obtain emergency medical help 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 are apparent.

Users should discontinue use and consult a healthcare provider if any of the following occur: pain worsens or persists for more than 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 symptoms may indicate a serious underlying condition that requires medical 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, while 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 the 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.

Patients are advised against using this product in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in another medication, consultation with a healthcare professional is recommended. Additionally, individuals with known allergies to acetaminophen or any inactive ingredients in this product should refrain from use.

Patients should discontinue use and consult a healthcare provider if pain worsens or persists beyond 10 days in adults, or if pain lasts more than 5 days in children under 12 years. Furthermore, 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.

It is advisable for patients to consult a healthcare professional prior to use if they have liver disease or are taking the anticoagulant warfarin, as interactions may occur.

In cases of overdose, patients should seek 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 in the absence of noticeable signs or symptoms.

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. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

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

In children under 12 years, if pain worsens or persists for more than 5 days, or if fever worsens or lasts longer than 3 days, it is advised to discontinue use and seek medical advice. The maximum daily dosage for pediatric patients is capped at 5 doses within a 24-hour timeframe.

Geriatric Use

Elderly patients may exhibit reduced kidney function and increased sensitivity to side effects, necessitating careful consideration of dosage adjustments. It is essential for healthcare providers to consult with a physician regarding the appropriate dosing and duration of use for this population.

Additionally, it is advised that elderly patients seek medical advice prior to use if they have a history of liver disease. To mitigate the risk of severe liver damage, it is important to adhere to the maximum recommended dosage of acetaminophen, which should not exceed 4,000 mg within a 24-hour period. Monitoring and individualized treatment plans are crucial to ensure the safety and efficacy of therapy in geriatric patients.

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 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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to using this product, particularly if they have a history of liver disease. The product contains acetaminophen, which poses a risk of severe liver damage under certain conditions.

Adults should not exceed 4,000 mg of acetaminophen within a 24-hour period. For pediatric patients, the maximum daily dosage is limited to 5 doses within the same timeframe. Additionally, caution is advised when this product is used concurrently with other medications containing acetaminophen, as this may lead to unintentional overdose.

Patients with compromised liver function who consume three or more alcoholic beverages daily should avoid using this product, as the combination may significantly increase the risk of liver injury. Regular monitoring of liver function may be warranted in patients with hepatic impairment who require acetaminophen, and healthcare providers should assess the risks versus benefits of continued use in these individuals.

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 presentation of symptoms may vary, and vigilance is necessary to ensure appropriate management. The potential for serious complications underscores the importance of rapid response in overdose situations.

Management procedures should include a thorough assessment of the patient's condition, monitoring vital signs, and providing supportive care as needed. It is essential to follow established protocols for overdose management, which may involve decontamination, administration of antidotes if applicable, and symptomatic treatment based on the clinical presentation.

In summary, the urgency of addressing an overdose cannot be overstated, and healthcare providers must act swiftly to mitigate risks and ensure patient safety.

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. Reported symptoms of these reactions include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use of the medication and seek medical assistance immediately.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is important to instruct 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 their other medications, they should be encouraged to consult with a doctor or pharmacist.

Patients should be informed that this medication should not be used if they have a known allergy to acetaminophen or any of the inactive ingredients contained in the product. They should be advised 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. 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. Patients with liver disease should be advised to consult a doctor before using this medication. Furthermore, those taking the blood-thinning medication warfarin should be encouraged to speak with a doctor or pharmacist prior to use to ensure safety.

Storage and Handling

The product is supplied in a carton that should be retained for complete product information. It is essential to store the product at a temperature range of 20-25°C (68-77°F) to ensure its stability and efficacy. Proper handling and storage conditions must be adhered to in order to maintain the integrity of the product.

Additional Clinical Information

The medication is administered orally. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

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)