Major Extra Strength Acetaminophen Liquid

Description

The drug is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet. It is imprinted with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. The formulation includes inactive ingredients such as lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, toothache, muscular aches, the common cold, backache, minor pain from arthritis, 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 15 to 30 mL every 4 to 6 hours as needed. It is important not to exceed a total of 90 mL within a 24-hour period unless specifically directed by a healthcare professional.

For children under 12 years of age, the use of this medication is not recommended.

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.

Additionally, it is important to adhere to the recommended dosing guidelines to avoid potential adverse effects.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. The maximum recommended daily dose is 90 mL, equating to 3,000 mg of acetaminophen. Healthcare professionals should advise patients that exceeding 120 mL (4,000 mg of acetaminophen) within a 24-hour period, using this product in conjunction with other medications containing acetaminophen, or consuming three or more alcoholic beverages daily while using this product significantly increases the risk of liver damage.

Patients should be informed of the potential for allergic reactions associated with acetaminophen. Symptoms may include skin reddening, blisters, and rash. In the event of a skin reaction, patients must discontinue use immediately and seek medical assistance.

General precautions should be taken for patients with pre-existing liver disease. It is advisable for these patients to consult a healthcare provider prior to using this product. Additionally, patients who are taking the anticoagulant warfarin should also seek medical advice before use, as interactions may occur.

In the case of an overdose, immediate medical attention is critical. Patients should be instructed to contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help without delay.

Patients should discontinue use and consult a healthcare professional if any of the following occur: worsening pain that lasts longer than 10 days, fever that persists or worsens beyond 3 days, the emergence of new symptoms, or the presence of redness or swelling, as these may indicate a serious underlying condition.

Side Effects

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

Severe liver damage may occur if patients exceed the maximum daily dose of 90 mL (4,000 mg of acetaminophen) within a 24-hour period. This risk is heightened if patients take more than 120 mL in 24 hours, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

Additionally, patients should be vigilant for signs of allergic reactions, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, patients are advised to discontinue use immediately and seek medical assistance.

Patients are also instructed to stop use and consult a healthcare professional if pain worsens or persists beyond 10 days, if fever intensifies or lasts more than 3 days, if new symptoms arise, or if redness or swelling occurs, as these may indicate a serious underlying condition.

Drug Interactions

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking warfarin, a blood-thinning agent. The combination may increase the risk of bleeding due to potential pharmacodynamic interactions.

Additionally, this medication should not be used in conjunction with any other products containing acetaminophen, whether prescription or over-the-counter. Patients are advised to verify the presence of acetaminophen in other medications by consulting a healthcare provider or pharmacist to avoid unintentional overdose and associated adverse effects.

Packaging & NDC

Below are the non-prescription pack sizes of Major Extra Strength Acetaminophen Liquid (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For adolescents aged 12 years and older, the recommended dosage is 15 to 30 mL every 4 to 6 hours as needed, with a maximum of 90 mL in a 24-hour period unless otherwise directed by a healthcare professional.

It is essential to keep this medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including 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 lack of targeted data for 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 or nursing infant.

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 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 patients is 90 mL within a 24-hour period. It is critical to note that severe liver damage may occur if patients exceed the following limits:

• More than 120 mL (4,000 mg of acetaminophen) in 24 hours.

• Concurrent use with other medications containing acetaminophen.

• Consumption of three or more alcoholic drinks daily while using this product.

Due to the potential for increased risk of liver damage, patients with compromised liver function should be advised to adhere strictly to the recommended dosage and to avoid the aforementioned conditions. Regular monitoring of liver function may be warranted in these patients to ensure safety and prevent adverse effects.

Overdosage

Severe liver damage may occur with the ingestion of acetaminophen, particularly when the maximum daily dose is exceeded. The recommended maximum daily dose for this product is 90 mL within a 24-hour period. Healthcare professionals should be vigilant for signs of overdosage, which can occur under the following circumstances:

1. Exceeding Maximum Dosage: Taking more than 120 mL (equivalent to 4,000 mg of acetaminophen) within a 24-hour timeframe significantly increases the risk of liver damage.

2. Concurrent Use with Other Acetaminophen-Containing Products: The risk of hepatotoxicity is heightened when this product is used in conjunction with other medications that also contain acetaminophen.

3. Alcohol Consumption: The consumption of three or more alcoholic drinks daily while using this product can exacerbate the potential for liver injury.

In the event of suspected overdosage, it is imperative to seek immediate medical attention. Healthcare providers should assess the patient for symptoms of liver damage, which may include nausea, vomiting, loss of appetite, confusion, jaundice, and abdominal pain. Management of acetaminophen overdosage typically involves the administration of N-acetylcysteine (NAC) as an antidote, particularly if treatment is initiated within 8 to 10 hours of ingestion. Continuous monitoring of liver function tests is also recommended to evaluate the extent of liver injury and guide further management.

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

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children. In the event of an overdose, patients should seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

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 whether a drug contains acetaminophen, they should be encouraged to consult with a doctor or pharmacist.

It is important to instruct patients not to use this product if they have a known allergy to acetaminophen or any of the inactive ingredients present in the formulation. Additionally, patients should be advised to consult a doctor before using this medication if they have liver disease or are currently taking the blood-thinning medication warfarin.

While using this product, patients must be cautioned not to exceed the recommended dose. They should be instructed to stop use and seek medical advice if their pain worsens or persists for more than 10 days, if their fever intensifies or lasts longer than 3 days, if new symptoms arise, or if they notice any redness or swelling, as these may indicate a serious condition.

Storage and Handling

The product is supplied in a container that must be stored at a temperature range of 20°C to 25°C (68°F to 77°F). It is essential to protect the product from light exposure to maintain its integrity. The bottle should be kept tightly closed when not in use to prevent contamination and degradation. Additionally, any unused product should be discarded after opening to ensure safety and efficacy.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a healthcare professional prior to use. It is also important to instruct patients to keep the medication out of reach of children and to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222) in the event of an overdose. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

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

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