Duralgina

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, muscular aches, minor arthritis pain, menstrual cramps, common cold, backaches, and toothaches. Additionally, it is utilized 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 instructed to take 2 tablets every 4 to 6 hours as needed. The maximum allowable dosage is 12 tablets within a 24-hour period, unless otherwise directed by a physician.

For children aged 6 to 11 years, the recommended dosage is 1 tablet every 4 to 6 hours as needed. The total intake should not exceed 6 tablets in a 24-hour period, unless advised by a healthcare professional.

For children under 6 years of age, it is recommended to consult a doctor for appropriate dosing guidance.

Contraindications

Use of this product is contraindicated in the following situations:

• The product should be kept out of reach of children to prevent accidental ingestion.

• In the event of an overdose, immediate medical assistance should be sought or contact with a Poison Control Center is advised.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen, under certain conditions. Healthcare professionals should advise patients that the risk of liver injury increases significantly if they exceed 12 tablets within a 24-hour period, use this product concurrently with other medications containing acetaminophen, or consume three or more alcoholic beverages daily.

It is imperative that this product not be used in conjunction with any other drug containing acetaminophen, whether prescription or over-the-counter. Patients should be encouraged to consult a healthcare provider or pharmacist if they are uncertain about the presence of acetaminophen in their medications. Additionally, individuals with a known allergy to acetaminophen or any inactive ingredients in the formulation should avoid use.

Patients with liver disease should seek medical advice prior to using this product. Furthermore, those taking the anticoagulant warfarin should consult a healthcare professional or pharmacist before use, as potential interactions may occur.

Patients should be instructed to discontinue use and consult a healthcare provider if any of the following occur: pain worsens or persists beyond 10 days, fever intensifies or lasts more than 3 days, new symptoms develop, or if there is persistent redness or swelling. These symptoms may indicate a serious underlying condition that requires further evaluation.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222. Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Side Effects

Severe liver damage may occur in patients who exceed the recommended dosage of more than 12 tablets within a 24-hour period, use the product in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily. It is imperative that patients do not use this product alongside any other drug containing acetaminophen, whether prescription or non-prescription. Individuals who are allergic to acetaminophen or any of the inactive ingredients in the formulation should also refrain from use.

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

Patients are instructed to discontinue use and consult a healthcare provider if pain worsens or persists beyond 10 days, if fever intensifies or lasts more than 3 days, if new symptoms arise, or if there is persistent redness or swelling. These symptoms may indicate the presence of a serious condition that requires medical attention.

Drug Interactions

Acetaminophen may interact with the anticoagulant warfarin, potentially increasing the risk of bleeding. It is advisable for patients to consult with a healthcare professional, such as a doctor or pharmacist, prior to using acetaminophen if they are currently taking warfarin.

No additional drug interactions or laboratory test interactions have been identified for acetaminophen.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 12 years and older may take 2 tablets every 4-6 hours as needed, with a maximum of 12 tablets in a 24-hour period unless otherwise directed by a healthcare professional. For children aged 6 to 11 years, the recommended dosage is 1 tablet every 4-6 hours as needed, not to exceed 6 tablets in 24 hours unless advised by a doctor. For children under 6 years of age, consultation with a healthcare provider is required before administration.

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 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 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 exercise caution when using this product, which contains acetaminophen. It is critical to note that severe liver damage may occur if patients exceed the recommended dosage of 12 tablets within a 24-hour period. Additionally, the risk of severe liver damage is heightened if acetaminophen is taken concurrently with other medications that also contain acetaminophen.

Patients with compromised liver function are advised to consult a healthcare professional prior to use, particularly if they have a history of liver disease. Furthermore, consumption of three or more alcoholic drinks daily may significantly increase the risk of severe liver damage when using this product. Monitoring of liver function may be warranted in patients with hepatic impairment to ensure safety and prevent potential adverse effects.

Overdosage

In cases of overdosage, significant health risks are associated with excessive intake of acetaminophen.

Risk of Severe Liver Damage Administration of more than 12 tablets within a 24-hour period can lead to severe liver damage. Healthcare professionals should be vigilant in assessing patients who may have exceeded this dosage threshold.

Additionally, the concomitant use of acetaminophen with other medications that also contain acetaminophen poses a substantial risk for severe liver damage. It is crucial for healthcare providers to review all medications a patient is taking to prevent unintentional overdose.

Furthermore, chronic consumption of three or more alcoholic drinks daily can exacerbate the risk of liver damage when acetaminophen is ingested. Patients with a history of alcohol use should be closely monitored for signs of liver toxicity.

Recommended Actions In the event of suspected overdosage, immediate medical evaluation is warranted. Healthcare professionals should initiate appropriate management procedures, which may include supportive care and monitoring of liver function tests. Early intervention is critical to mitigate the potential for severe hepatic injury.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional prior to use. This recommendation applies to both teratogenic and non-teratogenic effects, indicating a precautionary approach for individuals in these conditions.

No additional information is available regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion.

In the event of an overdose, it is crucial for patients to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Healthcare providers should emphasize that quick medical attention is essential for both adults and children, even if no signs or symptoms of overdose are apparent.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, specifically within the range of 20°C to 25°C (68°F to 77°F). It is essential to protect the product from light exposure to ensure its efficacy. Additionally, the product should be kept out of reach of children, and any unused portion should be discarded after opening to prevent potential safety risks.

Additional Clinical Information

Patients aged 12 years and older are advised to take 2 tablets every 4-6 hours as needed, with a maximum of 12 tablets in a 24-hour period unless otherwise directed by a physician. For children aged 6 to 11 years, the recommended dosage is 1 tablet every 4-6 hours as needed, not exceeding 6 tablets in 24 hours unless directed by a doctor. For children under 6 years of age, consultation with a physician is recommended prior to administration.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding. It is important to keep the medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center contacted at 1-800-222-1222, as prompt medical attention is crucial for both adults and children, even in the absence of symptoms.

Drug Information (PDF)

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

View product document (PDF)