Ringl

Description

The drug is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet. Each tablet is debossed with "R" on one side and "34089" on the other side, containing 500 mg of Acetaminophen. The formulation includes the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, stearic acid, povidone, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide, iron oxide red, and iron oxide yellow.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including colds, sore throat, headache, toothache, muscular aches, backache, and dysmenorrhea related to the premenstrual and menstrual periods. Additionally, it is indicated for the relief of minor pain from arthritis and for the reduction of fever.

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 as needed while symptoms persist. The total daily dosage should not exceed 6 doses or 12 tablets within a 24-hour period, unless otherwise directed by a physician.

For children aged 11 years to under 12 years, the dosage is 1 to 1.5 tablets every 4 hours while symptoms persist, with a maximum of 5 doses or 7.5 tablets in a 24-hour period, or as directed by a healthcare professional.

For children aged 9 years to under 11 years, the recommended dosage is 1 tablet every 4 hours while symptoms persist, not to exceed 5 doses or 5 tablets in 24 hours, or as directed by a physician.

For children aged 6 years to under 9 years, the dosage is also 1 tablet every 4 hours while symptoms persist, with a maximum of 5 doses or 5 tablets in a 24-hour period, or as directed by a healthcare professional.

For children aged 4 years to under 6 years, the recommended dosage is 3/4 tablet every 4 hours while symptoms persist, not to exceed 5 doses or 3.75 tablets in 24 hours, or as directed by a physician.

For children aged 3 years to under 4 years, the dosage is 1/2 tablet every 4 hours while symptoms persist, with a maximum of 5 doses or 2.5 tablets in a 24-hour period, or as directed by a healthcare professional.

For children under 3 years of age, it is advised to consult a physician for appropriate dosing recommendations.

Contraindications

Use of this product is contraindicated in patients who are concurrently taking any other medication that contains acetaminophen, whether prescription or nonprescription. This is due to the risk of acetaminophen overdose, which can lead to severe liver damage. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

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 Adults should not exceed 12 tablets within a 24-hour period, as this is the maximum daily dosage. For children, the maximum is 5 doses in 24 hours. Caution is advised when this product is taken in conjunction with other medications containing acetaminophen. Additionally, adults who consume three or more alcoholic drinks daily while using this product are at increased risk for liver damage.

General Precautions Prior to use, it is essential to consult a healthcare provider if the user has a history of liver disease. Furthermore, individuals taking the anticoagulant warfarin should seek advice from a doctor or pharmacist before using this product, as interactions may occur.

Emergency Medical Help In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center without delay. Prompt intervention is crucial for both adults and children, even if no symptoms are initially apparent.

Discontinuation and Consultation Users should discontinue use and consult a healthcare professional if any of the following occur:

• Pain persists for more than 10 days in adults or 5 days in children.

• A sore throat lasts longer than 2 days.

• Fever persists for more than 3 days, or if a severe sore throat develops.

• Sore throat is accompanied or followed by fever, headache, rash, nausea, or vomiting.

• Pain or fever worsens or new symptoms arise.

• Redness or swelling is observed.

• In cases involving children under 12 years of age, if pain persists for more than 10 days or redness is present.

Healthcare professionals should ensure that patients are adequately informed of these warnings and precautions to promote safe and effective use of the product.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed the recommended dosage. Specifically, adults should not take more than 12 tablets in a 24-hour period, while children should not take more than 5 doses in the same timeframe. The risk of liver damage is heightened if the product 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 are advised to discontinue use and consult a healthcare professional if pain persists for more than 10 days in adults or 5 days in children. Additionally, a sore throat that lasts more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting should prompt medical consultation. Other concerning symptoms include worsening pain or fever, the emergence of new symptoms, or the presence of redness or swelling. For those using the product for pain or arthritis, it is important to seek medical advice if pain persists beyond 10 days or if redness is observed, particularly in children under 12 years of age.

Patients with liver disease or those taking the anticoagulant warfarin should consult a healthcare provider before using this product. It is also crucial to avoid administering this medication to children under 3 years of age or for the treatment of arthritis pain in children.

In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

Drug Interactions

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

Pediatric Use

Pediatric patients under 3 years of age should not be administered this medication. Additionally, it is contraindicated for use in children for the treatment of arthritis-related pain. Caution is advised when considering treatment options for this population.

Geriatric Use

Elderly patients may not have specific dosage adjustments, safety concerns, or special precautions outlined for the use of this medication. Therefore, healthcare providers should exercise caution 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 general considerations for pharmacokinetics and pharmacodynamics in 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 on the excretion of this drug 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. The maximum recommended dosage for adults is 12 tablets within a 24-hour period; exceeding this limit may result in severe liver damage. For pediatric patients, the maximum is 5 doses in a 24-hour period, and exceeding this dosage may also lead to severe liver damage.

Additionally, patients with compromised liver function should be aware that the risk of severe liver damage increases when this product is taken in conjunction with other medications containing acetaminophen. Furthermore, adults consuming 3 or more alcoholic beverages daily while using this product are at an elevated risk for severe liver damage. Monitoring of liver function may be warranted in patients with existing liver disease or those who exceed recommended dosages.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. 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 lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, it is essential to monitor the patient closely and provide appropriate care as needed.

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 question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

Postmarketing experience has identified rare cases of severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, associated with the use of acetaminophen. Additionally, reports of acute liver failure have been noted in patients taking acetaminophen, particularly among those with underlying liver disease or those exceeding the recommended dosage. Instances of allergic reactions, including anaphylaxis, have also been documented following the administration of acetaminophen. Furthermore, there have been reports of renal impairment and acute kidney injury in patients using acetaminophen, especially in individuals with pre-existing kidney conditions or those consuming high doses.

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 or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

Patients should be informed not to use this medication in conjunction with any other drug containing 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.

Healthcare providers should instruct patients to discontinue use and consult a doctor if pain persists for more than 10 days in adults or 5 days in children. Additionally, patients should be advised to stop use and seek medical advice if a sore throat lasts more than 2 days.

Patients should be made aware of specific symptoms that warrant immediate medical consultation, including: fever persisting for more than 3 days, a severe sore throat, a sore throat accompanied or followed by fever, headache, rash, nausea, or vomiting, worsening pain or fever, the emergence of new symptoms, or the presence of redness or swelling.

For those using the medication for pain or arthritis, it is important to inform them to stop use and consult a doctor if pain persists for more than 10 days or if redness is observed. Furthermore, healthcare providers should caution patients to seek medical advice if they have conditions affecting children under 12 years of age.

Patients with liver disease should be advised to consult a doctor before using this medication. Additionally, those taking the blood-thinning medication warfarin should be encouraged to speak with a doctor or pharmacist prior to use.

Storage and Handling

The product is supplied in a tightly sealed container to ensure integrity and stability. It should be stored at a temperature range of 15° to 30°C (59° to 86°F) to maintain its efficacy. Proper storage conditions are essential for preserving the quality of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)