Lil Drug Store Pain Reliever

Description

Acetaminophen is a pain reliever and fever reducer, available in an extra strength formulation. Each tablet contains 500 mg of acetaminophen. The product is packaged in a bottle containing 10 tablets and is marketed under the brand Lil' DrugStore®.

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 over are advised to take 2 tablets every 6 hours as needed for symptom relief. The maximum dosage should not exceed 6 tablets within a 24-hour period unless specifically directed by a healthcare professional. Additionally, the use of this medication should not extend beyond 10 days unless instructed by a doctor.

For children under 12 years of age, it is recommended to consult a healthcare professional for appropriate dosing guidance.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, is prohibited 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.

• This product should not be used in individuals with a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation, as this may lead to severe allergic reactions.

Warnings and Precautions

This product contains acetaminophen, and it is crucial for healthcare professionals to be aware of the associated warnings and precautions to ensure safe usage.

Warnings

The maximum daily dose of this product is 6 tablets (3,000 mg) within a 24-hour period. Severe liver damage may occur if the following conditions are met: exceeding 4,000 mg of acetaminophen in 24 hours, concomitant use with other medications containing acetaminophen, or consumption of 3 or more alcoholic drinks daily while using this product.

Additionally, there is an allergy alert associated with acetaminophen, which may lead to severe skin reactions. Symptoms of such reactions can include skin reddening, blisters, and rash. If any skin reaction occurs, it is imperative to discontinue use immediately and seek medical assistance.

General Precautions

Healthcare professionals should advise patients to consult a doctor prior to use if they have a history of liver disease. Furthermore, patients taking the anticoagulant warfarin should also seek medical advice before using this product.

Emergency Medical Help Instructions

In the event of an overdose, it is critical to obtain medical help or contact a Poison Control Center (1-800-222-1222) without delay. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are immediately apparent.

Stop Taking and Call Your Doctor Instructions

Patients should be instructed to stop use and consult a doctor if any of the following occur: pain worsens or persists for more than 10 days, fever worsens or lasts longer than 3 days, new symptoms arise, or if redness or swelling is observed. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients who exceed 4,000 mg of acetaminophen within a 24-hour period, use it in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product. Patients should be aware that acetaminophen can cause severe skin reactions, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Patients are advised not to use this product in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Those with known allergies to acetaminophen or any inactive ingredients in this product should also refrain from use.

Patients should stop using the product and consult a healthcare professional if pain worsens or persists for more than 10 days, if fever worsens or lasts more than 3 days, if new symptoms arise, or if redness or swelling is observed, as these may indicate a serious condition.

It is recommended that patients consult a doctor prior to use if they have liver disease or are taking the anticoagulant warfarin. Additionally, taking more than the recommended dose may lead to overdose and subsequent liver damage. In cases of suspected overdose, immediate medical attention is crucial for both adults and children, even if no signs or symptoms are present. Patients are encouraged to contact a Poison Control Center at 1-800-222-1222 for guidance.

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. Co-administration may lead to an increased risk of acetaminophen-related toxicity. If there is uncertainty regarding the presence of acetaminophen in other medications, patients are advised to seek guidance from a healthcare provider or pharmacist.

Packaging & NDC

Below are the non-prescription pack sizes of Lil Drug Store Pain Reliever (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosage is 2 tablets every 6 hours as needed for symptom relief, with a maximum of 6 tablets in a 24-hour period unless otherwise directed by a physician. Additionally, treatment should not exceed 10 days unless advised by a healthcare provider.

Geriatric Use

Elderly patients should consult a healthcare provider prior to using this medication, particularly if they have a history of liver disease. Additionally, it is important for geriatric patients to inform their healthcare provider if they are currently taking warfarin or any other blood-thinning medications, as potential interactions may necessitate careful monitoring or dosage adjustments.

Furthermore, this medication should not be used for more than 10 days unless specifically directed by a healthcare professional. This precaution is particularly relevant for elderly patients, who may be at increased risk for adverse effects and complications associated with prolonged use. Regular assessment and monitoring by a healthcare provider are recommended to ensure safety and efficacy in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the fetus.

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 may impact the drug's efficacy and safety profile in this population. Regular monitoring of renal function is advisable to ensure patient safety.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. The maximum daily dose is limited to 6 tablets (3,000 mg) within a 24-hour period. It is critical to note that severe liver damage may occur if patients exceed 4,000 mg of acetaminophen in 24 hours, use other medications containing acetaminophen concurrently, or consume 3 or more alcoholic drinks daily while using this product.

Patients with a history of liver disease are advised to consult a healthcare professional prior to use. Due to the risk of overdose and potential liver damage, it is essential that patients adhere strictly to the recommended dosage. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted without delay. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms of overdose are apparent.

Overdosage

In the event of an overdose, the potential for liver damage increases significantly when the recommended dosage is exceeded. It is imperative that healthcare professionals recognize the seriousness of this situation and act promptly.

Immediate medical assistance is crucial. In cases of suspected overdose, healthcare providers should advise patients or caregivers to seek medical help without delay. Contacting a Poison Control Center at 1-800-222-1222 is recommended for further guidance and support.

It is important to note that quick medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms. Vigilance in monitoring for any potential effects is necessary, as early intervention can be critical in managing the consequences of an overdose effectively.

Nonclinical Toxicology

There is no information available regarding teratogenic effects. It is advised that individuals who are pregnant or breastfeeding consult a health professional prior to use. Additionally, no data has been provided concerning nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Severe skin reactions have been reported in association with acetaminophen use, including symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

Additionally, cases of overdose have been documented, which may lead to liver damage. It is crucial for individuals who suspect an overdose to obtain medical help or contact a Poison Control Center (1-800-222-1222) without delay, as prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is important to inform 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 cautioned against using this product if they have a known allergy to acetaminophen or any of the inactive ingredients included in the formulation. They should be instructed to discontinue use and seek medical advice if their pain worsens or persists for more than 10 days, or if their fever intensifies or lasts longer than 3 days. Additionally, patients should be advised to stop using the medication and consult a healthcare professional if they experience new symptoms, or if they notice any redness or swelling, as these may indicate a serious condition.

Healthcare providers should also recommend that patients consult a doctor prior to using this medication if they have a history of liver disease or if they are currently taking the blood-thinning medication warfarin. This precaution is essential to ensure the safe and effective use of the product.

Storage and Handling

The product is supplied in vials that must not be used if the vial is open, damaged, or if the safety seal has been removed. It is essential to store the product at room temperature, specifically within the range of 59-86°F (15-30°C). Proper handling and storage conditions are critical to ensure the integrity and safety of the product.

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. No further information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Lil Drug Store Pain Reliever, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)