Pain Relief

Description

340R- Albertsons Pain Relief is identified by SPL Code 34089-3. This product is available in a dosage form of 100 count tablets. The labeling indicates its intended use for pain relief.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, muscular aches, backache, minor pain of arthritis, the common cold, toothache, 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 instructed 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, unless otherwise directed by a healthcare professional. Additionally, the use of this medication should not extend beyond 10 days unless specifically advised by a doctor.

For children aged 6 years to under 12 years, the recommended dosage is 1 tablet every 4 to 6 hours while symptoms last. The total daily intake must not exceed 5 tablets, and the duration of use should not exceed 5 days unless directed by a healthcare provider.

For children under 6 years of age, it is advised 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, is prohibited. If there is uncertainty regarding the presence of acetaminophen in another medication, 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.

Warnings and Precautions

This product contains acetaminophen, which carries specific warnings and precautions that healthcare professionals must consider to ensure safe use.

Liver Warning The maximum daily dosage for adults is limited to 10 tablets (3,250 mg) within a 24-hour period, while for children, it is restricted to 5 tablets (1,625 mg) in the same timeframe. Severe liver damage may occur under the following circumstances: if an adult consumes more than 4,000 mg of acetaminophen in 24 hours; if a child exceeds 5 doses in 24 hours, which is the maximum daily allowance; if the product is taken concurrently with other medications containing acetaminophen; or if an adult consumes 3 or more alcoholic beverages daily while using this product.

Allergy Alert Acetaminophen may induce severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Discontinuation Criteria Healthcare professionals should advise patients to stop using this product and consult a physician if any of the following occur: pain worsens or persists for more than 10 days in adults; pain worsens or 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.

Pre-Use Consultation Patients should be instructed to consult a physician prior to using this product if they have a history of liver disease. Additionally, it is advisable for patients to seek guidance from a doctor or pharmacist if they are currently taking the anticoagulant medication warfarin, as interactions may occur.

Side Effects

Severe adverse reactions associated with this product include significant liver damage, which may occur if an adult exceeds 4,000 mg of acetaminophen in a 24-hour period, or if a child takes more than the maximum daily amount of 5 doses (1,625 mg). The risk of liver damage is further heightened when this 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 should be aware of the potential for severe skin reactions, which may 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.

In cases of overdose, it is crucial to obtain medical help or contact a Poison Control Center without delay, as prompt medical attention is essential for both adults and children, even in the absence of noticeable symptoms.

Patients are advised to stop using this product and consult a healthcare professional if pain worsens or persists beyond 10 days in adults, or beyond 5 days in children under 12 years. Additionally, if fever worsens or lasts more than 3 days, new symptoms arise, or if redness or swelling is observed, medical advice should be sought, as these may indicate a serious condition.

Before using this product, individuals with liver disease should consult a healthcare provider. Furthermore, it is recommended that patients taking the blood-thinning medication warfarin seek guidance from a doctor or pharmacist prior to use.

Drug Interactions

Patients taking warfarin, a blood-thinning medication, should consult 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 Pain Relief (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 6 years to under 12 years may take 1 tablet every 4 to 6 hours as needed for symptom relief, with a maximum of 5 tablets (1,625 mg) in a 24-hour period. Treatment should not exceed 5 consecutive days unless directed by a healthcare professional.

For children under 6 years, consultation with a doctor is advised prior to use.

It is important to note the liver warning associated with this medication; exceeding the maximum daily dose of 5 tablets can lead to severe liver damage. Parents and caregivers should discontinue use and seek medical advice if a child's pain worsens or persists for more than 5 days in those under 12 years of age.

Geriatric Use

Elderly patients should consult a healthcare provider prior to use if they have liver disease, as this may affect the safety and efficacy of the medication. Additionally, it is important for geriatric patients to seek advice from a doctor or pharmacist if they are concurrently taking the blood-thinning medication warfarin, due to potential interactions that could increase the risk of bleeding.

For elderly patients, it is crucial to adhere to the recommended dosage guidelines. Patients should not exceed 10 tablets within a 24-hour period unless specifically directed by a healthcare professional. Furthermore, the use of this medication should not extend beyond 10 days unless advised by a doctor, to minimize the risk of adverse effects and ensure appropriate monitoring of the patient's condition.

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 considered in these populations to ensure the safety of both the mother and the fetus or 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 drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution when prescribing to patients with renal impairment, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. The maximum daily dose for adults is 10 tablets (3,250 mg) within a 24-hour period, while for children, it is limited to 5 tablets (1,625 mg) in the same timeframe.

Severe liver damage may occur if the following conditions are met: an adult consumes more than 4,000 mg of acetaminophen in a 24-hour period, a child exceeds 5 doses in 24 hours, the product is taken concurrently with other medications containing acetaminophen, or an adult consumes 3 or more alcoholic drinks daily while using this product.

Due to the potential for increased risk of liver toxicity, it is recommended that patients with compromised liver function adhere strictly to the prescribed dosage and avoid concurrent use of other acetaminophen-containing products. Regular monitoring of liver function tests may be warranted in these patients to ensure safety and efficacy.

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 severity of symptoms may vary depending on the specific substance involved in the overdose. Therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures should include the following steps:

1. Assessment of Symptoms: Continuous monitoring for any signs of toxicity or adverse reactions is necessary. Symptoms may not be immediately apparent, thus vigilance is required.

2. Supportive Care: Provide supportive care as needed, which may include maintaining airway patency, ensuring adequate ventilation, and monitoring vital signs.

3. Decontamination: If appropriate and within the timeframe, consider decontamination measures such as activated charcoal, following established protocols.

4. Specific Antidotes: If a specific antidote is available for the substance involved, it should be administered as per established guidelines.

5. Hospitalization: Depending on the severity of the overdose and the patient's condition, hospitalization may be required for further observation and treatment.

In summary, the management of an overdose requires a systematic approach, prioritizing rapid response and comprehensive care to mitigate potential complications.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified. Additionally, there are no detailed findings related to nonclinical toxicology or animal pharmacology and toxicology available.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. Patients should be informed not to use this product in conjunction with any other medications that contain 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 crucial to inform patients not to use this medication if they have a known allergy to acetaminophen or any of the inactive ingredients present in the product. Patients should be instructed 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 patient experiences a fever that worsens or lasts more than 3 days, they should stop using the medication and consult a doctor.

Patients should also be made aware that the emergence of new symptoms, or the presence of redness or swelling, warrants immediate medical consultation, as these may indicate a serious condition. It is important to advise patients to seek medical advice before using this product if they have liver disease. Furthermore, patients taking the blood-thinning medication warfarin should be encouraged to consult with a doctor or pharmacist prior to using this product.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. It should be stored at a controlled room temperature of 25°C (77°F). Temporary excursions are permitted within the range of 15°C to 30°C (59°F to 86°F). It is essential to adhere to the expiration date indicated on the package to ensure product efficacy and safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)