Pain Relief

Description

This product is identified by the National Drug Code (NDC) 70677-1120-2 and is formulated as an extra strength pain reliever and fever reducer for adults. It contains acetaminophen as the active ingredient at a concentration of 50 mg per gelcap. The product is presented in a dosage form of gelcaps, with a total of 100 gelcaps per container. It is marketed under the brand name Foster & Thrive™ and is comparable to Tylenol® Extra Strength Rapid Release. The gelcaps are designed for effective pain relief.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with 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 instructed to take 2 gelcaps every 6 hours as needed while symptoms persist. The maximum dosage should not exceed 6 gelcaps 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 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:

Patients should not use this product in conjunction with any other medication 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.

Additionally, this product is contraindicated in individuals with a known allergy to acetaminophen or any of the inactive ingredients contained within the formulation, as this may lead to severe allergic reactions.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 4,000 mg of acetaminophen within a 24-hour period, concomitant use with other medications containing acetaminophen, or consumption of three or more alcoholic beverages daily while using this product.

Acetaminophen is also associated with the potential for severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare professionals should advise patients to consult a physician prior to use if they have a history of liver disease. Additionally, patients taking the anticoagulant warfarin should seek guidance from a doctor or pharmacist before using this product.

In cases of overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center at 1-800-222-1222 without delay, as prompt intervention is essential for both adults and children, even in the absence of noticeable symptoms.

Patients should also be advised to discontinue use and consult a healthcare provider if any of the following occur: worsening pain that persists beyond 10 days, a fever that worsens or lasts more than 3 days, the emergence of new symptoms, or the presence of redness or swelling. These signs 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 other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product. Patients should be aware of the potential for severe skin reactions associated with acetaminophen, 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, and should consult a healthcare professional if uncertain about the presence of acetaminophen in other medications. Additionally, individuals with a known allergy to acetaminophen or any inactive ingredients in this product should refrain from use.

Before using this product, patients with liver disease should consult a doctor. Furthermore, those taking the blood-thinning medication warfarin are encouraged to seek advice from a doctor or pharmacist prior to use.

Patients should discontinue use and consult a healthcare provider 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 occurs, as these may indicate a serious condition.

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

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 hepatotoxicity. If there is uncertainty regarding the presence of acetaminophen in other medications, patients are advised to seek guidance from a healthcare provider.

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 under 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosage is 2 gelcaps every 6 hours as needed, with a maximum of 6 gelcaps in a 24-hour period, unless otherwise directed by a physician. Treatment should not exceed 10 days without medical advice.

In cases of overdose, prompt medical attention is essential for both pediatric and adult patients, even if no signs or symptoms are immediately apparent.

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 potential adverse effects or changes in efficacy, 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 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 on 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 drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to using this product. The presence of liver disease may increase the risk of adverse effects, particularly due to the acetaminophen content.

Severe liver damage may occur if patients exceed the recommended dosage of acetaminophen, which is limited to a maximum of 4,000 mg within a 24-hour period. Additionally, patients should avoid concurrent use of other medications containing acetaminophen, as this can further elevate the risk of liver injury.

Furthermore, consumption of three or more alcoholic drinks daily while using this product is contraindicated, as it may exacerbate the potential for liver damage. Monitoring of liver function is advised in patients with compromised liver health to ensure safety and efficacy during treatment.

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 intervention is essential 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 adverse effects. Therefore, vigilance and timely medical evaluation are crucial in managing overdose situations effectively.

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 compound in these areas.

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions. Reported symptoms include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use immediately and seek medical assistance.

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 about the presence of acetaminophen in their other medications, they should be encouraged to consult with a doctor or pharmacist.

It is crucial to inform patients that they should not use this product if they have a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation. Patients 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 worsens or lasts longer than 3 days. Additionally, patients should be advised to stop using the medication and consult a doctor if they experience new symptoms, or if they notice any redness or swelling, as these may indicate a serious condition.

Patients with liver disease should be encouraged to consult a doctor before using this medication. Furthermore, those who are taking the blood-thinning medication warfarin should be advised to seek guidance from a doctor or pharmacist prior to use.

Storage and Handling

The product is supplied in a carton that should be retained for complete product information. It is essential to store the product at a temperature range of 20-25ºC (68-77ºF) to ensure its stability and efficacy. Proper handling and storage conditions must be adhered to in order to maintain the integrity of the product.

Additional Clinical Information

The medication is administered orally. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

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)