Counteract

Description

The drug is supplied in a bottle. The effective date of the insert is May 2, 2016.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, the common cold, 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 older are instructed to take 2 caplets every 4 to 6 hours as needed while symptoms persist. The maximum allowable dosage is 8 caplets within a 24-hour period. Continuous use should not exceed 10 days unless directed by a healthcare professional.

For children under 12 years of age, this adult extra strength product is contraindicated, as it may result in an overdose of acetaminophen, potentially leading to severe liver damage. Healthcare professionals should advise against the use of this product in this age group.

Patients are cautioned not to exceed the recommended dosage, and they should be made aware of the overdose warning associated with this medication.

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 potential for acetaminophen overdose, which can lead to serious 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 advise patients to adhere strictly to the following guidelines to mitigate the risk of liver injury.

Liver Warning Patients must not exceed 8 caplets within a 24-hour period, as this represents the maximum daily dosage. Additionally, the concurrent use of other medications containing acetaminophen, whether prescription or nonprescription, is contraindicated. Consumption of three or more alcoholic beverages daily while using this product is also discouraged due to the increased risk of liver damage.

General Precautions It is imperative that patients do not combine this product with any other acetaminophen-containing medications. If there is uncertainty regarding the presence of acetaminophen in other medications, patients should consult a healthcare professional, such as a doctor or pharmacist, for clarification.

Stop Taking and Call Your Doctor Instructions Patients should be instructed to discontinue use and seek medical advice if any of the following occur: pain worsens or persists beyond 10 days, fever intensifies or lasts more than 3 days, new symptoms arise, or if there is any redness or swelling. These symptoms may indicate a serious underlying condition that requires further evaluation.

Healthcare professionals are encouraged to monitor patients for these signs and symptoms to ensure timely intervention if necessary.

Side Effects

Patients using this product should be aware of the potential for serious adverse reactions, particularly related to liver health. A boxed warning indicates that the product is tamper evident; it should not be used if the imprinted safety seal under the cap is broken or missing.

The product contains acetaminophen, which carries a significant risk of severe liver damage if the maximum daily dosage of 8 caplets is exceeded within a 24-hour period, if it is taken concurrently with other medications containing acetaminophen, or if consumed with three or more alcoholic drinks daily while using this product. Overdosage may lead to liver damage, and in such cases, it is imperative to seek medical assistance or contact a Poison Control Center immediately. Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Patients are advised to discontinue use and consult a healthcare professional if pain worsens or persists beyond 10 days, if fever intensifies or lasts more than 3 days, or if new symptoms arise, including redness or swelling, as these may indicate a serious condition.

Additionally, individuals with liver disease should consult a doctor before using this product. It is also recommended that patients taking the anticoagulant warfarin seek advice from a healthcare provider or pharmacist prior to use.

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 using this medication in conjunction with warfarin, a blood-thinning agent. Patients should consult a healthcare professional, such as a doctor or pharmacist, prior to use if they are currently taking warfarin. Monitoring of coagulation parameters may be warranted to ensure safe and effective use.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should not use this adult extra strength product, as it may result in an overdose of acetaminophen, leading to potential liver damage. It is crucial to adhere to the recommended dosing guidelines to ensure the safety of pediatric patients.

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. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in 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 text. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing to this population. Regular monitoring of renal function may be warranted in patients with reduced kidney function to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. Severe liver damage may occur if patients exceed the maximum daily dosage of 8 caplets within a 24-hour period. Additionally, patients should avoid concomitant use of other medications that contain acetaminophen, as this can further increase the risk of liver injury.

It is also important for patients with compromised liver function to limit alcohol consumption. Specifically, the intake of 3 or more alcoholic drinks per day while using this product may significantly heighten the risk of severe liver damage.

Monitoring of liver function is recommended for patients with hepatic impairment who are prescribed this product, particularly if they are at risk of exceeding the recommended dosage or consuming alcohol concurrently. Regular assessment of liver enzymes may be warranted to ensure patient safety and to mitigate the risk of hepatotoxicity.

Overdosage

In the event of an overdose, it is crucial to recognize that exceeding the recommended dosage may lead to significant liver damage. Healthcare professionals are advised to act promptly in such situations.

Recommended Actions In cases of suspected overdose, immediate medical assistance should be sought. It is imperative to contact a Poison Control Center without delay; the national hotline can be reached at 1-800-222-1222. Quick intervention is essential for both adults and children, even in the absence of observable signs or symptoms of overdose.

Potential Symptoms While specific symptoms of overdose may not be detailed, the risk of liver damage underscores the importance of vigilance and prompt medical evaluation.

Management Procedures Upon contacting medical professionals or a Poison Control Center, further instructions will be provided based on the specific circumstances of the overdose. Continuous monitoring and supportive care may be necessary to manage the patient's condition effectively.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Patients should be advised to keep this medication out of reach of children to prevent accidental ingestion. It is important to inform patients that they should not use this medication in conjunction with any other drug that contains acetaminophen, whether prescription or nonprescription. If patients are uncertain about whether a drug contains acetaminophen, they should be encouraged to consult with a doctor or pharmacist for clarification.

Patients should be instructed to discontinue use and seek medical advice if they experience any of the following: if pain worsens or persists for more than 10 days, if fever worsens or lasts longer than 3 days, or if new symptoms arise, including redness or swelling, as these may indicate a serious condition.

Additionally, patients should be advised to consult a doctor before using this medication if they have a history of liver disease. It is also essential for patients to discuss their current medications with a healthcare provider, particularly if they are taking the blood-thinning medication warfarin, as this may require special consideration.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature to maintain its integrity and efficacy. No special handling requirements are necessary beyond standard storage practices.

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 experiences.

Drug Information (PDF)

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

View product document (PDF)