Regular Strength Pain Relief

Description

CVS Regular Strength Pain Relief contains acetaminophen as its active ingredient, with each liquid gel delivering a dosage of 325 mg. This formulation is available in a package containing 20 liquid gels. The product is identified by the National Drug Code (NDC) 69842-075-15. It is comparable to the active ingredient found in TYLENOL® Regular Strength.

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 advised to take 2 softgels every 4 to 6 hours as needed for symptom relief. The maximum dosage should not exceed 10 softgels within a 24-hour period. Continuous use beyond 10 days is not recommended unless directed by a healthcare professional.

For children aged 6 to 11 years, the recommended dosage is 1 softgel every 4 to 6 hours while symptoms persist. The total daily intake should not surpass 5 softgels, and usage should not extend beyond 5 days unless specifically instructed by a physician.

For children under 6 years of age, it is essential to consult a doctor before administration.

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 in the formulation, as this may lead to severe allergic reactions.

Warnings and Precautions

This product contains acetaminophen, which carries significant warnings regarding liver health. The maximum daily dosage for adults is limited to 10 softgels (3,250 mg) within a 24-hour period, while for children, the maximum is 5 softgels (1,625 mg) in the same timeframe. Severe liver damage may occur under the following circumstances:

• An adult consumes more than 4,000 mg of acetaminophen in 24 hours.

• A child exceeds 5 doses in 24 hours, which is the maximum daily allowance.

• The product is taken concurrently with other medications containing acetaminophen.

• An adult consumes 3 or more alcoholic beverages daily while using this product.

Healthcare professionals should be aware of the potential for severe skin reactions associated with acetaminophen. Symptoms may include skin reddening, blisters, and rash. If any of these reactions occur, it is imperative to discontinue use immediately and seek medical assistance.

General precautions should be observed prior to use. Patients with liver disease should consult a physician before using this product. Additionally, individuals taking the anticoagulant warfarin should seek advice from a healthcare provider or pharmacist before use.

In the event of an overdose, immediate medical attention is crucial. Patients or caregivers should contact a Poison Control Center at 1-800-222-1222 without delay, even if no symptoms are apparent, as prompt intervention is essential for both adults and children.

Patients should be advised to discontinue use 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 develop.

• Redness or swelling is observed.

These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Patients using this product should be aware of potential adverse reactions, particularly those related to liver health and allergic responses.

Severe liver damage may occur if the maximum daily dose of acetaminophen is exceeded. For adults, the maximum is 10 softgels (3,250 mg) in 24 hours, while for children, it is 5 softgels (1,625 mg) in the same timeframe. Risks increase significantly if an adult consumes more than 4,000 mg of acetaminophen in 24 hours, if a child exceeds the maximum daily amount, if the product is taken in conjunction with other medications containing acetaminophen, or if an adult consumes three or more alcoholic drinks daily while using this product.

Patients should also be vigilant for severe skin reactions, which may manifest as skin reddening, blisters, or rash. If any of these symptoms occur, it is imperative to discontinue use and seek medical assistance immediately.

In addition, patients are advised to stop use and consult a healthcare professional if pain worsens or persists beyond 10 days in adults or 5 days in children under 12 years, 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 individuals with liver disease consult a doctor prior to use. Furthermore, those taking the blood-thinning medication warfarin should seek advice from a healthcare provider or pharmacist before using this product.

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, it is advisable to seek guidance from a healthcare provider.

Packaging & NDC

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

Pediatric Use

Pediatric patients may use this medication with specific dosing considerations. For children aged 6 to 11 years, the recommended dosage is 1 softgel every 4 to 6 hours as needed, with a maximum of 5 softgels (1,625 mg) in a 24-hour period. It is advised that this age group does not use the medication for more than 5 consecutive days unless directed by a healthcare professional.

For children under 6 years of age, it is essential to consult a doctor before use to ensure safety and appropriate dosing.

Geriatric Use

Elderly patients may not have specific recommendations regarding age considerations, 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 potential for altered 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 considered in these populations to ensure maternal and fetal safety.

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

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have liver disease. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the degree of impairment. Careful evaluation of the patient's overall health status is recommended to ensure safe and effective use of the medication.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. The maximum daily dose for adults is limited to 10 softgels (3,250 mg) within a 24-hour period, while for children, the maximum is 5 softgels (1,625 mg) in the same timeframe. It is critical to note that severe liver damage may occur if the following conditions are met:

• An adult consumes more than 4,000 mg of acetaminophen within 24 hours.

• A child exceeds the maximum daily amount of 5 doses in 24 hours.

• The product is taken concurrently with other medications containing acetaminophen.

• An adult consumes 3 or more alcoholic drinks daily while using this product.

Patients with known liver disease are advised to consult a healthcare professional prior to using this product to assess the appropriateness of treatment and to determine any necessary dosage adjustments or monitoring requirements.

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 attention 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 based on the specific substance involved in the overdose. Therefore, a thorough assessment and monitoring of the patient are essential.

Management of an overdose may include supportive care and symptomatic treatment, tailored to the individual’s clinical presentation. Continuous evaluation and intervention may be necessary to address any complications that arise during the course of treatment.

It is vital to maintain open communication with poison control and other medical professionals to ensure the best possible outcomes for patients experiencing an overdose.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional prior to use. Acetaminophen has been associated with 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.

No relevant information is available regarding carcinogenicity, mutagenicity, or impairment of fertility. Additionally, there is no pertinent data provided from animal pharmacology and toxicology studies.

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions. Reports indicate that symptoms can 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 instructed 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 other medications, they should be encouraged to consult with a doctor or pharmacist.

It is essential to inform patients not to use this product if they have a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation. Patients should be made aware that they need to stop using the medication and seek medical advice if their pain worsens or persists for more than 10 days in adults, or more than 5 days in children under 12 years. Additionally, if a fever worsens or lasts more than 3 days, or if new symptoms develop, patients should be advised to discontinue use and consult a healthcare professional.

Patients should also be informed to seek medical attention if they notice any redness or swelling, as these may indicate a serious condition. Furthermore, it is important to recommend that patients consult with a doctor before using this medication if they have liver disease. Lastly, patients taking the blood-thinning medication warfarin should be advised to speak with a doctor or pharmacist prior to using this product.

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, maintaining a range of 15° to 30°C (59° to 86°F). Proper storage conditions are crucial to ensure the integrity and efficacy 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 additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)