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Apinophen

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This product has been discontinued

Active ingredient
Acetaminophen 500 mg
Other brand names
Dosage form
Tablet
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2013
Label revision date
January 2, 2014
Active ingredient
Acetaminophen 500 mg
Other brand names
Dosage form
Tablet
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2013
Label revision date
January 2, 2014
Manufacturer
A P J Laboratories Limited
Registration number
part343
NDC root
46084-061

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Drug Overview

This medication is designed to temporarily relieve minor aches and pains caused by various conditions, including the common cold, headaches, backaches, toothaches, and muscular aches. It can also help alleviate minor pain associated with arthritis and menstrual cramps. Additionally, this drug is effective in temporarily reducing fever, making it a versatile option for managing discomfort and fever symptoms.

Uses

You can use this medication to temporarily relieve minor aches and pains caused by various conditions, including the common cold, headaches, backaches, and toothaches. It is also effective for easing minor arthritis pain, muscular aches, and cramps associated with menstruation or premenstrual syndrome. Additionally, this medication can help reduce fever for a short period.

Rest assured, there are no known teratogenic effects (which means it does not cause birth defects) associated with this medication.

Dosage and Administration

When you need relief from your symptoms, adults and children aged 12 years and older can take 2 caplets every 6 hours as needed. It's important to swallow the caplets whole, so avoid crushing, chewing, or dissolving them. Make sure not to exceed 6 caplets in a 24-hour period unless your doctor advises otherwise.

Additionally, you should not use this medication for more than 10 days unless directed by a healthcare professional. If you have a child under 12 years old who needs this medication, be sure to consult a doctor first for guidance.

What to Avoid

It seems that the information regarding what to avoid while using this medication is not specified in the provided text. However, it's important to remember that certain medications may have specific contraindications (conditions or factors that serve as reasons to withhold treatment) or risks associated with misuse and dependence (a condition where the body becomes reliant on a substance).

To ensure your safety, always consult with your healthcare provider about any medications you are considering. They can provide guidance on what to avoid, including any specific instructions on use, potential risks, and how to use the medication safely. If you have any concerns about dependence or misuse, discussing these with your doctor is crucial.

Side Effects

Taking this medication comes with important safety information regarding your liver. If you consume more than 4,000 mg of acetaminophen in a 24-hour period, especially when combined with other medications that also contain acetaminophen, you may risk severe liver damage. Additionally, drinking three or more alcoholic beverages daily while using this product can further increase this risk. It's crucial to be mindful of these limits to protect your liver health.

Warnings and Precautions

It's important to be aware of the potential risks associated with this product, especially regarding liver health. This product contains acetaminophen, and you should not exceed 6 caplets (3,000 mg) in a 24-hour period. Taking more than 4,000 mg of acetaminophen in 24 hours, especially when combined with other medications containing acetaminophen or if you consume 3 or more alcoholic drinks daily, can lead to severe liver damage.

If you suspect an overdose, it’s crucial to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Quick action is essential, even if you don’t notice any symptoms. Always prioritize your health and safety when using medications.

Overdose

Taking too much of this product, which contains acetaminophen, can lead to serious health issues, particularly severe liver damage. The maximum safe dose is 6 caplets (3,000 mg) in a 24-hour period. If you exceed 4,000 mg of acetaminophen in one day, you risk harming your liver. Be cautious if you are also taking other medications that contain acetaminophen, as this can increase your risk of liver damage.

If you regularly consume 3 or more alcoholic drinks each day while using this product, you should be aware that this can also heighten the risk of liver damage. Signs of an overdose may include nausea, vomiting, loss of appetite, confusion, or jaundice (yellowing of the skin or eyes). If you suspect an overdose or experience any of these symptoms, seek immediate medical attention. It's always better to be safe and consult a healthcare professional if you have any concerns.

Pregnancy Use

While there is no specific information available about the use of APINOPHEN EXTRA STRENGTH (acetaminophen) during pregnancy, it is important to approach any medication with caution. Since the drug insert does not provide details on safety concerns, dosage adjustments, or special precautions for pregnant individuals, you should consult your healthcare provider before taking this medication. They can help you weigh the potential benefits and risks based on your individual circumstances. Always prioritize open communication with your doctor regarding any medications you consider during pregnancy.

Lactation Use

When it comes to breastfeeding, it's important to be aware that there are no specific guidelines or statements regarding nursing mothers or lactation (the process of producing milk). This means that if you are breastfeeding, you may not find detailed information about how certain medications or treatments could affect you or your baby.

If you have concerns about breastfeeding while taking any medication, it's always best to consult with your healthcare provider for personalized advice and to ensure the safety of both you and your infant.

Pediatric Use

If you are considering this medication for your child, it's important to consult a doctor if your child is under 12 years old. For children aged 12 and older, the recommended dosage is 2 caplets every 6 hours as needed for symptoms, but they should not exceed 6 caplets in a 24-hour period unless a doctor advises otherwise. Additionally, this medication should not be used for more than 10 days without a doctor's guidance.

Be aware that if an overdose occurs, it is crucial to seek medical help immediately, even if there are no noticeable symptoms. Keeping these guidelines in mind will help ensure the safe use of this medication for your child.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s always a good idea to discuss any medications with a healthcare provider, especially since older adults may have different health needs and may be taking other medications.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider can help determine the best approach for you, considering your overall health and any other medications you may be taking. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations for patients with renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

Hepatic Impairment

If you have liver problems, it's important to be cautious when using products that contain acetaminophen. The maximum daily dose for this product is 6 caplets, which equals 3,000 mg in 24 hours. Taking more than 4,000 mg of acetaminophen in a day, especially if you are also using other medications that contain acetaminophen or consuming 3 or more alcoholic drinks daily, can lead to severe liver damage.

To protect your liver, make sure to follow these guidelines closely. Always check the total amount of acetaminophen you are taking from all sources and avoid exceeding the recommended dose. If you have any concerns or questions about your liver health and medication use, please consult your healthcare provider for personalized advice.

Drug Interactions

It's important to be aware of potential interactions when taking medications. For instance, if you take more than 4,000 mg of acetaminophen in a 24-hour period, especially with other products that also contain acetaminophen, you could risk severe liver damage. Additionally, consuming three or more alcoholic drinks daily while using this product can also pose serious health risks.

Always discuss any medications you are taking, including over-the-counter drugs and alcohol consumption, with your healthcare provider. They can help you understand the risks and ensure your treatment is safe and effective.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature, ideally between 20°C to 25°C (68°F to 77°F). It's important to keep the product protected from light and to store it in a tightly closed container to maintain its effectiveness. Once you open the container, please remember to discard any unused product to avoid potential contamination or degradation. Following these guidelines will help you use the product safely and effectively.

Additional Information

You will take this medication orally. There are no additional details available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences. If you have any questions or concerns about your treatment, be sure to discuss them with your healthcare provider.

FAQ

What does this drug temporarily relieve?

This drug temporarily relieves minor aches and pains due to the common cold, headache, backache, minor pain of arthritis, toothache, muscular aches, and premenstrual and menstrual cramps. It also temporarily reduces fever.

What is the recommended dosage for adults and children 12 years and over?

Adults and children 12 years and over should take 2 caplets every 6 hours while symptoms last, without exceeding 6 caplets in 24 hours unless directed by a doctor.

What should I do if I suspect an overdose?

In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Quick medical attention is critical for both adults and children.

Are there any liver warnings associated with this drug?

Yes, this product contains acetaminophen. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours or consume 3 or more alcoholic drinks daily while using this product.

Can children under 12 years use this drug?

Children under 12 years should ask a doctor before use.

How should I store this drug?

Store at room temperature, between 20°C to 25°C (68°F to 77°F), protect from light, and keep in a tightly closed container. Discard after opening.

Is there any information regarding use during pregnancy?

There is no specific information regarding the safety or dosage modifications for use during pregnancy in the provided text.

What should I do if I experience severe side effects?

If you experience severe side effects, stop taking the drug and consult your doctor immediately.

Packaging Info

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

Packaging configurations for Apinophen.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

It appears that there are no extracted facts provided for the description section. Please provide the relevant details or data points about the drug, and I will assist you in creating a concise "Description" section.

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 instructed to take 2 caplets every 6 hours as needed while symptoms persist. It is essential that the caplets are swallowed whole; they should not be crushed, chewed, or dissolved to ensure proper absorption and efficacy.

The maximum dosage should not exceed 6 caplets 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, consultation with a healthcare provider is recommended prior to administration.

Contraindications

There are no specified contraindications for the use of this product. Healthcare professionals should exercise clinical judgment and consider individual patient circumstances when prescribing.

Warnings and Precautions

This product contains acetaminophen, which necessitates careful monitoring of dosage to prevent severe liver damage. The maximum recommended daily dose is 6 caplets (3,000 mg) within a 24-hour period. It is critical to note that taking more than 4,000 mg of acetaminophen in 24 hours, particularly in conjunction with other medications containing acetaminophen or while consuming three or more alcoholic beverages daily, significantly increases the risk of liver injury.

In the event of an overdose, immediate medical assistance is essential. Healthcare professionals should advise patients to seek medical help or contact a Poison Control Center at 1-800-222-1222 without delay. Prompt intervention is crucial for both adults and children, even if no symptoms are immediately apparent.

No specific laboratory tests are recommended for monitoring the use of this product; however, healthcare providers should remain vigilant regarding the potential for acetaminophen-related hepatotoxicity, especially in patients with pre-existing liver conditions or those consuming alcohol regularly.

Side Effects

Severe liver damage may occur in patients who exceed a dosage of 4,000 mg of acetaminophen within a 24-hour period, particularly when taken in conjunction with other medications containing acetaminophen or when consuming three or more alcoholic beverages daily while using this product. It is crucial for patients to adhere to the recommended dosage guidelines to mitigate the risk of serious hepatic injury.

Drug Interactions

Severe liver damage may occur if the total daily dosage of acetaminophen exceeds 4,000 mg, particularly when used concurrently with other medications containing acetaminophen. It is advised that healthcare professionals monitor patients for signs of liver toxicity in such cases.

Additionally, the consumption of three or more alcoholic drinks per day should be avoided while using this product, as it may exacerbate the risk of liver damage.

No specific laboratory test interactions have been identified in the available data.

Packaging & NDC

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

Packaging configurations for Apinophen.
Details

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 caplets every 6 hours as needed, with a maximum of 6 caplets in a 24-hour period, unless otherwise directed by a physician. It is advised not to exceed a duration of 10 days of use without medical guidance.

Healthcare providers should be aware of the overdose warning, as prompt medical attention is essential for both adults and pediatric patients, even in the absence of noticeable signs or symptoms.

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

There is no specific information available regarding the use of APINOPHEN EXTRA STRENGTH (acetaminophen) during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when advising pregnant patients. Given the absence of established risk categories or known fetal impacts, the decision to use this medication in pregnant patients should be made on a case-by-case basis, weighing the potential benefits against any unknown risks. Women of childbearing potential should be counseled accordingly.

Lactation

There are no specific statements regarding the use of this medication in nursing mothers or its effects on lactation. Additionally, there is no available data on the excretion of this medication in breast milk or its potential effects on breastfed infants. Healthcare professionals should consider the absence of information when advising lactating mothers about the use of this medication.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data 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 lack of information 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 patients is limited to 6 caplets (3,000 mg) within a 24-hour period. It is critical to note that severe liver damage may occur if the total daily intake of acetaminophen exceeds 4,000 mg, particularly when combined with other medications containing acetaminophen or when the patient consumes 3 or more alcoholic drinks daily while using this product. Therefore, healthcare providers should exercise caution and consider dosage adjustments for patients with compromised liver function to mitigate the risk of hepatotoxicity. Regular assessment of liver function may be warranted in these patients to ensure safety and efficacy.

Overdosage

In the event of an overdosage, it is critical to recognize the potential risks associated with the active ingredient, acetaminophen. The maximum recommended daily dose of this product is 6 caplets, equating to 3,000 mg within a 24-hour period. Exceeding this dosage can lead to severe liver damage, particularly if the total intake of acetaminophen surpasses 4,000 mg in a single day.

Healthcare professionals should be aware that the risk of severe liver damage is compounded when acetaminophen is taken concurrently with other medications that also contain acetaminophen. This necessitates careful review of a patient's medication history to prevent unintentional overdose.

Additionally, the consumption of three or more alcoholic beverages daily while using this product significantly increases the risk of liver damage. It is advisable for healthcare providers to counsel patients on the dangers of alcohol consumption during treatment with acetaminophen-containing products.

In cases of suspected overdosage, immediate medical attention is warranted. Management may include the administration of activated charcoal if the ingestion occurred within a suitable timeframe, as well as monitoring liver function tests and considering the use of N-acetylcysteine as an antidote, depending on the severity of the overdose and the time elapsed since ingestion.

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 use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients on the importance of seeking immediate medical assistance in the event of an overdose. Patients should be informed to contact a Poison Control Center at 1-800-222-1222 without delay. It is crucial to emphasize that prompt medical attention is necessary for both adults and children, even if they do not exhibit any signs or symptoms of overdose. This proactive approach can significantly impact the outcome in such situations.

Storage and Handling

The product is supplied in a tightly closed container to ensure its integrity. It should be stored at room temperature, specifically within the range of 20°C to 25°C (68°F to 77°F). It is essential to protect the product from light exposure to maintain its efficacy. Once opened, the product must be discarded to ensure safety and effectiveness.

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 Apinophen, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Apinophen, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

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Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.