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Dolofin

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This product has been discontinued

Active ingredient
Acetaminophen 325 mg
Other brand names
Dosage form
Tablet
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2017
Label revision date
October 24, 2017
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Acetaminophen 325 mg
Other brand names
Dosage form
Tablet
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2017
Label revision date
October 24, 2017
Manufacturer
Menper Distributors Inc.
Registration number
part343
NDC root
53145-420
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

Dolofin is a medication designed to provide temporary relief from minor aches and pains. It can help alleviate discomfort associated with various conditions, including headaches, muscular aches, minor arthritis pain, menstrual cramps, backaches, toothaches, and symptoms of the common cold. Additionally, Dolofin can temporarily reduce fever, making it a versatile option for managing everyday discomfort.

Uses

You can use this medication for the temporary relief of minor aches and pains. It can help with headaches, muscular aches, minor arthritis pain, menstrual cramps, backaches, toothaches, and discomfort from the common cold. Additionally, it can temporarily reduce fever, providing you with some comfort when you're not feeling well.

This medication is designed to address these common issues, helping you manage pain and discomfort effectively.

Dosage and Administration

When using this medication, it's important to follow the recommended dosage to ensure your safety. For adults and children aged 12 years and older, you can take 1 tablet every 4 to 6 hours as needed, but make sure not to exceed 6 tablets in a 24-hour period. If you have any questions or concerns, it's always best to consult with your doctor.

If you are considering this medication for children under 12 years old, please do not use this adult extra strength product. It contains a higher dose of acetaminophen, which can lead to an overdose and potentially cause serious liver damage. Always prioritize safety and consult a healthcare professional for appropriate alternatives for younger children.

What to Avoid

It's important to keep this medication and all other drugs out of the reach of children to prevent accidental ingestion. If you suspect an overdose, seek medical assistance immediately or contact a Poison Control Center for help. Always prioritize safety when using any medication.

Side Effects

If you are considering using a product that contains acetaminophen, it's important to be aware of potential side effects and warnings. Taking more than 6 tablets in 24 hours, using it with other medications that also contain acetaminophen, or consuming 3 or more alcoholic drinks daily can lead to severe liver damage. If you have liver disease or are on blood thinners like warfarin, consult your doctor before use.

You should not use this product if you are allergic to acetaminophen or any of its ingredients, or if you plan to take it for more than 10 days for pain or more than 3 days for fever without medical advice. If your symptoms do not improve, worsen, or if you notice new symptoms or signs of redness or swelling, stop using the product and seek medical attention, as these may indicate a serious condition.

Warnings and Precautions

If you drink three or more alcoholic beverages each day, it's important to talk to your doctor before taking acetaminophen or other pain relievers, as acetaminophen can lead to liver damage. Be cautious with this medication, as taking more than six tablets in 24 hours, using it alongside other products containing acetaminophen, or consuming alcohol can significantly increase the risk of severe liver damage.

You should not use this product if you are allergic to acetaminophen or any of its ingredients, or if you are taking other medications that contain acetaminophen. Additionally, avoid using it for more than 10 days for pain or more than 3 days for fever unless directed by a doctor. If you have liver disease or are on the blood thinner warfarin, consult your doctor before use.

If your symptoms do not improve, if pain or fever persists or worsens, or if you notice new symptoms or signs of redness or swelling, stop using the product and contact your doctor. In case of an overdose, seek emergency medical help immediately or call Poison Control at 1-800-222-1222, as prompt attention is crucial for both adults and children.

Overdose

Taking too much of this product, which contains acetaminophen, can lead to serious liver damage. You should be cautious not to exceed 6 tablets in a 24-hour period, as this is the maximum daily amount. Additionally, avoid combining this product with other medications that also contain acetaminophen, and limit your alcohol intake to less than 3 drinks per day to reduce the risk of overdose.

If you suspect an overdose, look out for signs such as nausea, vomiting, loss of appetite, confusion, or jaundice (yellowing of the skin or eyes). It’s important to seek immediate medical help if you experience any of these symptoms or if you believe you have taken too much of the medication. Always prioritize your health and safety by consulting a healthcare professional if you have any concerns.

Pregnancy Use

If you are pregnant or nursing, it’s important to consult with a healthcare professional before using this product. They can provide guidance tailored to your specific situation, ensuring both your health and the health of your baby are prioritized. Always prioritize open communication with your doctor about any medications you are considering during this time.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult with a healthcare professional before using this product. They can provide guidance on any potential effects it may have on your milk production or your baby. Always prioritize your health and your baby's well-being by seeking expert advice.

Pediatric Use

It's important to be cautious when giving medications to children. If your child is under 12 years old, you should not use this adult extra strength product, as it can lead to an overdose of acetaminophen, which may harm their liver.

For adults and children aged 12 and older, the recommended dosage is one tablet every 4 to 6 hours as needed, or as directed by a doctor. If you suspect an overdose, seek medical help immediately, even if there are no noticeable symptoms. Always prioritize safety when it comes to medication for your children.

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. Since older adults may have different health needs and may be taking multiple medications, it’s always a good idea to consult with a healthcare provider before starting any new medication. They can help ensure that the treatment is safe and appropriate for your individual health situation.

If you or a loved one is an older adult, be sure to discuss any concerns about potential side effects or interactions with other medications you may be taking. Your healthcare provider can provide guidance tailored to your specific needs.

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 related to 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 disease, it's important to consult your doctor before using this product. It contains acetaminophen, which can be harmful to your liver. Taking more than 6 tablets in a 24-hour period is the maximum safe amount. Be cautious, as severe liver damage can occur if you exceed this limit, especially if you are also using other medications that contain acetaminophen or if you consume 3 or more alcoholic drinks each day. Always prioritize your liver health and follow your healthcare provider's advice.

Drug Interactions

It's important to talk to your healthcare provider before using this medication, especially if you are taking warfarin, a blood-thinning drug. Combining these medications can increase the risk of bleeding, which can be serious. Always keep your doctor informed about all the medications you are taking to ensure your safety and the effectiveness of your treatment.

Storage and Handling

To ensure the safety and effectiveness 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 it protected from light to maintain its quality. Always remember to keep this product, as well as all medications, out of the reach of children to prevent accidental ingestion. Once you open the product, be sure to discard it, as it should not be reused. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should take this medication orally, with adults and children aged 12 and over advised to take 1 tablet every 4-6 hours as needed, or as directed by a doctor. However, this extra strength product is not suitable for children under 12 years of age.

If you are pregnant or nursing, it's important to consult with a healthcare professional before using this product to ensure it's safe for you and your baby.

FAQ

What is dolofin used for?

Dolofin is used for the temporary relief of minor aches and pains associated with headaches, muscular aches, minor arthritis pain, menstrual cramps, common cold, backaches, toothaches, and it temporarily reduces fever.

What is the maximum dosage of dolofin?

You should not take more than 6 tablets in 24 hours.

How should adults and children over 12 take dolofin?

Adults and children 12 years and over should take 1 tablet every 4-6 hours as needed, or as directed by a doctor.

Can children under 12 use dolofin?

No, children under 12 years should not use this adult extra strength product as it may lead to an overdose of acetaminophen.

What should I do in case of an overdose?

In case of overdose, get medical help or contact a Poison Control Center right away.

Are there any warnings associated with dolofin?

Yes, if you consume 3 or more alcoholic drinks daily, consult your doctor before taking dolofin, as it may cause liver damage.

What should I do if my symptoms do not improve?

Stop using dolofin and ask a doctor if your symptoms do not improve, if pain or fever persists or worsens, or if new symptoms occur.

Is dolofin safe to use during pregnancy or while nursing?

You should seek the advice of a health professional before using dolofin if you are pregnant or nursing.

How should dolofin be stored?

Store dolofin at room temperature, between 20°C to 25°C (68°F to 77°F), and protect it from light.

Packaging Info

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

Packaging configurations for Dolofin.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Dolofin is a pharmaceutical compound characterized by its specific chemical properties. The molecular weight of dolofin is not specified in the provided data. The chemical formula is also not detailed. Dolofin is available in a dosage form suitable for its intended therapeutic use. The appearance of dolofin has not been described in the provided information. Further details regarding its inactive ingredients and specific formulation characteristics are not included.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, muscular aches, minor arthritis pain, menstrual cramps, common cold, backaches, and toothaches. 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 1 tablet every 4 to 6 hours as needed, or as directed by a healthcare professional. The maximum allowable dosage is 6 tablets within a 24-hour period.

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 liver damage. Therefore, it is imperative that this product not be administered to children in this age group.

Contraindications

There are no specific contraindications identified for this product. However, it is essential to keep this and all medications out of the reach of children to prevent accidental ingestion. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients to be cautious regarding the following warnings and precautions.

Alcohol Consumption Patients who consume three or more alcoholic drinks daily should consult their healthcare provider before taking acetaminophen or any other pain relievers or fever reducers, as this may increase the risk of liver damage.

Liver Damage Risk The maximum recommended dosage is six tablets within a 24-hour period. Patients must be cautioned against exceeding this limit, using other medications containing acetaminophen concurrently, or consuming three or more alcoholic drinks daily, as these factors significantly elevate the risk of severe liver damage.

Contraindications This product should not be used in conjunction with any other medications containing acetaminophen, whether prescription or over-the-counter. Patients should be advised to consult a healthcare professional if they are uncertain about the acetaminophen content of any medication. Additionally, individuals with a known allergy to acetaminophen or any inactive ingredients in the product should avoid its use. The product is not recommended for use beyond 10 days for pain or three days for fever unless directed by a healthcare provider.

Consultation Prior to Use Patients should seek medical advice before using this product if they have a history of liver disease or are currently taking the anticoagulant warfarin.

Monitoring and Discontinuation Patients are advised to discontinue use and consult a healthcare provider if symptoms do not improve, if pain or fever persists or worsens, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious underlying condition.

Emergency Assistance In the event of an overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help right away, even if no signs or symptoms are apparent. Quick intervention is essential for both adults and children.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this product, particularly those related to liver health and alcohol consumption.

Severe liver damage may occur if patients exceed the maximum recommended dosage of 6 tablets in a 24-hour period, take this product in conjunction with other medications containing acetaminophen, or consume 3 or more alcoholic drinks daily. It is crucial for patients to consult with a healthcare provider if they regularly consume alcohol or have liver disease before using this product.

Patients are advised not to use this product if they are allergic to acetaminophen or any of the inactive ingredients. Additionally, it should not be used for more than 10 days for pain or more than 3 days for fever unless directed by a healthcare professional.

Participants should discontinue use and seek medical advice if symptoms do not improve, if pain or fever persists or worsens, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious condition.

It is recommended that patients ask a doctor before using this product if they are taking the blood-thinning medication warfarin, as interactions may occur.

Drug Interactions

Patients taking the anticoagulant warfarin should consult a healthcare professional prior to initiating treatment with this medication. The interaction between this drug 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 warfarin may be required based on the clinical judgment of the healthcare provider.

Packaging & NDC

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

Packaging configurations for Dolofin.
Details

Pediatric Use

Children under 12 years of age should not use this adult extra strength product, as it may result in an overdose of acetaminophen, potentially leading to liver damage. Quick medical attention is essential for both adults and children in the event of an overdose, even if no signs or symptoms are immediately apparent.

For pediatric patients aged 12 years and older, the recommended dosage is 1 tablet every 4-6 hours as needed, or as directed by a healthcare professional.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

Pregnant patients and those nursing a baby should seek the advice of a healthcare professional before using this product. The safety of this medication during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. Therefore, it is essential for women of childbearing potential to discuss their individual circumstances with a healthcare provider to weigh the benefits and risks associated with the use of this product during pregnancy and lactation.

Lactation

Lactating mothers are advised to seek the advice of a health professional before using this product. There is no specific data available regarding the excretion of this drug in breast milk or its effects on breastfed infants. Therefore, healthcare providers should carefully consider the potential risks and benefits when recommending this product to nursing mothers.

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.

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 associated with acetaminophen, which is a component of this formulation.

It is critical to note that severe liver damage may occur if patients exceed the maximum recommended dosage of 6 tablets within a 24-hour period. This risk is further heightened when acetaminophen is taken in conjunction with other medications containing acetaminophen or when patients consume 3 or more alcoholic beverages daily.

Due to these considerations, careful monitoring of liver function and adherence to recommended dosing guidelines is essential for patients with compromised liver function.

Overdosage

Severe liver damage may occur following an overdose of this product, which contains acetaminophen. Healthcare professionals should be aware of the following critical points regarding overdosage.

Maximum Daily Dosage The maximum recommended dosage is 6 tablets within a 24-hour period. Exceeding this limit significantly increases the risk of liver injury.

Concurrent Use with Other Acetaminophen Products Patients should be cautioned against the simultaneous use of this product with other medications that also contain acetaminophen. Such combinations can lead to cumulative dosages that exceed safe limits, heightening the risk of hepatotoxicity.

Alcohol Consumption The consumption of 3 or more alcoholic drinks daily while using this product can exacerbate the potential for liver damage. It is essential to advise patients to limit alcohol intake to mitigate this risk.

Recommended Actions In the event of suspected overdosage, immediate medical attention is warranted. Healthcare providers should assess the patient's condition and consider the administration of activated charcoal if the overdose is recent. Monitoring liver function tests and providing supportive care are critical components of management. In cases of severe overdose, the use of N-acetylcysteine as an antidote may be indicated to prevent or mitigate liver damage.

Healthcare professionals are encouraged to remain vigilant regarding the signs and symptoms of acetaminophen overdose, which may include nausea, vomiting, loss of appetite, confusion, and jaundice. Early recognition and intervention are vital to improving patient outcomes.

Nonclinical Toxicology

Pregnant or nursing individuals are advised to consult a health professional prior to using this product, as teratogenic effects may be a concern. No specific non-teratogenic effects or detailed nonclinical toxicology information have been provided. Additionally, there are no specific findings related to animal pharmacology and toxicology available in the current data.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication and all other drugs out of the reach of children to prevent accidental ingestion.

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

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature, maintaining a range of 20°C to 25°C (68°F to 77°F).

To ensure the integrity of the product, it must be protected from light exposure. Additionally, it is crucial to keep this and all medications out of the reach of children to prevent accidental ingestion. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

The product is administered orally. For adults and children aged 12 years and older, the recommended dosage is one tablet every 4 to 6 hours as needed, or as directed by a healthcare professional. It is important to note that this adult extra strength product should not be used in children under 12 years of age.

Clinicians should advise patients to consult a health professional if they are pregnant or nursing before using this product. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Dolofin, 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 Dolofin, 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.

Learn more in our Editorial Policy

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Primary FDA sources:

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.