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Citramon

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This product has been discontinued

Active ingredients
  • Aspirin 220 mg/550 mg
  • Acetaminophen 200 mg/550 mg
  • Caffeine 27 mg/550 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 1996
Label revision date
August 24, 2016
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Aspirin 220 mg/550 mg
  • Acetaminophen 200 mg/550 mg
  • Caffeine 27 mg/550 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 1996
Label revision date
August 24, 2016
Manufacturer
Borisovskiy Zavod Medicinskikh Preparatov JSC
Registration number
part343
NDC root
16638-118
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

This medication is effective in relieving mild to moderate pain, which can include headaches, migraines, toothaches, and pain associated with conditions like osteoarthritis and arthritis. It is also used to alleviate menstrual pain (algodismenorrhea), lower back pain (lumbago), sciatica, and other types of muscle and nerve pain (neuralgia and myalgia). Additionally, it can help reduce fever during acute infections and inflammatory diseases.

Uses

You can use this medication to help relieve mild to moderate pain from various conditions, such as headaches, migraines, toothaches, and pain associated with osteoarthritis and arthritis. It is also effective for menstrual pain (dysmenorrhea), lower back pain (lumbago), sciatica, and other types of muscle and nerve pain, including myalgia and neuralgia. Additionally, this medication can help reduce fever caused by acute infections or inflammatory diseases.

It's important to note that there are no reported teratogenic effects (which means it does not cause birth defects) or nonteratogenic effects associated with this medication. This makes it a safer option for managing pain and fever in many situations.

Dosage and Administration

When taking this medication, you should follow a specific dosage schedule to ensure it works effectively. For adults and children over 15 years old, the recommended dose is 1 tablet taken 2 to 3 times a day. It's important to space out your doses, so make sure there is at least a 6 to 8-hour interval between each tablet.

Keep in mind that the maximum amount you can take at one time is 2 tablets, and you should not exceed a total of 4 tablets in one day. Following these guidelines will help you use the medication safely and effectively.

What to Avoid

There are no specific contraindications, controlled substance classifications, or risks of abuse, misuse, or dependence associated with this medication. This means that, based on the available information, there are no known reasons to avoid using it, and it does not fall under any controlled substance regulations.

However, it's always important to consult with your healthcare provider before starting any new medication to ensure it is appropriate for your individual health needs. If you have any concerns or questions about this medication, please reach out to your doctor for guidance.

Side Effects

If you notice that your condition worsens or does not improve after using this product as directed, it's important to stop using it and consult a doctor. Even if you don't see any signs or symptoms, seeking prompt medical attention is crucial. Your health and safety are the top priority, so don't hesitate to reach out for help if needed.

Warnings and Precautions

If you are using this product, it's important to monitor your condition closely. If your symptoms worsen or do not improve after using the product as directed, stop using it and consult your doctor. Even if you feel fine, seek medical attention promptly if you experience an accidental overdose, or contact a Poison Control center for immediate assistance.

Additionally, always be aware of how your body is responding to the treatment. If you notice any changes or have concerns, don’t hesitate to reach out to your healthcare provider for guidance. Your health and safety are the top priority.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get checked by a healthcare professional if you have any concerns about your health. Remember, timely intervention can make a significant difference.

Pregnancy Use

The safety of this product during pregnancy has not been established, and it is contraindicated, meaning it should not be used while pregnant due to potential risks to your baby. Using aspirin during pregnancy may lead to serious complications, including fetal bleeding and premature closure of a vital blood vessel called the ductus arteriosus.

If you are pregnant or planning to become pregnant, it is essential to consult your healthcare provider before using this product. They can help you understand the risks and determine the best course of action for your health and the health of your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

When it comes to using this medication for children, it's important to note that it is not recommended for those under 15 years of age. For adults and children over 15, the typical dosage is 1 tablet taken 2 to 3 times a day, with at least 6 to 8 hours between doses. The maximum single dose is 2 tablets, and you should not exceed 4 tablets in a day.

Always keep this medication out of reach of younger children. If a child accidentally takes too much, seek medical help or contact a Poison Control center right away. Your vigilance is key to ensuring their safety.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that healthcare providers may not have tailored guidelines for elderly patients.

If you or a loved one is an older adult considering this medication, it’s important to discuss any potential risks and benefits with your healthcare provider. They can help determine the best approach based on individual health needs and circumstances. Always prioritize open communication about any concerns you may have regarding medication use.

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 standard recommendations for the medication do not include special monitoring or safety considerations tailored for patients with renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific health needs. They can provide guidance based on your kidney function and overall health.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.

Drug Interactions

It's important to be aware that some common medications can interact with each other, which may affect your health. For instance, taking aspirin alongside blood thinners (anticoagulants) can increase your risk of bleeding. Similarly, if you use acetaminophen with warfarin, another blood thinner, this could also heighten bleeding risks. Additionally, caffeine can amplify the effects of certain stimulant medications, so it's wise to discuss your caffeine intake with your healthcare provider.

Moreover, some medications can interfere with laboratory tests. Aspirin may affect blood glucose and uric acid tests, potentially leading to inaccurate results. Acetaminophen can influence liver function tests, causing elevated liver enzyme levels. Always talk to your healthcare provider about any medications you are taking and any lab tests you may need, as this will help ensure your safety and the accuracy of your test results.

Storage and Handling

To ensure the best performance and safety of your product, store it in a dry place where the temperature remains below 77 ºF (25 ºC). This helps maintain its effectiveness and prevents any potential damage.

When handling the product, make sure to do so with clean hands and in a sterile field (a clean area free from germs) to avoid contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal of any components.

Additional Information

You should take this medication orally, with adults and children over 15 years old typically taking 1 tablet 2 to 3 times a day. Make sure to space out the doses by at least 6 to 8 hours. The maximum single dose is 2 tablets, and you should not exceed 4 tablets in a day. If you have any questions about your treatment or how to take this medication, consult your healthcare provider for guidance.

FAQ

What types of pain is this medication effective for?

This medication is effective for mild to moderate intensity pain, including headaches, migraines, toothaches, and pain from osteoarthritis, arthritis, and other conditions.

What is the recommended dosage for adults and children over 15 years?

Adults and children over 15 years should take 1 tablet 2 to 3 times a day, with an interval of at least 6 to 8 hours between doses.

What is the maximum daily dose of this medication?

The maximum daily dose is 4 tablets, and the maximum single dose is 2 tablets.

Are there any contraindications for this medication?

There are no contraindications listed, but it is contraindicated in pregnancy due to potential risks to the fetus.

What should I do if my condition worsens while using this medication?

You should stop use and ask a doctor if your condition worsens or does not improve after regular use as directed.

Is this medication safe to use during pregnancy?

The safety of this medication during pregnancy has not been established, and it may pose risks such as fetal bleeding.

What should I do in case of an accidental overdose?

In case of accidental overdose, get medical help or contact a Poison Control center immediately.

Can this medication interact with other drugs?

Yes, this medication may interact with anticoagulants and other medications, increasing the risk of bleeding.

How should this medication be stored?

Keep this medication in a dry place at a temperature below 77 ºF (25 ºC) and out of reach of children.

Packaging Info

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

Packaging configurations for Citramon.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No relevant information is available for SPL code 34089-3.

Uses and Indications

This drug is indicated for the relief of mild to moderate intensity pain, including but not limited to headache, migraine, toothache, pain associated with osteoarthritis, arthritis, menalgia, algodismenorrhea, lumbago, sciatica, osteochondrosis, neuralgia, and myalgia. Additionally, it is effective in managing fever associated with acute infectious and infectious inflammatory diseases.

There are no teratogenic or nonteratogenic effects reported with the use of this drug.

Dosage and Administration

Adults and children over 15 years of age are advised to take 1 tablet 2 to 3 times daily. The intervals between doses should be maintained at a minimum of 6 to 8 hours to ensure optimal therapeutic effect.

The maximum single dose should not exceed 2 tablets, and the total daily dosage must not surpass 4 tablets. Careful adherence to these dosing guidelines is essential to avoid potential adverse effects and to ensure the safe and effective use of the medication.

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

Patients should discontinue use of this product and consult a healthcare professional if their condition worsens or fails to improve after consistent application as directed. It is essential to seek prompt medical attention, even in the absence of noticeable signs or symptoms, as this may indicate a more serious underlying issue.

In the event of an accidental overdose, immediate medical assistance is required. Patients or caregivers should contact a Poison Control center or seek emergency medical help without delay.

Healthcare professionals are advised to monitor patients closely and encourage them to report any adverse effects or lack of improvement in their condition. Regular follow-up assessments may be necessary to ensure the safe and effective use of this product.

Side Effects

Patients should be advised to discontinue use of the product and consult a healthcare professional if their condition worsens or does not improve after regular use as directed. It is essential for patients to seek prompt medical attention, even in the absence of noticeable signs or symptoms, to ensure appropriate management of any potential adverse reactions.

Drug Interactions

Aspirin has been identified to interact with anticoagulants, which may lead to an increased risk of bleeding. Healthcare professionals should monitor patients closely for signs of bleeding and consider dosage adjustments as necessary.

Acetaminophen may also interact with warfarin, potentially heightening the risk of bleeding. It is advisable to monitor coagulation parameters in patients receiving both medications and adjust dosages accordingly to mitigate this risk.

Caffeine has the potential to enhance the effects of certain medications, particularly stimulants. Clinicians should be aware of this interaction and consider the cumulative effects when prescribing stimulant medications alongside caffeine.

In terms of laboratory test interactions, aspirin may interfere with specific tests, including blood glucose and uric acid tests, which could result in false results. Clinicians should take this into account when interpreting laboratory findings in patients taking aspirin.

Acetaminophen may impact liver function tests, potentially leading to elevated liver enzyme levels. Regular monitoring of liver function is recommended for patients on acetaminophen, especially those with pre-existing liver conditions or those taking other hepatotoxic medications.

Packaging & NDC

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

Packaging configurations for Citramon.
Details

Pediatric Use

Pediatric patients over 15 years of age may take 1 tablet 2 to 3 times daily, with a minimum interval of 6 to 8 hours between doses. The maximum single dose for this age group is 2 tablets, and the maximum daily dose is 4 tablets.

It is important to keep this medication out of reach of children. In the event of an accidental overdose, immediate medical assistance should be sought, or contact a Poison Control center.

Geriatric Use

There is no specific information 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

The safety of this product during pregnancy has not been established. This product is contraindicated in pregnancy due to potential risks to the fetus. The use of aspirin during pregnancy may be associated with risks such as fetal bleeding, premature closure of the ductus arteriosus, and other complications. Pregnant women should consult a healthcare provider before using this product to discuss potential risks and alternative treatment options.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available concerning the potential for excretion in breast milk or any associated risks to breastfed infants.

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 have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and consider general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care and symptomatic treatment as necessary. This may include monitoring vital signs, providing respiratory support, and administering intravenous fluids if indicated.

Additionally, healthcare professionals should consult local poison control centers or relevant toxicology resources for guidance on specific management protocols tailored to the substance involved.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective management and follow-up care.

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

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is important for patients to understand the potential risks associated with overdose. In the event of an accidental overdose, patients should be instructed to seek medical help or contact a Poison Control center immediately. This information is crucial for ensuring patient safety and promoting responsible use of the medication.

Storage and Handling

The product is supplied in a configuration that ensures optimal quality and efficacy. It should be stored in a dry place, maintaining a temperature below 77 ºF (25 ºC) to preserve its integrity. Proper storage conditions are essential to prevent degradation and ensure the product remains effective for its intended use.

Additional Clinical Information

The medication is administered orally. For adults and children over 15 years, the recommended dosage is 1 tablet taken 2 to 3 times daily, with a minimum interval of 6 to 8 hours between doses. The maximum single dose is 2 tablets, and the maximum daily dose is 4 tablets.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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