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Rapidol Aspirin

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Active ingredient
Aspirin 325 mg
Other brand names
Drug classes
Nonsteroidal Anti-inflammatory Drug, Platelet Aggregation Inhibitor
Dosage form
Tablet, Coated
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2023
Label revision date
July 14, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Aspirin 325 mg
Other brand names
Drug classes
Nonsteroidal Anti-inflammatory Drug, Platelet Aggregation Inhibitor
Dosage form
Tablet, Coated
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 2023
Label revision date
July 14, 2025
Manufacturer
Pharmadel LLC
Registration number
M013
NDC root
55758-363
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

PDP RAPIDOL ASPIRIN is a medication designed to provide temporary relief from minor aches and pains. You can use it for various discomforts, including those caused by a cold, headaches, backaches, muscular aches, toothaches, and minor pains associated with arthritis. This medication works by targeting the sources of pain, helping you feel more comfortable during those times when you need it most.

Uses

You can use this medication for the temporary relief of minor aches and pains caused by various conditions. This includes discomfort from a cold, headaches, backaches, muscular aches, toothaches, and minor arthritis-related pains.

It's important to note that there are no reported teratogenic effects (which means it does not cause birth defects) associated with this medication. This makes it a safer option for those concerned about such risks.

Dosage and Administration

When you need to take this medication, make sure to drink a full glass of water with each dose. For adults and children aged 12 years and older, you can take one or two tablets every four hours as long as your symptoms continue. However, it's important not to exceed 12 tablets in a 24-hour period unless your doctor advises otherwise.

If the patient is a child under 12 years old, it's essential to consult a doctor before giving them this medication. This ensures that the treatment is safe and appropriate for their age and health condition. Always follow these guidelines to use the medication effectively and safely.

What to Avoid

You should avoid using this medication if you have ever experienced an allergic reaction to any other pain reliever or fever reducer. It's important to prioritize your safety and well-being, so if you have a history of such reactions, please do not take this medication. Always consult with your healthcare provider if you have any questions or concerns about your medications.

Side Effects

Using this product may come with some serious risks. If you are a child or teenager recovering from chickenpox or flu-like symptoms, you should avoid it due to the potential for Reye's syndrome, a rare but serious illness. Be aware that aspirin can cause severe allergic reactions, which may include hives, facial swelling, shock, or asthma symptoms like wheezing.

Additionally, this product contains a nonsteroidal anti-inflammatory drug (NSAID), which can lead to severe stomach bleeding, especially if you are over 60, have a history of stomach ulcers, or are taking certain medications like blood thinners or other NSAIDs. If you experience symptoms such as feeling faint, vomiting blood, or having bloody or black stools, seek medical attention immediately. Always consult your doctor if you have asthma, a history of stomach issues, or other health conditions before using this product.

Warnings and Precautions

It's important to be aware of some serious warnings when using this product. If you are a child or teenager recovering from chickenpox or flu-like symptoms, you should not use this product, as it could lead to Reye's syndrome, a rare but serious illness. Additionally, be cautious of potential allergic reactions, which may include hives, facial swelling, shock, or asthma symptoms like wheezing. This product contains a nonsteroidal anti-inflammatory drug (NSAID), which can increase the risk of severe stomach bleeding, especially if you are over 60, have a history of stomach ulcers, or consume alcohol regularly.

Before using this product, consult your doctor if you have asthma, high blood pressure, heart disease, liver cirrhosis, kidney disease, or if you take diuretics or other medications for diabetes, gout, or arthritis. If you experience any signs of an allergic reaction or stomach bleeding—such as feeling faint, vomiting blood, or having bloody or black stools—stop using the product and seek medical help immediately. In case of an overdose, contact a Poison Control Center or seek emergency medical assistance right away.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately or contact a Poison Control Center. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Don’t wait for symptoms to worsen; getting prompt assistance can be vital. Always prioritize your safety and the safety of others by acting quickly in these situations.

Pregnancy Use

If you are pregnant or breastfeeding, it’s crucial to consult with a healthcare professional before using any medication. This is to ensure the safety of both you and your baby.

Particularly, avoid using aspirin during the last three months of your pregnancy unless your doctor specifically advises you to do so. Taking aspirin at this stage can lead to potential issues for your unborn child or complications during delivery. Always prioritize open communication with your healthcare provider regarding any medications you may consider.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This is particularly crucial if you are considering taking aspirin during the last three months of your pregnancy, as it can potentially lead to issues for your unborn child or complications during delivery. Always prioritize your health and the health of your baby by seeking guidance from your doctor.

Pediatric Use

It's important to be cautious when giving this product to children and teenagers. If your child has or is recovering from chickenpox or flu-like symptoms, they should not use this product, as it could lead to a serious condition called Reye's syndrome. If you notice any changes in your child's behavior along with nausea and vomiting while using this product, contact a doctor immediately, as these could be early signs of this illness.

Additionally, if your child has ever had an allergic reaction to any pain reliever or fever reducer, do not use this product. If your child is experiencing pain from arthritis, it's best to consult a doctor before use. For children under 12 years old, always check with a healthcare professional for guidance on appropriate use and dosage.

Geriatric Use

As you age, it's important to be aware of certain health risks associated with medications. If you are 60 years or older, there is a higher chance of experiencing severe stomach bleeding when taking certain medications. This risk means that you should discuss any new medications with your healthcare provider, who can help you understand the potential side effects and adjust dosages if necessary.

Always keep your doctor informed about your age and any other health conditions you may have, as this information is crucial for safe medication management. Taking precautions can help you avoid complications and ensure that your treatment is both effective and safe.

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication. This is especially crucial if you also have high blood pressure, heart disease, or liver cirrhosis, as these conditions can affect how your body processes the medication. Your healthcare provider can help determine if this treatment is safe for you and whether any adjustments are needed based on your kidney function. Always prioritize open communication with your doctor regarding your health conditions.

Hepatic Impairment

If you have liver problems, such as liver cirrhosis (a severe scarring of the liver), it's important to consult your doctor before using this medication. Your healthcare provider can help determine if it's safe for you, especially if you also have other conditions like high blood pressure or heart disease.

Always prioritize your health by discussing any existing liver issues with your doctor to ensure proper care and monitoring.

Drug Interactions

It's important to be aware that this product contains a nonsteroidal anti-inflammatory drug (NSAID), which can increase the risk of severe stomach bleeding, especially if you are also taking blood thinners (medications that prevent blood clots) or steroids. Additionally, using other NSAIDs, whether prescription or over-the-counter, like aspirin or ibuprofen, can further elevate this risk.

Before starting this medication, make sure to discuss any other prescriptions you are taking, particularly those for diabetes, gout, or arthritis, with your healthcare provider or pharmacist. They can help ensure that your treatment plan is safe and effective, minimizing any potential interactions.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 68-77°F (20-25°C). This temperature range helps maintain the integrity and effectiveness of the device.

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

Additional Information

No further information is available.

FAQ

What is PDP RAPIDOL ASPIRIN used for?

PDP RAPIDOL ASPIRIN is used for the temporary relief of minor aches and pains due to conditions such as a cold, headache, backache, muscular aches, toothache, and minor pains from arthritis.

What should I do if I have an allergic reaction?

If you experience an allergic reaction, seek medical help right away.

Who should not use PDP RAPIDOL ASPIRIN?

Do not use this product if you have ever had an allergic reaction to any other pain reliever or fever reducer.

What are the dosage instructions for adults and children 12 years and older?

Adults and children 12 years and older should take one or two tablets every 4 hours while symptoms persist, and drink a full glass of water with each dose. Do not exceed 12 tablets in 24 hours unless directed by a doctor.

What should children under 12 do?

Consult a doctor before giving PDP RAPIDOL ASPIRIN to children under 12 years of age.

What are the warnings associated with PDP RAPIDOL ASPIRIN?

Warnings include the risk of Reye's syndrome in children recovering from chicken pox or flu-like symptoms, severe allergic reactions, and the potential for stomach bleeding, especially in those over 60 or with certain medical conditions.

What should I do if I experience signs of stomach bleeding?

Stop using the product and call your doctor if you feel faint, vomit blood, have bloody or black stools, or experience stomach pain that does not improve.

Can I use PDP RAPIDOL ASPIRIN if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, consult a health professional before use, especially during the last 3 months of pregnancy.

What should I do if I am taking other medications?

Ask a doctor or pharmacist before use if you are taking prescription drugs for diabetes, gout, or arthritis, or if you have high blood pressure, heart disease, liver cirrhosis, or kidney disease.

How should I store PDP RAPIDOL ASPIRIN?

Store PDP RAPIDOL ASPIRIN between 68-77˚F (20-25˚C).

Packaging Info

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

Packaging configurations for Rapidol Aspirin.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

PDP RAPIDOL ASPIRIN is presented in a dosage form of 60 capsules. The product is identified by the SPL Code 34089-3.

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, muscular aches, toothache, and minor pains resulting from arthritis.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children 12 years of age and older are instructed to take one (1) or two (2) tablets every 4 hours as needed while symptoms persist. Each dose should be accompanied by a full glass of water. It is imperative that patients do not exceed a total of 12 tablets within a 24-hour period unless otherwise directed by a healthcare professional.

For children under 12 years of age, it is recommended to consult a doctor prior to administration to determine the appropriate dosage and administration guidelines.

Contraindications

Use is contraindicated in individuals with a history of allergic reactions to any other pain reliever or fever reducer.

Warnings and Precautions

Children and teenagers who are experiencing or recovering from chickenpox or flu-like symptoms should not use this product due to the risk of Reye's syndrome. If any changes in behavior accompanied by nausea and vomiting occur while using this product, it is imperative to consult a healthcare professional, as these symptoms may indicate the onset of Reye's syndrome, a rare but serious condition.

Aspirin may provoke severe allergic reactions, which can manifest as hives, facial swelling, shock, or asthma symptoms such as wheezing. Healthcare professionals should be vigilant for these signs and advise patients to seek immediate medical attention if they occur.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of this adverse effect is increased in individuals who are 60 years of age or older, have a history of stomach ulcers or bleeding disorders, are taking anticoagulants or steroid medications, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic beverages daily, or exceed the recommended dosage or duration of use.

Healthcare providers should advise patients to consult a physician prior to using this product if they have asthma, if the stomach bleeding warning applies to them, if they have a history of gastrointestinal issues such as heartburn, or if they have conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. Additionally, patients taking diuretics or prescription medications for diabetes, gout, or arthritis should seek guidance from a healthcare professional before use.

In the event of an overdose, it is crucial to obtain emergency medical assistance or contact a Poison Control Center immediately.

Patients should discontinue use and contact their doctor if they experience any signs of an allergic reaction, such as hives or swelling, or if they exhibit symptoms indicative of stomach bleeding, including feeling faint, vomiting blood, passing bloody or black stools, experiencing persistent stomach pain, or noticing ringing in the ears or hearing loss. Furthermore, if pain worsens or persists beyond 10 days, if fever intensifies or lasts more than three days, if redness or swelling occurs, or if any new symptoms arise, patients should seek medical advice promptly.

Side Effects

Patients using this product should be aware of several serious and common adverse reactions associated with its use.

Reye's syndrome is a rare but serious illness that may occur in children and teenagers who have or are recovering from chickenpox or flu-like symptoms. Patients should not use this product under these circumstances. If changes in behavior accompanied by nausea and vomiting occur, it is crucial to consult a healthcare professional, as these may be early signs of Reye's syndrome.

Severe allergic reactions to aspirin can occur, manifesting as hives, facial swelling, shock, or asthma (wheezing). Patients experiencing any signs of an allergic reaction should seek medical attention immediately.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may increase the risk of severe stomach bleeding. The risk is heightened in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid medications, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic drinks daily, or exceed the recommended dosage or duration of use.

Patients should discontinue use and consult a doctor if they experience any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additional symptoms warranting medical consultation include ringing in the ears or loss of hearing, worsening pain lasting more than 10 days, fever lasting more than three days, redness or swelling, or the appearance of any new symptoms.

Before using this product, patients should consult a healthcare professional if they have asthma, a history of stomach problems such as heartburn, high blood pressure, heart disease, liver cirrhosis, or kidney disease. It is also advisable to seek medical advice if taking a diuretic or any prescription medication for diabetes, gout, or arthritis.

Drug Interactions

The presence of a nonsteroidal anti-inflammatory drug (NSAID) in this product may lead to an increased risk of severe gastrointestinal bleeding, particularly in patients concurrently using anticoagulants or steroid medications. Caution is advised when this product is used alongside other NSAIDs, whether prescription or over-the-counter, such as aspirin, ibuprofen, or naproxen, as this may further elevate the risk of adverse effects.

Patients taking prescription medications for diabetes, gout, or arthritis should consult with a healthcare professional prior to using this product. Monitoring for potential interactions and adverse effects is recommended in these cases to ensure patient safety and therapeutic efficacy.

Packaging & NDC

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

Packaging configurations for Rapidol Aspirin.
Details

Pediatric Use

Children and teenagers who have or are recovering from chickenpox or flu-like symptoms should not use this product due to the risk of Reye's syndrome, a rare but serious illness. If changes in behavior accompanied by nausea and vomiting occur while using this product, it is important to consult a doctor, as these may be early signs of Reye's syndrome.

This product should not be used by individuals with a history of allergic reactions to any other pain reliever or fever reducer. Additionally, it is advised to consult a doctor before use in pediatric patients experiencing pain from arthritis.

For children under 12 years of age, it is recommended to consult a doctor prior to use.

Geriatric Use

Elderly patients, particularly those aged 60 and older, may have an increased risk of severe stomach bleeding when using this medication. It is essential for healthcare providers to exercise caution when prescribing this treatment to geriatric patients.

Monitoring for signs of gastrointestinal bleeding is recommended, and dosage adjustments may be necessary based on the individual patient's health status and concurrent medications. Careful assessment of the risks versus benefits should be conducted to ensure the safety of elderly patients receiving this therapy.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. The use of aspirin during the last trimester of pregnancy is particularly cautioned against, as it may lead to adverse effects on fetal development and complications during delivery. Therefore, it is essential that pregnant patients only use aspirin in this period if explicitly directed by a healthcare provider.

Lactation

Lactating mothers are advised to consult a health professional before using this medication. It is particularly important to avoid the use of aspirin during the last three months of pregnancy unless specifically directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery. 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 considering the use of this medication in lactating mothers.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the severity of renal impairment.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to use, particularly if they have conditions such as liver cirrhosis. It is essential for these patients to receive appropriate evaluation and monitoring of their liver function to ensure safe use of the medication. Adjustments to dosage may be necessary based on the severity of hepatic impairment, and ongoing assessment of liver function is recommended throughout the treatment period.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be aware that the symptoms of an overdose may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management of an overdose typically involves supportive care and symptomatic treatment. This may include monitoring vital signs, providing respiratory support if necessary, and administering specific antidotes when indicated. The healthcare provider should follow established protocols and guidelines for the management of overdose cases to ensure optimal patient outcomes.

In summary, timely medical intervention and appropriate management strategies are vital in addressing overdose situations effectively.

Nonclinical Toxicology

It is especially important not to use aspirin during the last three months of pregnancy unless specifically directed by a healthcare professional, as it may lead to complications for the unborn child or during delivery. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Patients should be advised to seek medical help or contact a Poison Control Center immediately in the event of an overdose. It is crucial to inform patients that they should not use this medication if they have ever experienced an allergic reaction to any other pain reliever or fever reducer.

Patients must be instructed to stop using the medication and consult a doctor if they experience any signs of an allergic reaction, and to seek medical assistance right away. Additionally, they should be made aware of the signs of stomach bleeding that warrant immediate medical attention, which include feeling faint, vomiting blood, having bloody or black stools, experiencing stomach pain that does not improve, or noticing ringing in the ears or a loss of hearing. Patients should also be informed to stop use and consult a doctor if pain worsens or lasts for more than 10 days, if fever worsens or lasts more than 3 days, if redness or swelling occurs, or if any new symptoms appear.

Healthcare providers should encourage patients to ask a doctor before using this medication if they have asthma or if the stomach bleeding warning applies to them. It is also important to advise patients to consult a doctor before use if they have a history of stomach problems, such as heartburn, or if they have high blood pressure, heart disease, liver cirrhosis, or kidney disease. Furthermore, patients should be reminded to seek medical advice before using this medication if they are taking a diuretic or a prescription drug for diabetes, gout, or arthritis.

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 within a temperature range of 68-77˚F (20-25˚C) to maintain its efficacy and stability. Proper storage conditions must be adhered to, ensuring that the product is kept in a suitable environment to prevent degradation.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Rapidol Aspirin, 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 Rapidol Aspirin, 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.