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Aspirin 5 Grain

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This product has been discontinued

Active ingredient
Aspirin 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 2015
Label revision date
October 1, 2019
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Aspirin 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 2015
Label revision date
October 1, 2019
Manufacturer
Provision Medical Products
Registration number
part343
NDC root
69103-2501
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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Drug Overview

Aspirin is a medication commonly used to temporarily relieve pain from headaches, minor arthritis, and muscular aches. It is also effective in reducing fever and can help alleviate discomfort associated with the common cold. By targeting the underlying causes of pain and fever, aspirin provides a supportive option for managing these common health issues.

Uses

You can use this medication to temporarily relieve various types of pain, including headaches, minor arthritis pain, and muscular aches. It also helps to reduce fever and can provide relief from symptoms associated with the common cold.

This medication is designed to help you feel more comfortable when dealing with these common ailments, allowing you to go about your day with less discomfort.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you can take 2 tablets every 4 to 6 hours as needed for relief. However, it's important not to exceed 12 tablets in a 24-hour period unless your doctor advises otherwise.

For children under 12 years of age, it's essential to consult a doctor before giving them this medication. Always follow the recommended dosage and do not use more than directed to ensure your safety and well-being.

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 particular situations or conditions under which you should avoid using it. Always consult with your healthcare provider for personalized advice and to ensure that this medication is appropriate for your individual health needs.

Side Effects

You should be aware of some important side effects and warnings associated with this medication. Children and teenagers should not use it for chickenpox or flu symptoms without consulting a doctor first, as it can lead to Reye's syndrome, a rare but serious condition. Additionally, if you drink three or more alcoholic beverages daily, it's best to check with your doctor before taking aspirin, as it may cause stomach bleeding.

You should avoid using this medication if you are allergic to aspirin or any other pain reliever/fever reducer, or if you have had an allergic reaction to these medications in the past. It's also important to consult a doctor if you have asthma, gastric ulcers, bleeding problems, or stomach issues like heartburn. If you experience ringing in the ears, loss of hearing, or if your pain or fever worsens or persists, stop using the medication and seek medical advice.

Warnings and Precautions

You should be aware of some important warnings and precautions when using this medicine. Children and teenagers should not use it for chicken pox or flu symptoms without first consulting a doctor due to the risk of Reye's syndrome, a rare but serious illness linked to aspirin. If you drink three or more alcoholic beverages daily, talk to your doctor before taking aspirin or other pain relievers, as aspirin can also cause stomach bleeding. Avoid using this medicine if you are allergic to aspirin, have had allergic reactions to other pain relievers, or if you are taking any other products containing aspirin. Additionally, do not use it for pain longer than 10 days or for fever longer than 3 days unless directed by a doctor.

Before using this medicine, consult your doctor if you have asthma, gastric ulcers, bleeding problems, or stomach issues like heartburn or pain. It's also wise to check with your doctor or pharmacist if you are on prescription medications for blood thinning, diabetes, gout, or arthritis. If you experience ringing in your ears, loss of hearing, worsening pain or fever, new symptoms, or any redness or swelling, stop using the medicine and contact your doctor. In case of an overdose, seek emergency medical help or contact a Poison Control Center immediately, as prompt attention is crucial for both adults and children.

Overdose

It's important to always follow the recommended dose when using this product. Taking more than the suggested amount can lead to an overdose, which may cause serious health issues.

If you suspect an overdose, look for signs such as unusual drowsiness, confusion, or difficulty breathing (respiratory depression). If you notice any of these symptoms, seek immediate medical help or contact your local poison control center. Remember, it's always better to be safe and get professional assistance if you're unsure.

Pregnancy Use

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

Particularly, you should avoid using aspirin during the last three months of your pregnancy unless your doctor specifically instructs you to do so. Taking aspirin at this stage can lead to potential problems 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 ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

It's important to be cautious when considering this medicine for your child. If your child has chicken pox or flu symptoms, you should consult a doctor first, as there is a risk of Reye's syndrome, a rare but serious illness linked to aspirin use in these cases.

For children and teenagers, the recommended dosage varies. Adults and children aged 12 and older can take 2 tablets every 4 to 6 hours as needed, but they should not exceed 12 tablets in a 24-hour period unless directed by a doctor. If your child is under 12 years old, it's essential to consult a doctor before giving them this medicine.

Geriatric Use

While there is no specific information about the use of this medication in older adults, it’s important to remember that each person’s health needs can vary. Since the insert does not mention any recommended age considerations, dosage adjustments, or safety concerns for elderly patients, you should always consult with a healthcare provider before starting any new medication. They can help ensure that the treatment is appropriate for your individual health situation and any other medications you may be taking.

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 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 apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

Drug Interactions

It's important to talk to your doctor or pharmacist before using this medication, especially if you are currently taking prescription drugs for conditions like blood thinning (anticoagulation), diabetes, gout, or arthritis. These medications can interact in ways that may affect your health.

Additionally, you should avoid using this medication alongside other pain relievers or fever reducers, as well as any products that contain aspirin. Discussing all your medications and any over-the-counter products with your healthcare provider can help 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 protect it from light and keep the container tightly closed when not in use. Always keep the product out of reach of children to prevent accidental ingestion or misuse. Once opened, please remember to discard the product to maintain safety and quality.

Additional Information

You should take this medication orally. If you are pregnant or breastfeeding, it's important to consult a healthcare professional before using it. Avoid using aspirin during the last three months of pregnancy unless your doctor specifically advises it, as it can cause issues for the unborn child or complications during delivery.

Keep this medication out of reach of children. In case of an overdose, seek medical help or contact a Poison Control Center immediately, as prompt attention is crucial for both adults and children, even if no symptoms are present. Additionally, children and teenagers should not use this medicine for chickenpox or flu symptoms without consulting a doctor first due to the risk of Reye's syndrome, a rare but serious condition linked to aspirin. If you drink three or more alcoholic beverages daily, talk to your doctor about whether you should take aspirin or other pain relievers.

FAQ

What is Aspirin used for?

Aspirin is used to temporarily relieve pain from headaches, minor arthritis pain, muscular aches, and to reduce fever and symptoms of the common cold.

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

Adults and children 12 years of age and older should take 2 tablets every 4 to 6 hours as needed, without exceeding 12 tablets in 24 hours, unless directed by a doctor.

Are there any warnings associated with Aspirin?

Yes, Aspirin may cause stomach bleeding and should not be used by children and teenagers for chicken pox or flu symptoms without consulting a doctor due to the risk of Reye's syndrome.

What should I do if I experience ringing in the ears or loss of hearing?

You should stop using Aspirin and consult a doctor if you experience ringing in the ears or loss of hearing.

Can I take Aspirin if I am pregnant or breastfeeding?

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

What should I do in case of an overdose?

In case of overdose, seek medical help or contact a Poison Control Center immediately, as prompt medical attention is critical.

Who should consult a doctor before using Aspirin?

You should consult a doctor if you have asthma, gastric ulcers, bleeding problems, or if you are taking prescription drugs for anticoagulation, diabetes, gout, or arthritis.

How should Aspirin be stored?

Store Aspirin at room temperature, between 20°C to 25°C (68°F to 77°F), protect it from light, and keep it out of reach of children.

Packaging Info

Below are the non-prescription pack sizes of Aspirin 5 Grain (aspirin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Aspirin 5 Grain.
Details

Drug Information (PDF)

This file contains official product information for Aspirin 5 Grain, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

The product is a box containing 5 grain aspirin. Aspirin, also known as acetylsalicylic acid, is a nonsteroidal anti-inflammatory drug (NSAID) used for its analgesic, antipyretic, and anti-inflammatory properties. The formulation is designed for oral administration. Each grain is equivalent to approximately 64.8 milligrams of aspirin. The packaging is intended to ensure the stability and integrity of the active ingredient.

Uses and Indications

This drug is indicated for the temporary relief of pain associated with headache, minor pain of arthritis, and muscular aches. Additionally, it is indicated for the temporary reduction of fever and the alleviation of discomfort associated with the common cold.

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 2 tablets every 4 to 6 hours as needed. The total daily dosage must not exceed 12 tablets within a 24-hour period, unless otherwise directed by a healthcare professional.

For children under 12 years of age, it is essential to consult a doctor prior to administration. It is imperative that the medication is not used in excess of the recommended dosage.

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 be informed of the following warnings and precautions associated with the use of this medication.

Reye's Syndrome Children and teenagers must not use this medication for chickenpox or flu symptoms without prior consultation with a healthcare provider regarding the risk of Reye's syndrome, a rare but serious condition linked to aspirin use.

Alcohol Consumption Patients who consume three or more alcoholic beverages daily should consult their healthcare provider before taking aspirin or any other pain relievers or fever reducers.

Gastrointestinal Risks Aspirin is associated with an increased risk of stomach bleeding. Therefore, it is crucial to avoid the use of this medication in the following circumstances:

  • In individuals with a known allergy to aspirin.

  • In conjunction with any other pain reliever or fever reducer.

  • In patients with a history of allergic reactions to other pain relievers or fever reducers.

  • For pain lasting more than 10 days or for fever persisting beyond 3 days unless directed by a healthcare professional.

  • In combination with any other product containing aspirin.

Pre-existing Conditions Patients should seek medical advice before using this medication if they have:

  • Asthma.

  • Gastric ulcers.

  • Bleeding disorders.

  • Stomach issues, including heartburn, upset stomach, or stomach pain.

Drug Interactions Consultation with a healthcare provider or pharmacist is recommended prior to use if the patient is currently taking prescription medications for:

  • Anticoagulation (blood thinning).

  • Diabetes.

  • Gout.

  • Arthritis.

Monitoring and Discontinuation Patients are advised to discontinue use and consult a healthcare provider if they experience:

  • Ringing in the ears or loss of hearing.

  • Persistent or worsening pain or fever.

  • The emergence of new symptoms.

  • Redness or swelling at the site of use.

Emergency Situations In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are immediately apparent.

Side Effects

Patients using this medication may experience a range of adverse reactions, which can be categorized by seriousness and frequency.

Serious adverse reactions include Reye's syndrome, a rare but serious illness associated with aspirin use in children and teenagers for chicken pox or flu symptoms. It is crucial that these patients consult a doctor prior to using this medication. Additionally, aspirin may cause stomach bleeding, which is a significant concern for patients with a history of gastric ulcers, bleeding problems, or other stomach issues such as heartburn or upset stomach.

Common adverse reactions may include gastrointestinal disturbances, and patients are advised to stop use and consult a doctor if they experience ringing in the ears or loss of hearing. Other indications to discontinue use include persistent or worsening pain or fever, the emergence of new symptoms, or the presence of redness or swelling.

Patients should be cautious and seek medical advice before using this medication if they have asthma, gastric ulcers, bleeding problems, or stomach issues. Furthermore, individuals taking prescription medications for anticoagulation, diabetes, gout, or arthritis should also consult a healthcare professional prior to use.

This medication should not be used in patients who are allergic to aspirin or any other pain reliever/fever reducer, nor should it be combined with other products containing aspirin. It is also contraindicated for pain lasting more than 10 days or fever persisting for more than 3 days unless directed by a doctor. Additionally, patients who consume three or more alcoholic drinks daily should seek medical advice regarding the use of aspirin or other pain relievers/fever reducers.

Drug Interactions

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking prescription drugs for anticoagulation, diabetes, gout, or arthritis. The potential for interactions with these classes of medications necessitates careful consideration and monitoring.

In addition, this medication should not be used in conjunction with any other pain reliever or fever reducer. The risk of additive effects may lead to increased adverse reactions or toxicity.

Furthermore, it is contraindicated to use this medication alongside any other products containing aspirin. The combination may elevate the risk of gastrointestinal bleeding and other serious side effects.

Healthcare providers should assess the need for dosage adjustments or enhanced monitoring for patients who are on these concurrent therapies to ensure safety and efficacy.

Packaging & NDC

Below are the non-prescription pack sizes of Aspirin 5 Grain (aspirin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Aspirin 5 Grain.
Details

Pediatric Use

Pediatric patients, including children and teenagers, should not use this medicine for chicken pox or flu symptoms without prior consultation with a healthcare professional due to the risk of Reye's syndrome, a rare but serious illness associated with aspirin use.

For dosing, adults and children aged 12 years and older may take 2 tablets every 4 to 6 hours as needed, with a maximum of 12 tablets in a 24-hour period, or as directed by a physician. Children under 12 years of age are advised to consult a doctor before use.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients. The prescribing information does not provide any recommended age considerations, dosage adjustments, safety concerns, or special precautions for elderly patients.

Healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, considering the absence of data specific to this population. Monitoring for efficacy and safety is advised, as individual responses may vary.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to use. 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 and lead to complications during delivery. Healthcare providers should carefully consider the potential fetal impacts and weigh the benefits against the risks when advising pregnant patients.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 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

Exceeding the recommended dose of this product may lead to overdosage, which can result in serious health consequences. Healthcare professionals are advised to monitor patients closely for any signs of overdosage and to take appropriate action if necessary.

In the event of suspected overdosage, it is crucial to assess the patient for potential symptoms, which may vary depending on the specific circumstances and individual patient factors. Immediate medical attention should be sought, and supportive care should be initiated as needed.

Management of overdosage should include the following steps:

  1. Assessment: Evaluate the patient's clinical status, including vital signs and level of consciousness.

  2. Supportive Care: Provide symptomatic treatment as required, which may include intravenous fluids, monitoring of electrolytes, and other supportive measures.

  3. Consultation: Engage with a poison control center or toxicology specialist for guidance on specific interventions and antidotes, if applicable.

It is imperative that healthcare professionals adhere to the recommended dosing guidelines to minimize the risk of overdosage and ensure patient safety.

Nonclinical Toxicology

It is especially important not to use aspirin during the last three months of pregnancy unless specifically directed to do so by a doctor, as it may cause problems in the unborn child or complications 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

Postmarketing experience has identified Reye's syndrome as a serious illness that may be associated with the use of this medicine in children and teenagers for chicken pox or flu symptoms. It is recommended that consultation with a healthcare professional occurs prior to use in this population. Additionally, reports have indicated that aspirin may cause stomach bleeding.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is important to emphasize the necessity of seeking immediate medical assistance or contacting a Poison Control Center in the event of an overdose. Patients should be informed that prompt medical attention is critical for both adults and children, even if they do not exhibit any signs or symptoms of overdose. This proactive approach can help ensure safety and effective management in case of an emergency.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain 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 ensure its efficacy. Additionally, the product should be kept out of reach of children, and any unused portion should be discarded after opening to prevent potential safety risks.

Additional Clinical Information

Patients should be informed that the medication is administered orally. Clinicians are advised to counsel patients who are pregnant or breastfeeding to consult a health professional prior to use. It is particularly crucial to avoid 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.

Additionally, patients should be cautioned to keep the medication out of reach of children. In the event of an overdose, immediate medical assistance or contact with a Poison Control Center is essential, as prompt attention is critical for both adults and children, even in the absence of symptoms. Children and teenagers should not use this medication for chickenpox or flu symptoms without prior consultation regarding the risk of Reye's syndrome, a rare but serious condition associated with aspirin. An alcohol warning is also pertinent; individuals consuming three or more alcoholic drinks daily should consult their doctor regarding the use of aspirin or other pain relievers/fever reducers.

Drug Information (PDF)

This file contains official product information for Aspirin 5 Grain, 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 Aspirin 5 Grain, 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.