Aspirin

Description

H-E-B® Aspirin 325 mg is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the relief of pain and reduction of fever. The product is formulated to provide effective relief for headaches and various aches and pains. Each bottle contains 100 coated tablets, designed for ease of swallowing. The product is tamper evident, with a safety seal under the cap that must remain intact for safe use.

This formulation is comparable to the active ingredient found in Bayer® Genuine Aspirin. The National Drug Code (NDC) for this product is 37808-157-12. H-E-B® Aspirin is manufactured with pride and care in San Antonio, TX 78204, and is backed by a 100% guarantee. It is important to note that this product is not manufactured or distributed by Bayer AG, the owner of the registered trademark Bayer® Genuine Aspirin.

Uses and Indications

This drug is indicated for the temporary relief of minor pain associated with various conditions, including arthritis, headache, muscle pain, menstrual pain, toothache, and pain and fever associated with colds.

There are no teratogenic or nonteratogenic effects reported for this drug.

Dosage and Administration

Patients should adhere strictly to the recommended dosage. Each dose should be taken with a full glass of water to ensure proper administration.

For adults and children aged 12 years and older, the recommended dosage is as follows: 1 or 2 tablets may be taken every 4 hours, or alternatively, 3 tablets may be taken every 6 hours. The total daily dosage must not exceed 12 tablets within a 24-hour period unless specifically directed by a healthcare professional.

For children under 12 years of age, the use of this medication is not recommended unless directed by a physician.

Contraindications

Use of this product is contraindicated in individuals with a known allergy to aspirin or any other pain reliever or fever reducer. Additionally, it should not be used in patients who have a history of allergic reactions to this product or any of its components.

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 this rare but serious illness.

Aspirin may provoke severe allergic reactions, which can manifest as facial swelling, shock, hives, or asthma symptoms such as wheezing. Immediate medical attention should be sought if any of these symptoms 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, those taking anticoagulants or steroid medications, individuals consuming three or more alcoholic beverages daily while using this product, those with a history of stomach ulcers or bleeding disorders, and those who exceed the recommended dosage or duration of use. Additionally, caution is advised for patients taking other medications that contain NSAIDs, including aspirin, ibuprofen, or naproxen.

Healthcare professionals should advise patients to consult a doctor prior to use if they are currently taking diuretics, have a history of stomach issues such as heartburn, or have conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. Patients with asthma should also seek medical advice before using this product. Furthermore, it is recommended that patients consult a doctor or pharmacist if they are taking prescription medications for gout, diabetes, or arthritis.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Patients should discontinue use and contact their healthcare provider if they experience any signs of an allergic reaction, such as difficulty breathing or swelling. Additionally, they should seek medical attention if they notice any symptoms indicative of stomach bleeding, including feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Other concerning symptoms that warrant immediate medical consultation include ringing in the ears or hearing loss, worsening pain lasting more than 10 days, fever persisting beyond three days, visible redness or swelling, or the emergence of new symptoms, as these may signal a serious underlying condition.

Side Effects

Patients using this product should be aware of several serious 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. If patients experience changes in behavior accompanied by nausea and vomiting while using this product, they should consult a doctor immediately, as these symptoms could indicate the onset of Reye's syndrome.

Additionally, there is an allergy alert associated with this product. Aspirin may cause severe allergic reactions, which can manifest as facial swelling, shock, hives, or asthma symptoms such as wheezing. Patients experiencing any signs of an allergic reaction should seek medical help right away.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a warning for the potential risk of severe stomach bleeding. The likelihood of this adverse reaction is increased in patients who are 60 years of age or older, those taking blood-thinning medications or steroids, individuals consuming three or more alcoholic drinks daily while using the product, patients with a history of stomach ulcers or bleeding problems, and those who take the medication for longer than directed or in conjunction with other NSAIDs (including aspirin, ibuprofen, or naproxen).

Patients are advised to stop using the product and consult a doctor if they experience any signs of an allergic reaction or symptoms indicative of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Other concerning symptoms that warrant medical attention include ringing in the ears or loss of hearing, worsening pain lasting more than 10 days, fever that worsens or lasts more than 3 days, redness or swelling, or the emergence of new symptoms. These could be indicative of a serious condition requiring prompt medical evaluation.

Drug Interactions

The concomitant use of anticoagulants or steroid medications is associated with an increased risk of severe gastrointestinal bleeding. Healthcare professionals should exercise caution when prescribing these agents together and consider monitoring for signs of bleeding.

The use of nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin, ibuprofen, and naproxen, may further elevate the risk of gastrointestinal bleeding when taken concurrently with the aforementioned medications. It is advisable to assess the necessity of NSAID therapy in patients receiving anticoagulants or steroids.

Patients on diuretics should consult their healthcare provider prior to initiating treatment, as potential interactions may necessitate dosage adjustments or increased monitoring.

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

Packaging & NDC

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

Pediatric Use

Children and teenagers who have or are recovering from chicken pox 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 essential to consult a doctor, as these may be early signs of Reye's syndrome.

For children under 12 years of age, the use of this product is not recommended unless directed by a doctor. In contrast, adults and children aged 12 years and older may take 1 or 2 tablets every 4 hours or 3 tablets every 6 hours, with a maximum of 12 tablets in a 24-hour period unless otherwise directed by a healthcare professional.

Geriatric Use

Elderly patients, particularly those aged 60 years and older, may have an increased risk of severe stomach bleeding. Healthcare providers should exercise caution when prescribing this medication to geriatric patients, considering the potential for heightened adverse effects.

It is advisable to closely monitor elderly patients for any signs of gastrointestinal bleeding and to evaluate the necessity of dosage adjustments based on individual patient factors. Careful assessment of the benefits and risks is essential in this population to ensure safe and effective use of the medication.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. The use of aspirin during pregnancy, particularly at 20 weeks gestation or later, is associated with potential risks. Specifically, it may lead to adverse effects on fetal development and complications during delivery. Therefore, it is crucial that pregnant patients only use aspirin under the guidance of a qualified healthcare provider, who can assess the benefits and risks in their specific situation.

Lactation

Lactating mothers are advised to consult a healthcare professional before using this medication. It is particularly important to avoid the use of aspirin at 20 weeks of gestation or later 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 during lactation.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have comorbid 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 degree of renal impairment.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to use, particularly if they have underlying 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 vigilant in monitoring for symptoms that may arise from an overdose. While specific symptoms are not detailed in the provided information, it is essential to be aware that they can vary based on the substance involved and the individual patient’s response.

Management of an overdose typically involves supportive care and symptomatic treatment. The healthcare provider should assess the patient's condition and implement appropriate measures based on the severity of the overdose and the symptoms presented. Continuous monitoring and evaluation are recommended to ensure patient safety and effective management of the situation.

Nonclinical Toxicology

It is especially important not to use aspirin at 20 weeks or later in pregnancy unless definitely 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

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is crucial to inform patients that they should not use this product if they have a known allergy to aspirin or any other pain reliever or fever reducer. Additionally, patients must be cautioned against using the product if they have previously experienced an allergic reaction to it or any of its ingredients.

Patients should be instructed to discontinue use and consult a doctor if they experience any signs of an allergic reaction, and to seek medical help immediately in such cases. They should also be made aware of the signs of potential stomach bleeding, which include feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. If any of these symptoms occur, patients should stop using the product and contact their healthcare provider.

Furthermore, patients should be informed to stop use and consult a doctor if they experience ringing in the ears or a loss of hearing, if their pain worsens or persists for more than 10 days, if their fever worsens or lasts more than 3 days, or if they notice any redness or swelling. New symptoms should also prompt a consultation with a healthcare provider, as they may indicate a serious condition.

Patients should be encouraged to consult their doctor before using this product if they are currently taking a diuretic, if they have a history of stomach problems such as heartburn, or if the warning for stomach bleeding applies to them. Additionally, those with high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma should seek medical advice prior to use. Lastly, patients taking prescription medications for gout, diabetes, or arthritis should discuss their use of this product with their doctor or pharmacist.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. It should be stored at a controlled room temperature of 25°C (77°F). Temporary excursions are permitted within the range of 15° to 30°C (59° to 86°F). It is essential to adhere to the expiration date indicated on the package to ensure product efficacy and safety.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is particularly crucial to avoid the use of aspirin after 20 weeks of pregnancy unless specifically directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery.

Drug Information (PDF)

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

View product document (PDF)