Pain Relief Aspirin

Description

NDC 11822-0397-7 identifies this product as a chewable low dose pain relief aspirin, containing 81 mg of the active ingredient. The formulation is presented in the form of chewable tablets, which are designed to be chewed or crushed completely before swallowing. The tablets are cherry-flavored and packaged in a container that holds 36 chewable tablets. This product functions as a nonsteroidal anti-inflammatory drug (NSAID) for pain relief.

It is important to note that this product is not manufactured or distributed by Bayer AG, the owner of the registered trademark Bayer® Chewable Low Dose Aspirin. The product is distributed by Rite Aid, located at 200 Newberry Commons, Etters, PA 17319. The packaging includes a tamper-evident feature, and users are advised not to use the product if the imprinted safety seal under the cap is broken or missing.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains, or as recommended by a healthcare professional.

Limitations of Use: There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Patients should adhere strictly to the recommended dosage and administration guidelines. It is imperative not to exceed the directed dosage.

For adults and children aged 12 years and older, the recommended dosage is 4 to 8 chewable tablets every 4 hours. The total daily intake must not exceed 48 chewable tablets within a 24-hour period unless otherwise directed by a healthcare professional.

Patients are advised to drink a full glass of water with each dose to facilitate proper swallowing and absorption. It is essential that the tablets are chewed or crushed completely before swallowing; swallowing the tablets whole is not recommended.

For children under 12 years of age, the use of this medication is not advised unless specifically directed by a healthcare provider.

Contraindications

Use of this product is contraindicated in the following situations:

Patients with a known allergy to aspirin or any other pain reliever or fever reducer should not use this product due to the risk of severe allergic reactions.

Additionally, the product should not be administered for at least 7 days following a tonsillectomy or oral surgery unless specifically directed by a healthcare professional, as it may interfere with the healing process.

Lastly, individuals who have previously experienced an allergic reaction to this product or any of its ingredients should avoid its use to prevent potential adverse effects.

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 in some individuals. Symptoms of such reactions can include hives, facial swelling, shock, and asthma (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 patients who are taking anticoagulants or steroid medications, are aged 60 years or older, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic beverages daily while using this product, have a history of stomach ulcers or bleeding problems, or exceed the recommended dosage or duration of use.

Healthcare professionals should advise patients to consult a doctor prior to using this product if any of the following conditions apply: a history of stomach problems (such as heartburn), high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or if they are taking diuretics. Additionally, patients should seek guidance from a doctor or pharmacist if they are currently prescribed 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 are advised to discontinue use and contact their healthcare provider if they experience any signs of an allergic reaction, such as hives or swelling. They should also seek medical attention if they notice any symptoms indicative of stomach bleeding, including vomiting blood, passing bloody or black stools, feeling faint, 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 that worsens or persists 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, this product may cause severe allergic reactions in some individuals. Symptoms of such reactions can include hives, facial swelling, shock, and asthma (wheezing). Patients experiencing any signs of an allergic reaction should seek medical help right away.

The product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of this adverse reaction is increased in patients who are taking blood thinners or steroid medications, are aged 60 or older, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic drinks daily while using the product, have a history of stomach ulcers or bleeding problems, or exceed the recommended dosage or duration of use.

Patients are advised to stop using the product and consult a doctor if they experience any signs of stomach bleeding, which may include vomiting blood, having bloody or black stools, feeling faint, or experiencing persistent stomach pain. Other 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 three days, redness or swelling, or the emergence of new symptoms. These could be indicative of a serious condition requiring prompt evaluation.

Drug Interactions

The use of this product, which contains a nonsteroidal anti-inflammatory drug (NSAID), is associated with an increased risk of severe stomach bleeding. This risk is particularly heightened under certain conditions, including concomitant use of anticoagulants or steroid medications, advanced age (60 years or older), concurrent administration of other NSAIDs (whether prescription or over-the-counter, such as aspirin, ibuprofen, or naproxen), excessive alcohol consumption (three or more alcoholic drinks daily), a history of stomach ulcers or bleeding disorders, and prolonged use or higher dosages than recommended.

Patients are advised to consult a healthcare professional prior to using this product if they are currently taking prescription medications for gout, diabetes, or arthritis. Monitoring for signs of gastrointestinal bleeding is recommended, especially in patients with the aforementioned risk factors. Adjustments to dosage or alternative therapies may be necessary based on individual patient circumstances and concurrent medication use.

Packaging & NDC

Below are the non-prescription pack sizes of Pain Relief Aspirin (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 pediatric patients experience changes in behavior accompanied by nausea and vomiting while using this product, a healthcare professional should be consulted, as these symptoms may indicate the onset of Reye's syndrome.

For children under 12 years of age, the product should not be used unless directed by a doctor. In contrast, for adults and children aged 12 years and older, the recommended dosage is 4 to 8 chewable tablets every 4 hours, with a maximum of 48 chewable tablets in a 24-hour period unless otherwise directed by a healthcare professional.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk for severe stomach bleeding. This heightened risk necessitates careful consideration when prescribing medications that may contribute to gastrointestinal bleeding. Healthcare providers should closely monitor geriatric patients for any signs of gastrointestinal distress and consider appropriate dose adjustments or alternative therapies to mitigate this risk. It is essential to evaluate the overall health status and concurrent medications of elderly patients to ensure safe and effective treatment outcomes.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to use. The use of aspirin during pregnancy, particularly at 20 weeks gestation or later, is associated with potential risks. Specifically, aspirin may lead to adverse effects on fetal outcomes or complications during delivery. Therefore, it is crucial that pregnant patients only use aspirin under the guidance of a qualified healthcare provider if deemed necessary.

Lactation

Lactating mothers are advised to consult a health professional before using this medication. It is particularly important to avoid the use of aspirin at 20 weeks of pregnancy 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 high blood pressure, heart disease, liver cirrhosis, or kidney disease. Additionally, it is advisable for patients to seek guidance from a doctor or pharmacist if they are currently taking a prescription medication for kidney disease.

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 to assess liver function and consider potential dosage adjustments or monitoring requirements based on the severity of hepatic impairment. Close monitoring of liver function tests may be warranted to ensure safety and efficacy in this patient population.

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 assess the patient for any signs of toxicity or distress.

Management of an overdose should be guided by the severity of symptoms and the clinical judgment of the healthcare provider. Supportive care and symptomatic treatment may be necessary, and the involvement of poison control experts can provide additional guidance on the appropriate management strategies.

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 or additional nonclinical toxicology details are available in the provided data. Furthermore, there are no specific findings related to animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as hives, facial swelling, shock, and asthma (wheezing). Additionally, stomach bleeding has been noted, particularly in patients who are older, take blood thinners or steroids, consume alcohol regularly, or have a history of stomach ulcers or bleeding problems.

Serious conditions associated with the use of this product include reports of vomiting blood, bloody or black stools, fainting, persistent stomach pain, ringing in the ears or loss of hearing, worsening pain or fever lasting beyond specified durations, presence of redness or swelling, and the occurrence of new symptoms.

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 should be cautioned against using the product for at least 7 days following a tonsillectomy or oral surgery unless specifically directed by a healthcare professional.

Patients must be made aware that they should discontinue use and consult a doctor if they experience any signs of an allergic reaction, which may necessitate urgent medical attention. They should also be instructed to stop using the product and seek medical advice if they notice any symptoms indicative of stomach bleeding, such as vomiting blood, having bloody or black stools, feeling faint, or experiencing persistent stomach pain.

Furthermore, patients should be informed to stop use and consult a doctor if they experience ringing in the ears, a loss of hearing, worsening pain that lasts more than 10 days, or a fever that persists beyond 3 days. Any signs of redness or swelling, as well as the emergence of new symptoms, should prompt patients to seek medical advice, as these may indicate a serious condition.

Healthcare providers should encourage patients to consult a doctor before using the product if they have a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies to them. It is also important to advise patients to seek medical guidance if they have high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Additionally, patients taking diuretics or prescription medications for gout, diabetes, or arthritis should be encouraged to discuss their current medications with a doctor or pharmacist prior to use.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for reference. It should be stored at a controlled room temperature of 25ºC (77ºF), with permissible excursions between 15ºC and 30ºC (59ºF to 86ºF).

Healthcare professionals are advised to check the end flap of the packaging for the expiration date and lot number to ensure proper inventory management and product safety.

Additional Clinical Information

The medication is administered orally, with specific dosing guidelines for different age groups. Adults and children aged 12 years and older are advised to take 4 to 8 chewable tablets every 4 hours, not exceeding 48 tablets in a 24-hour period unless directed by a physician. For children under 12 years, use is not recommended unless directed by a healthcare provider.

Clinicians should counsel patients to consult with their doctor or healthcare provider prior to using this product, particularly for heart-related issues. Pregnant or breastfeeding patients should seek professional advice before use, as the medication, especially aspirin, may pose risks during pregnancy, particularly after 20 weeks, unless specifically directed by a physician.

Drug Information (PDF)

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

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