Adult Low Dose Aspirin

Description

PHARBEST is a nonsteroidal anti-inflammatory drug (NSAID) containing aspirin as its active ingredient. Each enteric-coated tablet delivers a low dose of 81 mg of aspirin, designed for adult use. The product is available in a bottle containing 120 tablets and is manufactured in the U.S.A. This formulation is comparable to the active ingredient found in BAYER® LOW DOSE. For safety information, please refer to the new warnings provided. The National Drug Code (NDC) for this product is 16103-0356-09.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains, or as recommended by a healthcare professional. Due to its delayed action, this product may not provide immediate relief for headaches or other symptoms requiring prompt alleviation.

Healthcare professionals are encouraged to inquire about additional uses for this product based on individual patient needs.

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

Dosage and Administration

Patients are advised to take a full glass of water with each dose to ensure proper administration and absorption of the medication.

For adults and children aged 12 years and older, the recommended dosage is 4 to 8 tablets every 4 hours as needed while symptoms persist. It is imperative not to exceed a total of 48 tablets within a 24-hour period unless otherwise directed by a physician.

For children under 12 years of age, it is essential to consult a physician for appropriate dosing recommendations.

Contraindications

Use is contraindicated in individuals with a history of allergic reactions to aspirin or any other pain reliever or fever reducer. Due to the potential for severe allergic responses, such patients should avoid this product.

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 hives, asthma (wheezing), facial swelling, or shock. 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.

Before initiating treatment, patients should consult a healthcare provider if any of the following conditions apply: a history of stomach problems such as heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Additionally, it is advisable to seek guidance from a doctor or pharmacist if the patient is currently taking prescription medications for gout, diabetes, or arthritis.

In the event of an accidental 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 a healthcare professional if they experience any signs of stomach bleeding, including feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Other reasons to stop use include the occurrence of an allergic reaction, worsening pain lasting more than 10 days, presence of redness or swelling, emergence of new symptoms, or symptoms such as ringing in the ears or loss of hearing. These may indicate a serious condition requiring medical evaluation.

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 hives, asthma (wheezing), facial swelling, or shock. Patients should seek immediate medical attention if they experience any signs of an allergic reaction.

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, have a history of stomach ulcers or bleeding problems, are taking blood-thinning medications or steroids, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic drinks daily while using this product, 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 feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Other reasons to discontinue use and seek medical advice include the occurrence of an allergic reaction, worsening pain that lasts more than 10 days, the presence of redness or swelling, the emergence of any new symptoms, or symptoms such as ringing in the ears or loss of hearing, as these could indicate a serious condition.

Drug Interactions

Taking this product concurrently with other medications that contain nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin, ibuprofen, or naproxen, may elevate the risk of gastrointestinal bleeding. This risk is further exacerbated in patients who are also using anticoagulants or steroid medications, which can lead to a higher incidence of severe stomach bleeding.

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

Packaging & NDC

Below are the non-prescription pack sizes of Adult Low Dose 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 changes in behavior accompanied by nausea and vomiting occur while using this product, it is important to consult a physician, as these may be early signs of Reye's syndrome.

For dosing, adults and children aged 12 years and older are directed to take 4 to 8 tablets every 4 hours while symptoms persist, with a maximum of 48 tablets in 24 hours unless otherwise directed by a physician. For children under 12 years of age, consultation with a physician is recommended prior to use.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk of severe stomach bleeding. It is essential for healthcare providers to exercise caution when prescribing medications that may exacerbate this risk in this population.

Close monitoring of gastrointestinal symptoms is recommended for geriatric patients, especially when initiating or adjusting dosages of medications known to affect gastric mucosa. Healthcare providers should consider the overall health status and concurrent medications of elderly patients to mitigate potential adverse effects.

Dose adjustments may be necessary based on individual patient assessments, taking into account the heightened susceptibility to complications such as stomach bleeding in this age group.

Pregnancy

Pregnant patients should consult a healthcare professional before using this medication, particularly if they are in the later stages of pregnancy or breastfeeding. The use of aspirin during the last trimester is particularly cautioned against, as it may pose risks to the unborn child and lead to complications during delivery. Therefore, it is essential that pregnant patients only use aspirin under the guidance of a qualified healthcare provider, especially in the final three months of pregnancy.

Lactation

Lactating mothers are advised to consult a healthcare 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 while breastfeeding.

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 accidental 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 overdosage.

Healthcare professionals should be aware that the symptoms of overdose may vary depending on the specific 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. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where specific antidotes are available, their administration should be considered based on the clinical scenario.

It is essential for healthcare providers to remain vigilant and prepared to implement emergency protocols in the event of an overdose, ensuring the best possible outcomes for affected individuals.

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 regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an accidental overdose.

Patients should be instructed to 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. Additionally, they should seek medical advice if they notice any allergic reactions, if their pain worsens or lasts longer than 10 days, if redness or swelling occurs, if any new symptoms arise, or if they experience ringing in the ears or loss of hearing, as these could indicate a serious condition.

It is important for patients to consult with their healthcare provider before using the medication if the stomach bleeding warning is applicable to them, or if they have a history of stomach issues such as heartburn. Patients with high blood pressure, heart disease, liver cirrhosis, or kidney disease should also seek guidance prior to use. Those with asthma or who are taking a diuretic should be encouraged to discuss their situation with their healthcare provider.

Furthermore, patients should be advised to consult a doctor or pharmacist before using the medication if they are currently taking prescription drugs for gout, diabetes, or arthritis. This ensures that any potential interactions or contraindications are appropriately managed.

Storage and Handling

The product is supplied in a tamper-evident container. It should not be used if the safety seal under the cap is broken or missing.

For optimal storage, the product must be kept at room temperature, specifically between 15° and 30°C. It is essential to avoid exposure to excess heat and moisture to maintain the integrity of the product.

Additional Clinical Information

The route of administration for the medication is oral. Clinicians should advise 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.

Drug Information (PDF)

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

View product document (PDF)