Up and up Chewable Aspirin

Description

Chewable aspirin is formulated as a nonsteroidal anti-inflammatory drug (NSAID) with a dosage strength of 81 mg per tablet. Each tablet is designed for oral administration and features an orange flavor to enhance palatability. This product is intended for use in a low-dose aspirin regimen, providing a total of 108 tablets across three bottles, with each bottle containing 36 tablets of 81 mg each.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains.

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

Dosage and Administration

Patients should take a full glass of water with each dose to ensure proper administration.

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

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

Contraindications

Use is contraindicated in patients with a history of allergic reactions to any other pain reliever or fever reducer. Additionally, the product should not be used for at least 7 days following a tonsillectomy or oral surgery, unless specifically directed by a healthcare professional.

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 condition.

Aspirin may provoke severe allergic reactions in some individuals. Symptoms of such reactions can include hives, facial swelling, wheezing, and shock. Healthcare professionals should be vigilant for these signs and advise patients to seek immediate medical attention if they experience any of these symptoms.

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 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.

Patients should be instructed to discontinue use and consult a healthcare provider if they experience any signs of an allergic reaction or symptoms indicative of stomach bleeding. These symptoms include feeling faint, vomiting blood, passing bloody or black stools, experiencing persistent stomach pain, or if pain worsens or lasts longer than 10 days. Additionally, if fever worsens or persists for more than three days, if redness or swelling occurs, if new symptoms arise, or if there is ringing in the ears or loss of hearing, medical advice should be sought promptly.

In the event of an overdose, it is crucial to obtain medical assistance immediately or contact a Poison Control Center at 1-800-222-1222.

Side Effects

Patients using this product should be aware of several serious adverse reactions associated with its use. Notably, Reye’s syndrome is a rare but serious illness that can 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 may indicate the onset of Reye’s syndrome.

Additionally, there is a significant risk of severe allergic reactions to aspirin, which may manifest as hives, facial swelling, asthma (wheezing), 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 risk of severe stomach bleeding. The likelihood of this adverse reaction is increased in patients who are aged 60 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 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 stomach pain that does not improve. Additional symptoms warranting medical attention include worsening pain lasting more than 10 days, fever persisting for more than three days, the presence of redness or swelling, the emergence of new symptoms, or any ringing in the ears or loss of hearing. These symptoms could indicate a serious condition requiring prompt medical evaluation.

Drug Interactions

Patients taking anticoagulants or steroid medications may experience enhanced effects or increased risk of adverse reactions when co-administered with this drug. It is advisable to monitor patients closely for signs of bleeding or other complications, and dosage adjustments may be necessary based on clinical judgment.

Concomitant use of this drug with other nonsteroidal anti-inflammatory drugs (NSAIDs), including prescription and nonprescription options such as aspirin, ibuprofen, and naproxen, may increase the risk of gastrointestinal irritation or bleeding. Clinicians should consider monitoring for gastrointestinal side effects and may need to adjust dosages accordingly to mitigate these risks.

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

Packaging & NDC

Below are the non-prescription pack sizes of Up and up Chewable 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. If any changes in behavior accompanied by nausea and vomiting occur while using this product, it is important to consult a doctor, as these symptoms may indicate the onset of Reye’s syndrome, a rare but serious condition.

For pediatric patients under 12 years of age, consultation with a doctor is advised prior to use.

Geriatric Use

Elderly patients, particularly those aged 60 years and older, are at an increased risk for severe stomach bleeding. This heightened risk necessitates careful consideration when prescribing medications that may exacerbate this condition. Healthcare providers should exercise caution and closely monitor geriatric patients for any signs of gastrointestinal bleeding, especially when initiating or adjusting dosages of relevant therapies.

It is essential for healthcare professionals to evaluate the overall health status and medication regimen of elderly patients to mitigate potential adverse effects associated with stomach bleeding. Regular assessments and patient education regarding the signs and symptoms of gastrointestinal complications are recommended to ensure timely intervention and management.

Pregnancy

Pregnant patients and women 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 outcomes or complications during delivery. Therefore, aspirin should only be used in this period if explicitly directed by a healthcare provider. Caution is advised to ensure the safety of both the mother and the unborn child.

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 gestation or later, 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 conditions such as liver cirrhosis. It is essential for these patients to receive appropriate evaluation and monitoring of their liver function to ensure safe and effective 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. The national Poison Control Center can be reached at 1-800-222-1222.

Healthcare professionals should be aware that timely intervention is crucial in managing overdose situations. Symptoms of overdose may vary depending on the substance involved and the individual’s health status. Therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific symptoms presented. It is recommended that healthcare providers remain vigilant and prepared to implement appropriate interventions based on the clinical presentation of the patient.

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

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 at 1-800-222-1222 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 should be instructed not to use the medication for at least 7 days following a tonsillectomy or oral surgery unless specifically directed by a healthcare professional. They must be made aware that they should stop using the medication and consult a doctor if they experience any signs of an allergic reaction, which may require urgent medical attention.

Healthcare providers should emphasize the importance of stopping use and seeking medical advice if patients notice any signs of stomach bleeding, including feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. Patients should also be informed to seek medical help if pain worsens or lasts longer than 10 days, if fever intensifies or persists for more than 3 days, or if they observe redness or swelling, new symptoms, or experience ringing in the ears or loss of hearing, as these may indicate a serious condition.

Providers should encourage patients to consult with a doctor before using the medication if they have a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies to them. Additionally, patients with high blood pressure, heart disease, liver cirrhosis, or kidney disease should be advised to seek medical guidance prior to use. Those taking diuretics or who have asthma should also be encouraged to discuss their situation with a healthcare professional before using the medication. Lastly, patients should be advised to consult a doctor or pharmacist if they are currently taking prescription medications for gout, diabetes, 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 at a controlled temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy. Proper storage conditions should be ensured to prevent any degradation of the product.

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, consultation with a doctor is recommended prior to use.

Clinicians should counsel patients to discuss any heart-related concerns with their healthcare provider before using this product. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)