Solves - Aspirin

Description

NDC 62309-779. ZIPPER is a dissolvable oral strip formulation containing 81 mg of aspirin, classified as a nonsteroidal anti-inflammatory drug (NSAID) and indicated for pain relief. Each package contains five strips, which are artificially flavored with a wild cherry flavor. The product is designed for quick dissolution and ease of administration.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains, or as recommended by a healthcare professional. Healthcare providers may consider additional uses for Solves Strips 81 mg aspirin based on individual patient needs.

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

Dosage and Administration

This medication is to be taken by mouth. Each dose should be administered with a full glass of water, unless otherwise directed by a healthcare professional.

For adults and children aged 12 years and older, the recommended dosage is 4 to 6 strips every 4 hours. The total daily dosage must not exceed 36 strips within a 24-hour period, unless specifically instructed by a physician.

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

Contraindications

Use is contraindicated in individuals with a known allergy to aspirin or any other pain reliever or fever reducer. Due to the potential for severe allergic reactions, administration in these patients is not recommended.

Warnings and Precautions

Children and teenagers who have or are recovering from chickenpox or flu-like symptoms should not use this product. The use of this product in these populations poses a risk of serious complications.

When administering this product, healthcare professionals should be vigilant for any changes in behavior accompanied by nausea and vomiting, as these may indicate the onset of Reye's Syndrome, a rare but potentially life-threatening condition. Immediate consultation with a physician is advised if such symptoms arise.

Aspirin, a component of this product, may elicit severe allergic reactions, which can manifest as hives, facial swelling, asthma (wheezing), or even shock. Healthcare providers should be aware of these potential reactions and monitor patients accordingly.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe gastrointestinal bleeding. The likelihood of such an event is increased in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding disorders, are concurrently using anticoagulants or steroid medications, are taking other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic beverages daily while using this product, or exceed the recommended dosage or duration of use.

Healthcare professionals should advise patients to consult a physician prior to use if any of the following conditions apply: a history of stomach bleeding, heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, current use of diuretics, asthma, or recent tonsillectomy or oral surgery within the past seven days. Additionally, patients should be encouraged to seek guidance from a doctor or pharmacist if they are taking prescription medications for gout, diabetes, arthritis, or anticoagulation therapy.

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

Patients should be instructed to discontinue use and contact their healthcare provider if they experience any signs of an allergic reaction, symptoms indicative of stomach bleeding (such as feeling faint, vomiting blood, passing bloody or black stools, or persistent stomach pain), worsening pain lasting more than ten days, fever persisting beyond three days, the presence of redness or swelling, the emergence of new symptoms, or any ringing in the ears or loss of hearing.

Side Effects

Patients using this product should be aware of several serious and common adverse reactions associated with its use.

Reye's syndrome is a significant concern, particularly for children and teenagers who have or are recovering from chickenpox or flu-like symptoms. These individuals should not use this product. If patients experience changes in behavior accompanied by nausea and vomiting, they should consult a doctor immediately, as these symptoms may indicate the onset of Reye's syndrome, a rare but serious illness.

Aspirin, a component of this product, may provoke severe allergic reactions in some patients. Symptoms of such reactions can include hives, facial swelling, asthma (wheezing), and shock. Patients experiencing any signs of an allergic reaction should seek medical assistance without delay.

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 60 years of age or older, have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid medications, 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 should be 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. Additionally, patients should seek medical advice if pain worsens or lasts more than 10 days, if fever persists for more than three days, if redness or swelling occurs, if new symptoms arise, or if they experience ringing in the ears or loss of hearing.

Drug Interactions

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking prescription drugs for gout, diabetes, arthritis, or anticoagulation.

This precaution is essential to ensure safe and effective use, as potential interactions may alter the therapeutic effects or increase the risk of adverse reactions. Monitoring and dosage adjustments may be necessary based on the specific medications involved and the patient's overall health status.

Packaging & NDC

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

Pediatric Use

Pediatric patients, particularly children and teenagers, should not use this product if they have or are recovering from chicken pox or flu-like symptoms due to the risk of Reye's syndrome. If any changes in behavior accompanied by nausea and vomiting occur, it is important to consult a healthcare professional, as these may be early signs of Reye's syndrome.

For dosing, adults and children aged 12 years and older may take 4 to 6 strips every 4 hours, with a maximum of 36 strips in a 24-hour period unless otherwise directed by a doctor. For children under 12 years of age, it is essential to consult a doctor before use.

Geriatric Use

Elderly patients, particularly those aged 60 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 these patients for any signs of gastrointestinal bleeding and to evaluate the necessity of dosage adjustments based on individual patient factors. Careful assessment of the risk-benefit ratio is essential in this population to ensure safe and effective treatment.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to use. The use of aspirin during the last trimester of pregnancy is particularly cautioned against, as it may lead to adverse effects on fetal outcomes or complications during delivery. Therefore, it is essential that pregnant patients only use aspirin in this period if explicitly directed by a healthcare provider.

Lactation

Lactating mothers are advised to consult a health 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 its use in lactating mothers.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have a history of kidney disease. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the degree of impairment.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to use, particularly if they have a history of liver cirrhosis. It is essential for these patients to disclose any existing conditions, including stomach problems such as heartburn, high blood pressure, heart disease, or kidney disease, as these factors may influence the safety and efficacy of the treatment. Monitoring of liver function may be warranted in patients with compromised liver function to ensure appropriate management and to mitigate potential risks associated with the use of this medication.

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 for symptoms that may arise from an overdose, although specific symptoms are not detailed in the provided information. The management of an overdose typically involves supportive care and symptomatic treatment, tailored to the individual patient's needs.

It is essential for healthcare providers to remain alert and prepared to implement appropriate management strategies in response to an overdose situation.

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 provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Serious side effects have been reported voluntarily or through surveillance programs. Individuals are encouraged to report any serious adverse events to the designated phone number for further evaluation and monitoring.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help or contact a Poison Control Center immediately.

Patients must be informed not to use this product if they have a known allergy to aspirin or any other pain reliever or fever reducer. They should be encouraged to stop using the medication and consult a doctor if they experience any signs of an allergic reaction, such as difficulty breathing or swelling of the face or throat. Additionally, patients should seek medical attention if they notice symptoms indicative of stomach bleeding, including feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. They should also be advised to contact a healthcare professional if their pain worsens or lasts longer than 10 days, if a fever persists for more than 3 days, if redness or swelling occurs, if new symptoms develop, or if they experience ringing in the ears or loss of hearing.

When using this product, patients should be made aware that changes in behavior accompanied by nausea and vomiting may signal the onset of Reye's Syndrome, a rare but serious condition, and they should consult a doctor if these symptoms arise.

Healthcare providers should recommend that patients ask a doctor before use if they have a history of stomach problems, such as heartburn, or if they have high blood pressure, heart disease, liver cirrhosis, or kidney disease. Patients taking diuretics, those with asthma, or individuals who have undergone a tonsillectomy or oral surgery within the last 7 days should also consult a doctor prior to use. Furthermore, patients should be advised to speak with a doctor or pharmacist before using this medication if they are currently taking prescription drugs for gout, diabetes, arthritis, or anticoagulation.

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 room temperature to maintain its integrity and efficacy. Proper handling should be observed to ensure optimal conditions are met throughout the storage period.

Additional Clinical Information

Patients should take this medication by mouth, accompanied by a full glass of water unless otherwise directed by a healthcare provider. For adults and children aged 12 years and older, the recommended dosage is 4 to 6 strips every 4 hours, not exceeding 36 strips within a 24-hour period unless advised by a physician. For children under 12 years of age, consultation with a doctor is necessary before administration.

Clinicians should counsel patients regarding the use of this medication during pregnancy or breastfeeding, advising them to consult a health professional prior to use. It is particularly important to avoid aspirin during the last trimester of pregnancy unless specifically instructed by a healthcare provider, 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 Solves - Aspirin, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)