Solves - Aspirin

Description

NDC 62309-777. ZIPPER is a dissolvable oral strip formulation containing 81 mg of aspirin, classified as a nonsteroidal anti-inflammatory drug (NSAID) and utilized as a pain reliever. Each package contains five strips, which are artificially flavored with a wild cherry flavor. The product is designed for quick dissolution and is characterized by its palatable taste, facilitating 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.

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

Dosage and Administration

This medication is to be taken orally. 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 the age of 12, 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 these symptoms arise.

Aspirin, a component of this product, may elicit severe allergic reactions, which can manifest as hives, facial swelling, asthma (wheezing), or shock. Healthcare providers should be prepared to manage such reactions promptly.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe gastrointestinal bleeding. The likelihood of this adverse effect is increased in patients aged 60 years or older, those with a history of stomach ulcers or bleeding disorders, individuals taking anticoagulants or steroid medications, and those consuming three or more alcoholic beverages daily while using this product. Additionally, caution is warranted for patients who take other medications containing NSAIDs, whether prescription or over-the-counter, and for those who exceed the recommended dosage or duration of use.

Healthcare professionals should advise patients to consult a physician prior to use if they have a history of stomach problems, such as heartburn, or if they have conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. Patients taking diuretics or those with asthma or recent tonsillectomy/oral surgery within the past seven days should also seek medical advice before using this product. Furthermore, it is prudent to inquire about any prescription medications the patient may be taking for gout, diabetes, arthritis, or anticoagulation prior to administration.

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 a healthcare provider if they experience any signs of an allergic reaction, symptoms indicative of stomach bleeding (such as feeling faint, vomiting blood, or having bloody or black stools), worsening pain that persists beyond ten days, fever lasting 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.

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 rare but serious illness that can occur in children and teenagers who have or are recovering from chicken pox or flu-like symptoms. Therefore, this product should not be used in these populations. 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.

Aspirin, a component of this product, may cause severe allergic reactions. Symptoms of such reactions can include hives, facial swelling, asthma (wheezing), and shock. 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 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 should be 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 stomach pain that does not improve. Additionally, patients should seek medical advice if pain worsens or persists for more than 10 days, if fever lasts more than 3 days, if redness or swelling is present, if new symptoms occur, 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. It is advisable for patients to provide their healthcare provider with a complete list of all medications they are taking to facilitate appropriate management of any potential interactions.

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. For children under 12 years of age, it is advised to consult a doctor prior to use.

In patients aged 12 years and older, the recommended dosage is 4 to 6 strips every 4 hours, with a maximum of 36 strips in a 24-hour period unless otherwise directed by a healthcare professional.

Healthcare providers should be vigilant for changes in behavior accompanied by nausea and vomiting, as these may indicate the onset of Reye's Syndrome, a rare but serious condition. In such cases, consultation with a doctor is essential.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk for severe stomach bleeding. It is essential for healthcare providers to exercise caution when prescribing this medication to geriatric patients, especially if they have a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, or kidney disease.

Before initiating treatment, healthcare providers should inquire about the presence of any of these conditions in elderly patients, as they may necessitate closer monitoring or alternative therapeutic strategies. The potential for adverse effects, such as gastrointestinal bleeding, should be carefully weighed against the benefits of treatment in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. The use of aspirin during the last trimester of pregnancy is particularly cautioned against, as it may lead to adverse effects on the unborn child 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 prior to 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 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 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 patient safety and therapeutic efficacy.

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 aware that the specific symptoms of an overdose may vary depending on the 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 the specific substance is known, targeted therapies may be employed as indicated.

It is essential for healthcare providers to remain vigilant and act swiftly in the management of overdose situations to ensure optimal patient outcomes.

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

Postmarketing Experience

Serious side effects have been reported voluntarily through various channels, including surveillance programs. Healthcare professionals and patients are encouraged to report any adverse events to the designated contact number provided for this purpose.

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 are allergic 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 more 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.

Patients should be encouraged to 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. They should also inform their healthcare provider if they are taking a diuretic, have asthma, or have undergone a tonsillectomy or oral surgery within the past 7 days. Furthermore, patients should be advised to consult 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. No special handling requirements are noted; however, standard precautions should be observed to ensure optimal storage conditions.

Additional Clinical Information

Patients should take this medication by mouth, accompanied by a full glass of water unless otherwise directed by a clinician. For adults and children aged 12 years and older, the recommended dosage is 4 to 6 strips every 4 hours, with a maximum of 36 strips in a 24-hour period unless instructed differently by a healthcare provider. For children under 12 years of age, consultation with a doctor is advised.

Clinicians should counsel patients regarding the use of this medication during pregnancy or breastfeeding, emphasizing the importance of consulting a health professional before use. It is particularly critical to avoid aspirin during the last trimester of pregnancy unless specifically directed 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)