Sanatos

Description

The product is identified as PDP Sanatos MS Day, with an SPL code of 34089-3.

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms, including minor aches and pains, headache, sore throat, fever, and cough due to minor throat and bronchial irritation.

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

Dosage and Administration

The dosing cup provided with the medication must be used for accurate measurement. Prior to administration, the solution should be shaken well to ensure proper mixing of the ingredients.

For adults and children aged 12 years and older, the recommended dosage is 30 mL every 4 hours. It is important not to exceed 6 doses within a 24-hour period for adults, and 4 doses for children in this age group.

Healthcare professionals should advise patients to read the complete labeling if they are concurrently using other cold or flu products to avoid potential overdosing.

This medication is not recommended for children under 12 years of age.

Contraindications

Use of this product is contraindicated in the following situations:

Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or those who have discontinued MAOI therapy within the past two weeks. The combination may lead to serious interactions. If there is uncertainty regarding the presence of an MAOI in a prescription, consultation with a healthcare professional is advised.

Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, is also contraindicated due to the risk of acetaminophen overdose. If there is doubt about the acetaminophen content in a medication, a healthcare professional should be consulted.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen, under the following circumstances: adults exceeding 6 doses within a 24-hour period, children exceeding 4 doses in the same timeframe, concurrent use with other medications containing acetaminophen, or if an adult consumes 3 or more alcoholic drinks daily while using this product.

In cases of severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, it is imperative to consult a healthcare professional promptly.

Healthcare professionals should advise patients to seek medical guidance prior to use if they have any of the following conditions: a sodium-restricted diet, liver disease, difficulty urinating due to an enlarged prostate gland, a persistent or chronic cough associated with smoking, asthma, or emphysema, a cough that produces excessive phlegm, or if they are a child experiencing pain from arthritis. Additionally, patients taking the anticoagulant warfarin should consult a doctor or pharmacist before using this product.

In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended. Timely medical intervention is crucial for both adults and children, even in the absence of noticeable symptoms.

Patients should discontinue use and contact a healthcare provider if any of the following occur: pain or cough worsens or lasts longer than 5 days in children or 7 days in adults; fever worsens or persists for more than 3 days; redness or swelling is observed; new symptoms develop; or if a cough recurs or is accompanied by a rash or headache that lasts. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Patients using this product should be aware of potential adverse reactions, including serious warnings related to liver damage and severe sore throat symptoms.

Severe liver damage may occur if adults exceed 6 doses within a 24-hour period, which is the maximum daily amount, or if a child takes more than 4 doses in the same timeframe. The risk is further heightened when this product is taken in conjunction with other medications containing acetaminophen or if an adult consumes 3 or more alcoholic drinks daily while using this product.

Patients experiencing a severe sore throat that persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, should consult a healthcare professional promptly.

This product should not be used by individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of stopping such medication. Additionally, it should not be combined with any other drug containing acetaminophen. Patients uncertain about the presence of acetaminophen in their medications are advised to consult a doctor or pharmacist.

Before using this product, patients should seek medical advice if they have a sodium-restricted diet, liver disease, difficulty urinating due to an enlarged prostate, a persistent or chronic cough (such as that associated with smoking, asthma, or emphysema), a cough accompanied by excessive phlegm, or if they are a child experiencing arthritis pain.

Patients taking the blood-thinning medication warfarin should also consult a healthcare professional prior to use.

Patients are advised to discontinue use and seek medical attention if pain or cough worsens or persists beyond 5 days for children or 7 days for adults, if fever worsens or lasts more than 3 days, if redness or swelling occurs, if new symptoms develop, or if a cough recurs or is accompanied by a rash or headache lasting longer than expected. These symptoms may indicate a serious condition requiring medical evaluation.

Drug Interactions

Co-administration of this medication with prescription monoamine oxidase inhibitors (MAOIs), which are utilized for the treatment of depression, psychiatric or emotional conditions, or Parkinson's disease, is contraindicated. The use of this medication is not recommended during treatment with MAOIs or within 2 weeks following the discontinuation of an MAOI.

Additionally, caution is advised when considering the use of this medication in patients who are concurrently taking warfarin, a blood-thinning agent. It is recommended that patients consult with a healthcare professional, such as a doctor or pharmacist, prior to initiating therapy with this medication if they are on warfarin. Monitoring of coagulation parameters may be warranted to ensure patient safety.

Packaging & NDC

Below are the non-prescription pack sizes of Sanatos (acetaminophen, dextromethorphan hbr). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For adolescents aged 12 years and older, the recommended dosage is 30 mL every 4 hours, with a maximum of 4 doses per 24 hours for children and 6 doses for adults.

Healthcare professionals should advise caregivers to discontinue use and consult a doctor if the child's pain or cough worsens or persists beyond 5 days, if fever worsens or lasts more than 3 days, or if any redness or swelling occurs. New symptoms, a returning cough, or a cough accompanied by a rash or headache that lasts should also prompt medical consultation, as these may indicate a serious condition.

It is important to note the liver warning: severe liver damage may occur if a child exceeds 4 doses in a 24-hour period. Additionally, caregivers should seek medical advice before administering this medication to a child with arthritis-related pain.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they experience difficulties with urination due to an enlarged prostate gland. 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 exercise caution when using this product, which contains acetaminophen. It is critical to note that severe liver damage may occur if adults exceed 6 doses within a 24-hour period, which is the maximum daily amount. For children, the risk of severe liver damage increases if more than 4 doses are taken in the same timeframe.

Additionally, patients should be aware that the concurrent use of this product with other medications containing acetaminophen can also lead to severe liver damage. Alcohol consumption further exacerbates this risk; adults who consume 3 or more alcoholic drinks daily while using this product may be at an increased risk for severe liver damage.

It is strongly advised that patients with liver disease consult a healthcare professional prior to using this product to assess the potential risks and determine appropriate usage. Monitoring of liver function may be warranted in patients with compromised liver function to ensure safety and 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 medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, it is essential to monitor the patient closely and provide appropriate care as needed.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients on the importance of seeking immediate medical assistance in the event of an overdose. Patients should be informed to contact a Poison Control Center or seek medical help without delay. It is crucial to emphasize that prompt medical attention is necessary for both adults and children, even if they do not exhibit any signs or symptoms of overdose. This proactive approach can significantly impact the outcome and safety of the patient.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers assigned 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

No further data are available.

Drug Information (PDF)

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

View product document (PDF)