Sanatos

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of cough and cold symptoms, including cough due to minor throat and bronchial irritation, headache, minor aches and pains, nasal congestion, sinus congestion and pressure, and stuffy nose. Additionally, it temporarily reduces fever.

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

Dosage and Administration

Adults and children aged 12 years and older are advised to take 2 softgels every 4 hours as needed. The total number of doses should not exceed 6 in a 24-hour period.

For children aged 4 to under 12 years, it is recommended to consult a healthcare professional before administration. The use of this medication is not indicated for children under 4 years of age.

It is important to adhere to the specified dosing intervals and not to exceed 4 doses within any 24-hour timeframe to ensure safety and efficacy.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs), which are utilized for the treatment of depression, psychiatric or emotional conditions, or Parkinson's disease, is contraindicated. This includes a prohibition on use for 2 weeks following the discontinuation of an MAOI. If there is uncertainty about whether a prescription medication contains an MAOI, a healthcare professional should be consulted prior to use.

• Exceeding the recommended dosage is also contraindicated.

Warnings and Precautions

This product contains acetaminophen, which carries a significant risk of severe liver damage under certain conditions. Healthcare professionals should advise patients that the maximum recommended dosage is 8 softgels within a 24-hour period. Patients must be cautioned against concurrent use with other medications containing acetaminophen, as well as the consumption of three or more alcoholic drinks daily while using this product.

Acetaminophen may also provoke severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of any skin reaction, patients should be instructed to discontinue use immediately and seek medical assistance.

General precautions should be taken for patients with specific health conditions. Prior to use, patients should consult a healthcare provider if they have a history of liver disease, heart disease, high blood pressure, thyroid disease, diabetes, a cough accompanied by excessive phlegm, a persistent or chronic cough (such as that associated with smoking, asthma, or emphysema), or difficulty urinating due to prostate gland enlargement. Additionally, patients taking the anticoagulant warfarin should seek advice from a doctor or pharmacist before using this product.

In cases of accidental overdose, immediate medical attention is essential. Patients should be advised to contact a Poison Control Center or seek emergency medical help without delay, even if no symptoms are apparent, as prompt intervention is critical for both adults and children.

Patients should also be instructed to discontinue use and consult a healthcare provider if they experience nervousness, dizziness, or sleeplessness; if pain, cough, or nasal congestion worsens or persists beyond 7 days; 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 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 health and allergic reactions. The product contains acetaminophen, which can lead to severe liver damage if the maximum daily limit of 8 softgels is exceeded, if it is taken concurrently with other medications containing acetaminophen, or if consumed with three or more alcoholic drinks daily.

Severe skin reactions have been reported in patients using acetaminophen. Symptoms may include skin reddening, blisters, and rash. In the event of a skin reaction, patients are advised to discontinue use immediately and seek medical assistance.

Patients should stop using the product and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Additionally, worsening pain, cough, or nasal congestion lasting more than 7 days, fever that worsens or persists beyond 3 days, redness or swelling, new symptoms, or a cough that returns or occurs with a rash or headache that lasts may indicate a serious condition requiring medical evaluation.

Before using this product, patients should consult a doctor if they have a history of liver disease, heart disease, high blood pressure, thyroid disease, diabetes, a cough accompanied by excessive phlegm, a persistent or chronic cough associated with smoking, asthma, or emphysema, or difficulty urinating due to prostate gland enlargement. Furthermore, patients taking the blood-thinning medication warfarin should seek advice from a doctor or pharmacist prior to use.

Drug Interactions

Patients taking the anticoagulant warfarin should consult with a healthcare professional, such as a doctor or pharmacist, prior to using this medication. This precaution is necessary to evaluate potential interactions that may affect the efficacy and safety of warfarin therapy.

Currently, there are no additional drug interactions or laboratory test interactions reported for this medication. Therefore, no specific dosage adjustments or monitoring recommendations are provided beyond the consultation for those on warfarin.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 4 to under 12 years should consult a healthcare professional prior to use. The product is contraindicated in children under 4 years of age. For patients aged 12 years and older, the recommended dosage is 2 softgels every 4 hours, with a maximum of 6 doses within a 24-hour period.

Geriatric Use

Elderly patients may not have specific information available 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 potential adverse effects or changes in efficacy, 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 on the excretion of this drug 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 have not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical that patients do not exceed the maximum recommended dosage of 8 softgels in a 24-hour period. Additionally, patients should avoid concurrent use with other medications containing acetaminophen to mitigate the risk of hepatotoxicity.

Patients with compromised liver function are advised to consult a healthcare professional prior to using this product, particularly if they have a history of liver disease. Furthermore, consumption of three or more alcoholic drinks daily while using this product is contraindicated, as it may significantly increase the risk of liver damage. Regular monitoring of liver function may be warranted in patients with existing liver conditions to ensure safety and efficacy during treatment.

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 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 adverse effects. Therefore, vigilance and timely action are essential in managing overdose situations effectively.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions: severe skin reactions, which may present as skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance promptly.

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, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Patients should be informed not to use this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult a doctor or pharmacist.

It is important to instruct patients not to use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI within the past two weeks. Patients should be advised to check with a healthcare professional if they are unsure whether their prescription medication contains an MAOI.

Patients should be counseled to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, they should be advised to stop use and seek medical advice if pain, cough, or nasal congestion worsens or persists for more than seven days, if fever worsens or lasts more than three days, or if any redness or swelling occurs. New symptoms that arise should also prompt a consultation with a healthcare provider.

Patients should be made aware that if a cough returns or occurs alongside a rash or persistent headache, they should seek medical attention, as these may indicate a serious condition. It is essential to emphasize that patients must not exceed the recommended dosage while using this product.

Before using this product, patients should be encouraged to consult a doctor if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, a cough accompanied by excessive phlegm, a persistent or chronic cough associated with smoking, asthma, or emphysema, or difficulty urinating due to an enlarged prostate gland. Furthermore, patients taking the blood-thinning medication warfarin should be advised to consult a doctor or pharmacist prior to use.

Storage and Handling

The product is supplied in blister pack configurations. It is essential to store the product at a temperature range of 68-77°F (20-25°C) to maintain its integrity and efficacy. Care should be taken to avoid exposure to excessive heat, which may compromise the product's quality. Additionally, the product should not be used if the blister pack unit is found to be punctured or torn, as this may indicate potential contamination or degradation.

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)