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, runny nose, sneezing, itching of the nose or throat, and itchy, watery eyes associated with hay fever. Additionally, it temporarily reduces fever.

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

Dosage and Administration

For adults and children aged 12 years and older, the recommended dosage is 2 softgels administered every 6 hours. It is imperative that the total daily dosage does not exceed 8 softgels within a 24-hour period.

For children aged 4 to under 12 years, it is advised to consult a healthcare professional for appropriate dosing recommendations.

The use of this medication is not recommended for children under 4 years of age.

Contraindications

Use of this product is contraindicated in the following situations:

Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, is prohibited 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.

Additionally, this product should not be used in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing an MAOI. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. If there is any doubt about the presence of an MAOI in a patient's medication regimen, a healthcare professional should be consulted prior to use.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 8 softgels within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of 3 or more alcoholic drinks daily while using this product.

Acetaminophen may also trigger severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare professionals should advise patients to consult a physician prior to use if they have any of the following conditions: liver disease, glaucoma, a cough accompanied by excessive phlegm, a persistent or chronic cough associated with smoking, asthma, or emphysema, breathing difficulties such as emphysema or chronic bronchitis, or difficulty urinating due to prostate gland enlargement. Additionally, patients should be cautioned to seek guidance from a doctor or pharmacist if they are currently taking sedatives, tranquilizers, or the anticoagulant warfarin.

In cases of accidental overdose, immediate medical attention is essential. Patients should contact a Poison Control Center or seek emergency medical help without delay, regardless of the presence of symptoms.

Patients are advised to discontinue use and consult a physician if any of the following occur: worsening pain or cough lasting more than 7 days, fever worsening or persisting beyond 3 days, presence of redness or swelling, emergence of new symptoms, or recurrence of cough accompanied by a rash or persistent headache. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed the maximum daily dosage of 8 softgels within 24 hours, use other medications containing acetaminophen concurrently, or consume 3 or more alcoholic drinks daily while using this product.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Common adverse reactions reported during use include marked drowsiness and excitability, particularly in children. The sedative effects may be exacerbated by the concurrent use of alcohol, sedatives, or tranquilizers, and patients are advised to avoid alcoholic beverages while taking this product. Caution is recommended when driving a motor vehicle or operating machinery due to the potential for increased drowsiness.

Patients should discontinue use and consult a healthcare professional if pain or cough 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 with a rash or a persistent headache. These symptoms may indicate a serious underlying condition.

Prior to using this product, patients with liver disease, glaucoma, a cough accompanied by excessive phlegm, a persistent or chronic cough (as seen in smoking, asthma, or emphysema), breathing problems such as emphysema or chronic bronchitis, or difficulty urinating due to prostate enlargement should consult a healthcare provider. Additionally, patients taking sedatives, tranquilizers, or the blood-thinning medication warfarin should seek advice from a doctor or pharmacist before use.

In cases of accidental overdose, it is crucial for patients to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 4 years of age should not use this medication. For children aged 4 to under 12 years, it is advised to consult a healthcare professional before use. In patients 12 years and older, the recommended dosage is 2 softgels every 6 hours, with a maximum of 8 softgels in a 24-hour period.

Caution is warranted as excitability may occur, particularly in children. It is essential to keep this medication out of reach of children. In the event of an accidental overdose, immediate medical assistance should be sought, or a Poison Control Center should be contacted. Prompt medical attention is critical for both adults and children, even if no signs or symptoms are observed.

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 no specific data available regarding the excretion of this medication in 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. The maximum recommended dosage is 8 softgels in a 24-hour period. Exceeding this dosage, taking other medications that contain acetaminophen concurrently, or consuming 3 or more alcoholic drinks daily while using this product may significantly increase the risk of liver injury.

It is advised that patients with a history of liver disease consult a healthcare professional prior to using this product. Monitoring of liver function may be warranted in patients with compromised liver function to ensure safety and efficacy.

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 are advised to remain vigilant and proactive in managing potential overdose situations. Early recognition and treatment can significantly mitigate the risks associated with overdose, ensuring the safety and well-being of the patient.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects. Similarly, no data has been provided concerning non-teratogenic effects. The nonclinical toxicology section does not contain any relevant information at this time. Additionally, there is no information available pertaining to animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions: severe skin reactions, which may manifest 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

Patients should be advised 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.

It is important to inform patients that they should not use this product in conjunction with any other medication containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should consult a doctor or pharmacist.

Patients should be cautioned against using this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) for conditions such as depression, psychiatric or emotional disorders, or Parkinson's disease, or for two weeks after discontinuing an MAOI. If patients are unsure whether their prescription includes an MAOI, they should seek clarification from a healthcare professional.

Patients should be instructed to discontinue use and consult a doctor if their pain or cough worsens or persists for more than seven days, if their fever worsens or lasts more than three days, or if they notice any redness or swelling. Additionally, they should seek medical advice if new symptoms arise or if a cough recurs alongside a rash or a persistent headache, as these may indicate a serious condition.

When using this product, patients may experience significant drowsiness, and excitability may occur, particularly in children. It is advisable to avoid alcoholic beverages while taking this product, as alcohol, sedatives, and tranquilizers can enhance the drowsiness effect. Patients should exercise caution when driving or operating machinery.

Patients should be encouraged to consult a doctor before using this product if they have liver disease, glaucoma, a cough accompanied by excessive phlegm, a persistent or chronic cough associated with smoking, asthma, or emphysema, or any breathing problems such as emphysema or chronic bronchitis. Furthermore, patients experiencing difficulty urinating due to an enlarged prostate gland should also seek medical advice prior to use.

Lastly, patients should be advised to consult a doctor or pharmacist before using this product if they are taking sedatives, tranquilizers, or the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in a blister pack. It is essential to store the product at a temperature range of 68-77°F (20-25°C) to maintain its efficacy. Care should be taken to avoid exposure to excessive heat, which may compromise the integrity of the product. Additionally, the product should not be used if the blister pack is 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)