Sanatos X

Description

SANATOS® X is a combination medication formulated for the relief of cough, cold, and sore throat symptoms. It contains the active ingredients acetaminophen, dextromethorphan HBr, guaifenesin, and phenylephrine HCl. This product is indicated for the alleviation of fever, aches and pains, headache, as an expectorant, and as a nasal decongestant. It is intended for use in individuals aged 12 years and older. The product is available in a liquid dosage form, with a volume of 6 fluid ounces (177 mL).

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. Specifically, it alleviates minor aches and pains, headache, sore throat, cough due to minor throat and bronchial irritation, and nasal congestion. Additionally, it helps to loosen phlegm (mucus) and thin bronchial secretions, facilitating drainage of the bronchial tubes and making coughs more productive. This drug also provides temporary relief from a stuffy nose and hay fever symptoms, as well as reducing fever.

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage and administration guidelines. The dosing cup provided with the product should be utilized for accurate measurement.

For adults and children aged 12 years and older, the recommended dose is 20 mL every 4 hours, with a maximum limit of 6 doses within a 24-hour period. It is imperative that patients do not exceed this dosage to avoid potential adverse effects.

This product is contraindicated for use in children under 12 years of age. Healthcare professionals should ensure that this information is communicated clearly to patients and caregivers to prevent misuse.

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.

• In patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric, or emotional conditions, or Parkinson's disease, and for a period of 2 weeks following the discontinuation of the MAOI. This is to prevent potential serious interactions. If there is uncertainty 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 carries significant risks that healthcare professionals must communicate to patients.

Liver Warning Severe liver damage may occur if patients exceed 6 doses within a 24-hour period, which is the maximum recommended daily amount. Caution is advised when this product is taken in conjunction with other medications containing acetaminophen. Additionally, patients who consume 3 or more alcoholic drinks daily while using this product are at increased risk for liver damage.

Allergy Alert Acetaminophen may induce severe skin reactions. Symptoms indicative of an allergic reaction include skin reddening, blisters, and rash. Should any of these symptoms occur, patients must discontinue use immediately and seek medical assistance.

Sore Throat Warning Patients experiencing a severe or persistent sore throat, particularly when accompanied by high fever, headache, nausea, or vomiting, should consult a physician promptly, as these symptoms may indicate a serious condition.

General Precautions Healthcare professionals should advise patients to consult a doctor or pharmacist prior to use if they are currently taking the anticoagulant warfarin. Additionally, patients should seek medical advice before using this product if they have any of the following conditions:

• Liver disease

• High blood pressure

• A cough associated with excessive phlegm (mucus)

• Persistent or chronic cough, such as that which occurs with smoking, asthma, bronchitis, or emphysema

• Difficulty urinating due to prostate gland enlargement

• Heart disease

• Thyroid disease

• Diabetes

Emergency Medical Help In the event of an overdose, it is imperative to seek emergency medical help or contact a Poison Control Center immediately. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are initially apparent.

Discontinuation and Consultation Patients should stop taking this product and contact their healthcare provider if any of the following occur:

• A skin rash develops

• Symptoms persist for more than 7 days, recur, or are accompanied by fever, rash, or persistent headache

• Fever worsens or lasts more than 3 days

• Redness or swelling is observed

• New symptoms arise

• Symptoms of nervousness, dizziness, or sleeplessness occur

These signs may indicate a serious underlying condition that requires medical evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of six doses within a 24-hour period, take the product in conjunction with other medications containing acetaminophen, or consume three 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 an allergic reaction, it is imperative to discontinue use and seek medical assistance immediately.

Severe or persistent sore throat, particularly when accompanied by high fever, headache, nausea, or vomiting, may indicate a serious condition, and patients are advised to consult a physician promptly.

Patients should discontinue use and consult a doctor if they experience a skin rash, if symptoms persist for more than seven days, recur, or are accompanied by fever, rash, or persistent headache. Additionally, if fever worsens or lasts more than three days, if redness or swelling occurs, if new symptoms arise, or if nervousness, dizziness, or sleeplessness develop, these may be signs of a serious condition requiring medical evaluation.

Before using this product, patients should consult a healthcare professional if they have liver disease, high blood pressure, a cough with excessive phlegm, a persistent or chronic cough (such as that associated with smoking, asthma, bronchitis, or emphysema), difficulty urinating due to prostate enlargement, heart disease, thyroid disease, or diabetes.

Furthermore, patients taking the blood-thinning medication warfarin should seek advice from a doctor or pharmacist prior to use.

Drug Interactions

Co-administration of this medication with any other product containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose, which can lead to severe liver damage.

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson's disease. The combination may lead to serious and potentially life-threatening interactions.

Patients taking the anticoagulant warfarin should consult a healthcare professional, such as a doctor or pharmacist, prior to using this medication. Monitoring of coagulation parameters may be necessary to ensure safe use and to avoid potential alterations in the effectiveness of warfarin therapy.

Packaging & NDC

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

Pediatric Use

This product is not intended for use in pediatric patients under 12 years of age. For those 12 years and older, the recommended dosage is 20 mL every 4 hours. It is important to note that children under 12 years should not use this product.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and breastfeeding considerations.

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 have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. It is important to note that severe liver damage may occur if patients exceed 6 doses within a 24-hour period, which is the maximum daily amount. Additionally, the risk of liver damage increases if this product is taken concurrently with other medications containing acetaminophen or if patients consume 3 or more alcoholic drinks daily while using this product.

Patients with liver disease are advised to consult a healthcare professional prior to use to assess the appropriateness of this medication and to discuss potential risks. Monitoring of liver function may be warranted in patients with compromised liver function to ensure safety and efficacy while using this product.

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, regardless of whether any signs or symptoms are apparent.

Healthcare professionals should be aware that the absence of symptoms does not preclude the possibility of serious complications arising from an overdose. 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 compound in these areas.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions associated with acetaminophen use: severe skin reactions, which include skin reddening, blisters, and rash. These events have been reported voluntarily or through surveillance programs.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose, as prompt medical attention is critical for both adults and children, even if no signs or symptoms are initially apparent.

Patients should be informed not to use this medication in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in any other medications, patients are encouraged to consult with a doctor or pharmacist.

It is important to instruct patients not to use this product if they or their child 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 verify 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 a skin rash develops. Additionally, they should be advised to stop use and seek medical advice if symptoms persist for more than seven days, recur, or are accompanied by fever, rash, or a persistent headache. If fever worsens or lasts more than three days, patients should also stop use and contact a healthcare provider. They should be informed to seek medical attention if redness or swelling occurs, if new symptoms arise, or if they experience nervousness, dizziness, or sleeplessness, as these may indicate a serious condition.

Patients with liver disease, high blood pressure, a cough accompanied by excessive phlegm, a persistent or chronic cough (such as that associated with smoking, asthma, bronchitis, or emphysema), difficulty urinating due to prostate enlargement, heart disease, thyroid disease, or diabetes should be advised to consult a doctor before using this medication. Furthermore, patients taking the blood-thinning medication warfarin should also seek guidance from a doctor or pharmacist prior to use.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It is essential to store the product at a temperature range of 59-86°F (15-30°C). Refrigeration is not recommended, as the product should not be exposed to temperatures outside this specified range. Proper handling and storage conditions must be adhered to in order to maintain product integrity and efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

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