Sanatos Multi Symptom

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. Specifically, it alleviates cough due to minor throat and bronchial irritation, minor aches and pains, headache, nasal congestion due to hay fever, sore throat, and sinus congestion. Additionally, it aids in loosening phlegm (mucus) and thinning bronchial secretions, thereby making coughs more productive. This drug also temporarily reduces fever.

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

Dosage and Administration

Adults and children 12 years of age and older are advised to take 2 tablets orally every 6 to 8 hours as needed. The total daily dosage should not exceed 8 tablets within a 24-hour period. For children under 12 years of age, it is recommended to consult a healthcare professional for appropriate dosing guidance. It is imperative that the recommended dosage is not exceeded 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, 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.

• The product should not be used 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, or Parkinson's disease. If there is uncertainty about the presence of an MAOI in a prescription medication, a healthcare professional should be consulted prior to use.

Warnings and Precautions

This product contains acetaminophen, which carries a significant risk of severe liver damage if not used according to the specified guidelines. Healthcare professionals should advise patients to adhere strictly to the following precautions:

Liver Warning Severe liver damage may occur if the patient exceeds the maximum daily dosage of 8 tablets within a 24-hour period. Additionally, the risk increases if the product is taken concurrently with other medications containing acetaminophen or if the patient consumes three or more alcoholic drinks daily while using this product.

Allergy Alert Acetaminophen has the potential to cause severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. Should any of these symptoms manifest, patients must discontinue use immediately and seek medical assistance.

Sore Throat Warning In cases of severe sore throat that persists for more than two days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting, patients should be advised to consult a healthcare provider promptly.

Monitoring and Consultation Patients should be instructed to stop use and consult a doctor if they experience any of the following:

• Nervousness, dizziness, or sleeplessness

• Redness or swelling

• Worsening pain or pain that lasts more than seven days

• Worsening fever or fever lasting more than three days

• The emergence of new symptoms

• A persistent cough or symptoms that do not improve within seven days, recur, or are accompanied by fever, rash, or persistent headache. These symptoms may indicate a serious underlying condition.

Overdose Information In the event of an overdose, it is imperative to seek 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.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed the maximum daily dosage of 8 tablets in 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.

Participants should consult a healthcare provider if they experience a severe sore throat that persists for more than 2 days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting.

Patients are advised to stop use and seek medical advice if they experience nervousness, dizziness, or sleeplessness; if redness or swelling occurs; if pain worsens or lasts more than 7 days; if fever worsens or lasts more than 3 days; if new symptoms arise; or if a persistent cough or symptoms do not improve within 7 days, recur, or are accompanied by fever, rash, or persistent headache, as these may indicate a serious condition.

Before using this product, patients with liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or trouble urinating due to an enlarged prostate gland should consult a healthcare provider. Additionally, those with a cough accompanied by excessive phlegm or a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, should also seek medical advice prior to use.

Patients taking the blood-thinning medication warfarin should consult a doctor or pharmacist before using this product.

In cases of 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 if no signs or symptoms are initially apparent.

Drug Interactions

Concurrent use of this medication with other products containing acetaminophen, whether prescription or nonprescription, is contraindicated. Patients should be advised to consult a healthcare professional if there is uncertainty regarding the presence of acetaminophen in any other medications.

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain drugs prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, it should not be used for a period of two weeks following the discontinuation of an MAOI. Patients should seek guidance from a healthcare professional if they are unsure whether their prescription includes an MAOI.

Caution is advised when considering the use of this medication in conjunction with warfarin, a blood-thinning agent. Patients should consult a healthcare professional prior to use to evaluate potential interactions and the need for monitoring.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should consult a doctor before use. For adolescents aged 12 years and older, the recommended dosage is 2 tablets every 6-8 hours, with a maximum of 8 tablets in a 24-hour period.

It is essential to keep this medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, and contacting a Poison Control Center is advised. Prompt medical attention is critical for both adults and children, even if no signs or symptoms are apparent.

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, given the lack of targeted data.

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 healthcare 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 be aware that this product contains acetaminophen, which carries a risk of severe liver damage. It is critical that patients do not exceed the maximum daily dosage of 8 tablets within a 24-hour period. Additionally, patients should avoid the concurrent use of other medications containing acetaminophen and limit alcohol consumption to fewer than 3 drinks per day while using this product.

Before initiating treatment, patients with liver disease are advised to consult a healthcare professional. Monitoring of liver function may be warranted in these patients to ensure safety and efficacy during the course of treatment.

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 observable 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

The available nonclinical study data does not indicate any teratogenic or non-teratogenic effects. Additionally, there is no information regarding animal pharmacology and toxicology. As such, no specific findings related to carcinogenicity or mutagenicity are provided in the available data.

Postmarketing Experience

No postmarketing experience details are available in the insert.

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 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 medication 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. Patients should be advised to ask a healthcare professional if they are unsure whether their prescription includes an MAOI.

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

Patients should be made aware that a persistent cough or symptoms that do not improve within seven days, recur, or are accompanied by fever, rash, or a persistent headache may indicate a serious condition, warranting medical evaluation.

Before using this medication, patients should be advised to consult a doctor if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. Furthermore, patients with a cough that produces excessive phlegm or those with a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, should also seek medical advice prior to use.

Lastly, patients taking the blood-thinning medication warfarin should be encouraged to consult a doctor or pharmacist before using this product.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature, maintaining a range of 59-86°F (15-30°C). Care should be taken to avoid exposure to excessive heat and humidity, as these conditions may compromise the integrity of the product. Additionally, the product must not be used if the packet is open or torn, ensuring that only intact packaging is utilized for safety and efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)