Sanatos Severe Cold and Cough Day Time

Description

No description information is available for the drug.

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, headache, sore throat, minor aches and pains, nasal congestion due to hay fever, other upper respiratory allergies, sinus congestion and pressure, and stuffy nose. Additionally, it is effective in reducing fever.

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

Dosage and Administration

The recommended dosage for adults and children aged 12 years and older is one packet every 4 hours, with a maximum of 6 packets within a 24-hour period. It is imperative not to exceed the recommended dosage.

To prepare the solution, the contents of one packet should be dissolved in 8 ounces of hot water. The mixture should be sipped while hot, and the entire drink should be consumed within 10 to 15 minutes for optimal effectiveness.

If utilizing a microwave for preparation, the contents of one packet should be added to 8 ounces of cool water. The solution must be stirred briskly before and after heating to ensure proper dissolution. Care should be taken to avoid overheating the mixture.

This product is not recommended for use in children under 12 years of age.

Contraindications

Use of this product is contraindicated in the following situations:

• Concurrent use with any other drug containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare professional is advised.

• Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric or emotional conditions, or Parkinson's disease, or within 2 weeks of discontinuing such medication. Verification of MAOI content in prescription drugs should be sought from a healthcare professional if uncertain.

• Use is limited to a maximum of 7 days for pain relief and 3 days for fever, unless otherwise directed by a healthcare provider.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the maximum daily dosage of 6 packets is exceeded within a 24-hour period. Additionally, liver damage may occur if acetaminophen is taken concurrently with other medications containing acetaminophen or if the product is used while consuming three or more alcoholic drinks daily.

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 doctor before using this product 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 anticoagulant warfarin should seek guidance from a doctor or pharmacist prior to use.

In cases of accidental overdose, immediate medical attention is crucial. Patients should contact a Poison Control Center or seek emergency medical help without delay, even if no symptoms are apparent.

Patients are advised to discontinue use and consult a doctor if any of the following occur: a persistent cough or symptoms that do not improve within 5 days, recurrence of symptoms, the presence of fever, rash, or persistent headache, the emergence of new symptoms, redness or swelling, or experiences of nervousness, dizziness, or sleeplessness. These may indicate a serious underlying condition that requires further evaluation.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur with the use of this product, particularly if patients exceed the maximum daily amount of six packets within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

Additionally, acetaminophen may cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. If any of these symptoms occur, patients are advised to discontinue use immediately and seek medical assistance.

Patients should also be cautious if they experience a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, as these may indicate a serious condition requiring prompt medical consultation.

It is recommended that patients stop use and consult a doctor if they experience a persistent cough or if symptoms do not improve within five days, recur, or are accompanied by fever, rash, or persistent headache. New symptoms, redness, or swelling should also prompt a consultation. Symptoms such as nervousness, dizziness, or sleeplessness may warrant medical advice as well.

Patients with pre-existing conditions should seek medical advice before using this product if they have liver disease, heart disease, high blood pressure, thyroid disease, diabetes, a cough with excessive phlegm, a persistent or chronic cough (as seen in smoking, asthma, or emphysema), or difficulty urinating due to an enlarged prostate gland.

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

In the event of an accidental overdose, it is critical 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

There are currently no documented drug interactions associated with this medication. Additionally, there are no known 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 Severe Cold and Cough Day Time (acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For adults and children aged 12 years and older, the recommended dosage is one packet every 4 hours.

Healthcare professionals should advise caregivers to keep this medication out of reach of children. In the event of an accidental overdose, it is crucial 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.

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 healthcare professional prior to using this medication. There is currently no available data regarding 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 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, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical that patients do not exceed the maximum daily amount of 6 packets within a 24-hour period. Additionally, patients should avoid concomitant use with other medications containing acetaminophen, as this may further increase the risk of liver injury.

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 per day while using this product is not recommended, as it may exacerbate 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 attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that early intervention can significantly impact the outcome of an overdose situation. Therefore, it is recommended to maintain a proactive approach in managing potential overdose cases.

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 nonclinical toxicology section does not provide any data on carcinogenicity or mutagenicity.

Postmarketing Experience

Acetaminophen has been associated with severe skin reactions reported in postmarketing experience. Symptoms of these reactions may include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an accidental overdose, patients should be instructed to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is critical for both adults and children, even if no signs or symptoms are present.

Patients should be cautioned against using 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 inform patients that this medication should not be used if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of stopping an MAOI. Patients should be advised to check with a healthcare professional if they are unsure whether their prescription medication contains an MAOI.

Patients should be instructed not to use this medication for more than seven days for pain relief or three days for fever, unless directed by a healthcare provider. They should be advised to stop use and consult a doctor if a persistent cough or symptoms do not improve within five days, recur, or are accompanied by fever, rash, or a persistent headache, as these may indicate a serious condition.

Patients should also be informed to discontinue use and seek medical advice if new symptoms arise, or if they experience redness or swelling. Additionally, they should be made aware that nervousness, dizziness, or sleeplessness may occur, and they should stop use and consult a doctor if these symptoms develop.

Before using this medication, patients should be encouraged to consult a healthcare provider 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 seek guidance from a doctor or pharmacist before use.

Storage and Handling

The product is supplied in packets that must be stored at room temperature, specifically within the range of 68-77°F (20-25°C). It is essential to protect the packets from excessive heat and moisture to maintain product integrity. Healthcare professionals should ensure that the packets are not used if they are broken or torn, as this may compromise the product's safety and efficacy.

Additional Clinical Information

The medication is administered orally, with a recommended frequency of every 4 hours, not to exceed 6 packets within a 24-hour period. Clinicians should advise patients who are pregnant or breastfeeding to consult a healthcare professional prior to use. It is crucial to keep the medication out of reach of children. In the event of an accidental overdose, patients should seek medical assistance or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even if no symptoms are apparent.

Drug Information (PDF)

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

View product document (PDF)