Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Sanatos

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredients
  • Acetaminophen 325 mg
  • Dextromethorphan Hydrobromide 10 mg
  • Phenylephrine Hydrochloride 5 mg
Other brand names
Dosage form
Capsule, Liquid Filled
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2023
Label revision date
August 11, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Acetaminophen 325 mg
  • Dextromethorphan Hydrobromide 10 mg
  • Phenylephrine Hydrochloride 5 mg
Other brand names
Dosage form
Capsule, Liquid Filled
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2023
Label revision date
August 11, 2025
Manufacturer
Pharmadel LLC
Registration number
M012
NDC root
55758-041
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

Sanatos Daytime is a medication designed to temporarily relieve symptoms associated with coughs and colds. It helps alleviate discomfort caused by minor throat and bronchial irritation, headaches, minor aches and pains, nasal and sinus congestion, and stuffy noses. Additionally, it can temporarily reduce fever, making it a supportive option when you're feeling under the weather.

Uses

If you're dealing with a cough or cold, this medication can help provide temporary relief from various symptoms. It can ease your cough caused by minor irritation in your throat and bronchial tubes, as well as alleviate headaches, minor aches and pains, and nasal congestion. If you're feeling pressure in your sinuses or have a stuffy nose, this medication can also help with that. Additionally, it can temporarily reduce fever, making you feel more comfortable while you recover.

Dosage and Administration

When taking this medication, it's important to follow the recommended dosage to ensure safety and effectiveness. For adults and children aged 12 years and older, you should take 2 softgels every 6 hours, but make sure not to exceed 4 doses in a 24-hour period.

If you have children between the ages of 4 and under 12 years, it's best to consult a doctor before giving them this medication. For children under 4 years old, you should not use this medication at all. Always remember to adhere to these guidelines to help manage your health safely.

What to Avoid

You should avoid using this product if you are currently taking any other medication that contains acetaminophen, whether it's a prescription or over-the-counter drug. If you're unsure whether a medication has acetaminophen, please consult your doctor or pharmacist. Additionally, do not use this product if you are taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric conditions, or Parkinson's disease, or for two weeks after stopping an MAOI. Again, if you're uncertain about your medications, it's best to ask a healthcare professional.

While using this product, it's crucial that you do not exceed the recommended dosage. Misusing or abusing this medication can lead to serious health issues, including dependence (a condition where your body becomes reliant on a substance). Always prioritize your safety and well-being by following these guidelines.

Side Effects

This product contains acetaminophen, which can lead to severe liver damage if you exceed 8 softgels in 24 hours, take it with other acetaminophen-containing medications, or consume 3 or more alcoholic drinks daily while using it. Additionally, be aware that acetaminophen may cause serious skin reactions, including skin reddening, blisters, or rash. If you notice any of these symptoms, stop using the product and seek medical help immediately.

You should also stop using this product and consult a doctor if you experience nervousness, dizziness, sleeplessness, worsening pain, cough, nasal congestion lasting more than 7 days, fever lasting more than 3 days, or if new symptoms develop. It's important to talk to your doctor before using this product if you have liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or a chronic cough. If you are taking the blood thinner warfarin, consult your doctor or pharmacist before use.

Warnings and Precautions

This product contains acetaminophen, which can lead to severe liver damage if you take more than 8 softgels in 24 hours, use it with other medications containing acetaminophen, or consume 3 or more alcoholic drinks daily while using it. Be aware that acetaminophen may also cause serious skin reactions, such as skin reddening, blisters, or rash. If you experience any of these symptoms, stop using the product and seek medical help immediately.

Before using this product, consult your doctor if you have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, a cough with excessive mucus, a persistent cough from smoking or asthma, or difficulty urinating due to an enlarged prostate. If you are taking the blood thinner warfarin, check with your doctor or pharmacist before use.

If you accidentally take too much, seek emergency medical help or contact a Poison Control Center right away, even if you don’t notice any symptoms. Additionally, stop using the product and call your doctor if you experience nervousness, dizziness, or sleeplessness, if your pain or cough worsens or lasts more than 7 days, if your fever lasts more than 3 days, or if you notice any new symptoms. These could indicate a more serious condition.

Overdose

If you suspect an accidental overdose, it’s important to seek medical help immediately or contact a Poison Control Center. This is crucial for both adults and children, even if you don’t see any signs or symptoms of an overdose.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Remember, acting quickly can make a significant difference in ensuring safety and health.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

If you have a child aged 4 to under 12 years, it's important to consult a doctor before using this medication. For children under 4 years old, you should not use this product at all. For adults and children aged 12 and older, the recommended dosage is 2 softgels every 6 hours, but you should not exceed 4 doses in a 24-hour period.

Always keep this medication out of reach of children. In the event of an accidental overdose, seek medical help or contact a Poison Control Center immediately, as prompt attention is crucial for both adults and children, even if there are no noticeable symptoms.

Geriatric Use

As an older adult or caregiver, it's important to be aware of certain health considerations when using this medication. While there are no specific dosage adjustments or safety concerns noted for elderly patients, you should always consult a doctor before starting the medication, especially if you have any existing health issues. This includes conditions like liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate.

Taking these precautions can help ensure that the medication is safe and effective for you. Always keep your healthcare provider informed about your health status and any other medications you may be taking.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help monitor your kidney function and make any necessary adjustments to your treatment plan.

Hepatic Impairment

If you have liver problems, it's important to be cautious when using this product, as it contains acetaminophen. Taking more than 8 softgels in a 24-hour period can lead to severe liver damage. This risk increases if you are also taking other medications that contain acetaminophen or if you consume 3 or more alcoholic drinks each day while using this product.

Before using this product, please consult your doctor if you have liver disease. They can provide guidance on safe usage and any necessary adjustments to your dosage. Your health and safety are the top priority, so don’t hesitate to seek professional advice.

Drug Interactions

It's important to talk to your doctor or pharmacist before using this medication, especially if you are taking warfarin, a blood-thinning drug. Combining it with acetaminophen could increase your risk of bleeding, which is a serious concern.

Always discuss any medications you are currently taking with your healthcare provider to ensure your safety and avoid potential interactions. Your health is a priority, and open communication with your medical team is key to effective treatment.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 68-77°F (20-25°C). It's important to avoid exposing it to excessive heat, as this can affect its effectiveness.

When handling the product, be sure to check the blister pack unit before use. If you notice that it is punctured or torn, do not use the product, as this could compromise its safety and effectiveness. Following these guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is Sanatos Daytime used for?

Sanatos Daytime is used to temporarily relieve cough-cold symptoms, including cough due to minor throat and bronchial irritation, headache, minor aches and pains, nasal and sinus congestion, stuffy nose, and to temporarily reduce fever.

What is the recommended dosage for adults and children 12 years and older?

Adults and children 12 years and older should take 2 softgels every 6 hours, not exceeding 4 doses in a 24-hour period.

Can children under 4 years use Sanatos Daytime?

No, Sanatos Daytime should not be used in children under 4 years. For children aged 4 to under 12 years, consult a doctor before use.

What should I do if I experience a skin reaction?

If you experience symptoms like skin reddening, blisters, or rash, stop using Sanatos Daytime and seek medical help immediately.

What are the liver warnings associated with Sanatos Daytime?

Sanatos Daytime contains acetaminophen, which can cause severe liver damage if you take more than 8 softgels in 24 hours, use it with other acetaminophen-containing drugs, or consume 3 or more alcoholic drinks daily while using this product.

What should I do in case of an accidental overdose?

In case of accidental overdose, seek medical help or contact a Poison Control Center immediately, as prompt medical attention is critical.

Are there any specific precautions for people with certain health conditions?

Yes, consult a doctor before use if you have liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to prostate enlargement.

Is it safe to use Sanatos Daytime while pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before using Sanatos Daytime.

How should I store Sanatos Daytime?

Store Sanatos Daytime between 68-77°F (20-25°C) and avoid excessive heat. Do not use if the blister pack is punctured or torn.

Packaging Info

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

Packaging configurations for Sanatos.
Details

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)

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 6 hours as needed. It is important not to exceed 4 doses within a 24-hour period. For children aged 4 to under 12 years, consultation with a healthcare professional is recommended prior to administration. The use of this medication is not indicated 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.

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. Verification of the presence of an MAOI in any prescription medication should be conducted with a healthcare professional prior to use.

Additionally, it is essential to adhere to the recommended dosage, as exceeding this may lead to adverse effects.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 8 softgels in 24 hours (the maximum daily dosage), concomitant 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, heart disease, high blood pressure, thyroid disease, diabetes, a cough accompanied by excessive phlegm (mucus), a persistent or chronic cough associated with smoking, asthma, or emphysema, or difficulty urinating due to prostate gland enlargement. Additionally, patients taking the anticoagulant warfarin should seek guidance from a doctor or pharmacist before using this product.

In cases of accidental overdose, immediate medical attention is crucial. Patients should contact a Poison Control Center or seek emergency medical help, regardless of whether signs or symptoms are present, as prompt intervention is essential for both adults and children.

Patients are advised 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 arise; 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 skin reactions.

Severe liver damage may occur if patients exceed the maximum recommended dosage of 8 softgels in a 24-hour period, take this product in conjunction with other medications containing acetaminophen, 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. 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. Other concerning symptoms include worsening pain, cough, or nasal congestion lasting more than 7 days; fever that worsens or persists for more than 3 days; redness or swelling; the emergence of new symptoms; or a cough that recurs or is accompanied by a rash or headache lasting for an extended period. These symptoms may indicate a serious underlying condition.

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 associated with excessive phlegm, a persistent or chronic cough (such as that seen in 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 blood-thinning medication warfarin should consult a healthcare professional prior to using acetaminophen. The combination may increase the risk of bleeding due to a potential interaction between these two agents. It is advisable to monitor coagulation parameters closely if these medications are used concurrently.

No additional drug interactions or laboratory test interactions have been identified.

Packaging & NDC

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

Packaging configurations for Sanatos.
Details

Pediatric Use

Pediatric patients aged 4 to under 12 years should consult a healthcare professional before use. The product is not recommended for children under 4 years of age. For adults and children aged 12 years and older, the recommended dosage is 2 softgels every 6 hours, with a maximum of 4 doses within a 24-hour period.

It is essential to keep this product out of reach of children. In the event of an accidental overdose, immediate medical assistance should be sought, or contact a Poison Control Center without delay. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Geriatric Use

Elderly patients may not require specific dosage adjustments or exhibit unique safety concerns based on the available data. However, it is essential for healthcare providers to exercise caution and consider the overall health status of geriatric patients prior to prescribing.

It is recommended that healthcare providers consult with a physician before initiating treatment in elderly patients who have underlying conditions such as liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or urinary difficulties due to prostate gland enlargement. These conditions may influence the safety and efficacy of the treatment in this population. Regular monitoring and assessment of these factors are advised to ensure optimal therapeutic outcomes.

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 lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

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 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 of other medications containing acetaminophen and limit alcohol consumption to fewer than 3 alcoholic drinks daily while using this product.

Before initiating treatment, patients with known 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 therapy.

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 are advised to remain vigilant and proactive in managing potential overdose situations. Early intervention can significantly impact the outcome, making it essential to act swiftly and follow established protocols for overdose management.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional before use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has revealed reports of severe skin reactions associated with acetaminophen. These reactions include symptoms such as skin reddening, blisters, and rash. These events have been reported voluntarily or identified 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 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 about the presence of acetaminophen in their medications, 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 using the product 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 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 prostate gland enlargement. Furthermore, patients taking the blood-thinning medication warfarin should also seek advice from 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 efficacy. Care should be taken to avoid exposure to excessive heat, which may compromise the product's integrity. Additionally, the product should not be used if the blister pack unit is found to be punctured or torn, as this may indicate 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)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Sanatos, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

Last AI update:

Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.