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Sanatos Multi Symptom Daytime

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Active ingredients
  • Acetaminophen 325 mg/15 mL
  • Dextromethorphan Hydrobromide 10 mg/15 mL
  • Phenylephrine Hydrochloride 5 mg/15 mL
Other brand names
Drug classes
Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist, alpha-1 Adrenergic Agonist
Dosage form
Liquid
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2014
Label revision date
November 17, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Acetaminophen 325 mg/15 mL
  • Dextromethorphan Hydrobromide 10 mg/15 mL
  • Phenylephrine Hydrochloride 5 mg/15 mL
Other brand names
Drug classes
Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist, alpha-1 Adrenergic Agonist
Dosage form
Liquid
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 2014
Label revision date
November 17, 2023
Manufacturer
Pharmadel LLC
Registration number
M013
NDC root
55758-055
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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Drug Overview

This medication is designed to temporarily relieve common cold and flu symptoms, helping you feel more comfortable when you're under the weather. It can alleviate minor aches and pains, headaches, sore throats, fevers, nasal congestion, and coughs caused by minor throat and bronchial irritation.

By addressing these symptoms, the drug aims to make your experience with a cold or flu more manageable, allowing you to focus on recovery.

Uses

If you're dealing with the discomfort of a common cold or flu, this medication can help temporarily relieve your symptoms. You can expect relief from minor aches and pains, headaches, sore throats, fever, nasal congestion, and cough caused by minor irritation in your throat and bronchial area.

It's important to note that this medication does not have any known teratogenic effects, meaning it does not cause developmental issues in a fetus. Similarly, there are no reported nonteratogenic effects, ensuring a focus on your immediate relief from cold and flu symptoms.

Dosage and Administration

It's important to take this medication exactly as recommended to avoid any risks, including overdose. You should use a dosage cup or tablespoon (TBSP) for accurate measurement. Remember, you should not exceed 4 doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dose is 30 mL (which is 2 TBSP) every 4 hours. If your child is between 6 and 12 years old, they should take 15 mL (1 TBSP) every 4 hours. For children aged 4 to under 6 years, it's best to consult a doctor before giving any medication. If your child is under 4 years old, do not use this medication at all.

If you are using both daytime and nighttime products, be sure to read each label carefully to ensure you are dosing correctly.

What to Avoid

You should avoid using this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication used for depression, psychiatric conditions, or Parkinson's disease. Additionally, do not use it for at least two weeks after stopping an MAOI. If you're unsure whether your medication contains an MAOI, please consult your doctor or pharmacist.

It's also important not to combine this product with any other medications that contain acetaminophen, whether they are prescription or over-the-counter. If you have any doubts about the ingredients in your medications, ask a healthcare professional. Lastly, avoid consuming alcoholic drinks while using this product, and always follow the dosing instructions carefully to prevent any risk of overdose.

Side Effects

This product contains acetaminophen, which can lead to severe liver damage if you exceed 4,000 mg in 24 hours or if you take it alongside other medications containing acetaminophen. It's also important to avoid using this product if you consume three or more alcoholic drinks daily. Additionally, be aware that acetaminophen may cause serious skin reactions, such as skin reddening, blisters, or rashes. If you notice any of these symptoms, stop using the product and seek medical help immediately.

You should also consult a doctor if you experience nervousness, dizziness, or sleeplessness, or if new symptoms arise. If a sore throat is severe, lasts more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, seek medical attention. Other signs to watch for include worsening fever lasting more than three days, increasing pain or cough lasting longer than five days for children or seven days for adults, or any redness or swelling. These could indicate a more serious condition.

Warnings and Precautions

This product contains acetaminophen, which can lead to severe liver damage if you take more than 4,000 mg in 24 hours or if a child takes more than 5 doses in the same timeframe. Be cautious if you consume three or more alcoholic drinks daily while using this product, as this increases the risk of liver issues. Additionally, acetaminophen may cause serious skin reactions, such as redness, blisters, or rashes. If you experience any of these symptoms, stop using the product and seek medical help immediately. If you have a severe sore throat that lasts more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, consult your doctor promptly.

Before using this product, it's important to talk to your doctor if you have any existing health conditions, such as liver disease, heart disease, thyroid disease, diabetes, high blood pressure, or issues with urination due to an enlarged prostate. If you experience symptoms like nervousness, dizziness, sleeplessness, or if new symptoms arise, stop taking the product and contact your doctor. Seek emergency medical help if you suspect an overdose, even if you don't notice any symptoms, as quick attention is crucial for both adults and children.

Overdose

If you suspect an overdose, it’s important to seek medical help immediately or contact a Poison Control Center. Quick medical attention 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 the outcome.

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

When it comes to giving this medication to children, it's important to follow specific guidelines. For children aged 6 years to under 12 years, the recommended dose is 15 mL (which is about 1 tablespoon) every 4 hours. If your child is between 4 years and under 6 years, you should consult a doctor before administering the medication. It is crucial to avoid using this medication for children under 4 years of age.

Additionally, be aware of the overdose warning: if you suspect your child has taken too much, seek medical help immediately, even if they don't show any signs or symptoms. Your child's safety is the top priority, so always follow these recommendations closely.

Geriatric Use

While there is no specific information about how this medication should be used by older adults, it's important to approach any new treatment with caution. If you or a loved one is an older adult, it's wise to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so regular check-ins with your doctor can ensure safety and effectiveness.

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication, especially if you experience difficulty urinating due to an enlarged prostate gland. Your healthcare provider can help determine if this medication is safe for you and may suggest adjustments to your dosage or additional monitoring to ensure your safety. Always prioritize open communication with your doctor regarding your kidney health and any concerns you may have.

Hepatic Impairment

If you have liver problems, it's important to be cautious when using products that contain acetaminophen. Taking more than 4,000 mg in a 24-hour period can lead to severe liver damage. This risk increases if you consume three or more alcoholic drinks daily while using the product or if you take other medications that also contain acetaminophen. For children, giving more than five doses in a day can also be harmful.

Before using this product, you should consult with your doctor, especially if you have liver disease. While using it, it's best to avoid alcohol altogether to protect your liver health.

Drug Interactions

It's important to be cautious when taking this medication, especially if you are currently using or have recently stopped a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication often used for depression or certain psychiatric conditions. You should avoid using this product while on an MAOI or for two weeks after stopping it. If you're unsure whether your current medication includes an MAOI, please consult your doctor or pharmacist.

Additionally, you should not take this medication alongside any other products that contain acetaminophen, which is a common pain reliever found in many over-the-counter and prescription drugs. If you have any doubts about whether a medication contains acetaminophen, it's best to check with a healthcare professional. Always discuss your medications and any potential interactions with your healthcare provider to ensure your safety and well-being.

Storage and Handling

To ensure the best performance of your product, store it at room temperature. This means keeping it in a place that is neither too hot nor too cold, typically between 68°F and 77°F (20°C to 25°C).

When handling the product, make sure to do so with clean hands and in a clean environment to maintain its safety and effectiveness. Always follow any specific instructions provided with the product for optimal use.

Additional Information

No further information is available.

FAQ

What symptoms does this drug temporarily relieve?

This drug temporarily relieves common cold and flu symptoms, including minor aches and pains, headache, sore throat, fever, nasal congestion, and cough due to minor throat and bronchial irritation.

What is the recommended dosage for adults and children over 12?

Adults and children 12 years and over should take 30 mL (2 tablespoons) every 4 hours.

What should children aged 6 to under 12 take?

Children aged 6 years to under 12 years should take 15 mL (1 tablespoon) every 4 hours.

Are there any contraindications for this drug?

Do not use this drug if you are taking a prescription monoamine oxidase inhibitor (MAOI) or if you are using any other drug containing acetaminophen.

What should I do if I experience severe skin reactions?

If you experience severe skin reactions such as reddening, blisters, or rash, stop use and seek medical help immediately.

What should I do in case of overdose?

In case of overdose, get medical help or contact a Poison Control Center right away, as quick medical attention is critical.

Can I use this drug if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before using this drug.

What precautions should I take regarding alcohol?

Avoid alcoholic drinks while using this product, as it may increase the risk of severe liver damage.

What should I do if my symptoms worsen or new symptoms occur?

Stop use and consult a doctor if you experience new symptoms, or if your fever, pain, or cough worsens or lasts longer than the recommended duration.

Packaging Info

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

Packaging configurations for Sanatos Multi Symptom Daytime.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is identified by the SPL Code 34089-3. No specific description details are provided in the text.

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, fever, nasal congestion, and cough due to minor throat and bronchial irritation.

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

Dosage and Administration

The medication should be taken only as recommended, adhering to the overdose warning. A dosage cup or tablespoon (TBSP) should be utilized for accurate measurement. It is imperative not to exceed 4 doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is 30 mL (2 TBSP) every 4 hours. For children aged 6 years to under 12 years, the dosage is 15 mL (1 TBSP) every 4 hours. For children aged 4 years to under 6 years, it is advised to consult a physician before administration. The medication is not recommended for children under 4 years of age.

When utilizing both daytime and nighttime formulations, healthcare professionals should ensure that each label is carefully read to confirm the correct dosing.

Contraindications

Use of this product is contraindicated in the following situations:

Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or those who have discontinued MAOI therapy within the past two weeks. The combination may lead to serious interactions. If there is uncertainty regarding the presence of an MAOI in a prescription, consultation with a healthcare professional is advised.

Concurrent use with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose. If there is doubt about the acetaminophen content of a medication, a healthcare professional should be consulted.

Additionally, the product should not be used in excess of the recommended dosage, as this may lead to overdose.

Warnings and Precautions

This product contains acetaminophen, which carries significant risks for liver damage. Severe liver injury may occur if adults exceed 4,000 mg of acetaminophen within a 24-hour period, if a child takes more than five doses in 24 hours, if it is used concurrently with other medications containing acetaminophen, or if an adult consumes three or more alcoholic beverages daily while using this product.

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

Healthcare professionals should advise patients to consult a physician prior to using this product if they have any of the following conditions: liver disease, heart disease, thyroid disease, diabetes, high blood pressure, difficulty urinating due to an enlarged prostate gland, or a persistent or chronic cough associated with smoking, asthma, or emphysema. Additionally, patients with a cough that produces excessive phlegm should also seek medical advice before use.

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

Patients should be advised to discontinue use and consult a healthcare provider if they experience any of the following: nervousness, dizziness, or sleeplessness; the emergence of new symptoms; worsening fever lasting more than three days; worsening pain or cough lasting more than five days in children or seven days in adults; the presence of redness or swelling; or a cough that recurs or is accompanied by a rash or headache that persists. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Patients using this product should be aware of several potential adverse reactions, which can range from serious to common.

Severe liver damage is a significant concern associated with the use of this product, particularly due to its acetaminophen content. This risk is heightened if adults exceed 4,000 mg of acetaminophen within a 24-hour period, if a child takes more than five doses in the same timeframe, if the product is taken concurrently with other medications containing acetaminophen, or if an adult consumes three or more alcoholic drinks daily while using this product.

Additionally, there is an allergy alert regarding the potential for severe skin reactions related to acetaminophen. Symptoms may include skin reddening, blisters, and rash. Should any skin reaction occur, patients are advised to discontinue use immediately and seek medical assistance.

Patients should also be vigilant for signs of a severe sore throat, particularly if it persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting. In such cases, prompt consultation with a healthcare provider is recommended.

Common adverse reactions that warrant discontinuation of use and consultation with a doctor include feelings of nervousness, dizziness, or sleeplessness, the emergence of new symptoms, worsening fever lasting more than three days, or pain and cough that persist beyond five days in children or seven days in adults. Redness or swelling, as well as a cough that recurs or occurs alongside a rash or headache lasting for an extended period, should also prompt medical evaluation, as these may indicate a serious underlying condition.

Drug Interactions

The concomitant use of this product with monoamine oxidase inhibitors (MAOIs) is contraindicated. MAOIs are typically prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Patients should not initiate treatment with this product while currently taking an MAOI or within 2 weeks of discontinuing an MAOI. It is advisable for patients to consult a healthcare professional if there is uncertainty regarding the presence of an MAOI in their prescription medications.

Additionally, this product should not be used in conjunction with any other medications that contain acetaminophen, whether prescription or nonprescription. Patients are encouraged to verify the ingredients of their medications with a healthcare provider or pharmacist if there is any doubt about the presence of acetaminophen.

Packaging & NDC

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

Packaging configurations for Sanatos Multi Symptom Daytime.
Details

Pediatric Use

Pediatric patients aged 6 years to under 12 years may receive a dosage of 15 mL (1 tablespoon) every 4 hours. For children aged 4 years to under 6 years, it is advised to consult a healthcare professional before administration. The use of this medication is not recommended for children under 4 years of age.

In the event of an overdose, it is crucial to seek immediate medical attention for pediatric patients, 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.

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 maternal health. Healthcare providers should consider the individual circumstances of each patient when making recommendations.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on 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 adults do not exceed 4,000 mg of acetaminophen within a 24-hour period, and children should not take more than 5 doses in the same timeframe. Additionally, patients must be aware of the potential for liver damage when this product is taken in conjunction with other medications containing acetaminophen.

Patients with a history of liver disease are advised to consult a healthcare professional prior to using this product. Furthermore, it is recommended that patients avoid the consumption of alcoholic beverages while using this product, as the combination of acetaminophen and alcohol can significantly increase the risk of liver injury. Regular monitoring of liver function may be warranted in patients with compromised liver function to ensure safety and efficacy during 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 are advised to remain vigilant and proactive in managing potential overdose situations. The lack of immediate symptoms does not preclude the possibility of serious health consequences, and therefore, timely evaluation and treatment are essential.

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 keep this and all medications out of reach of children to prevent accidental ingestion. Patients should be informed not to use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of stopping such medication. If patients are uncertain whether their prescription includes an MAOI, they should be encouraged to consult with their doctor or pharmacist.

It is important to instruct patients not to use this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. Patients should be reminded to verify the presence of acetaminophen in their other medications by consulting a healthcare professional if they are unsure.

Patients should be counseled to discontinue use and seek medical advice if they experience nervousness, dizziness, or sleeplessness. Additionally, they should be advised to stop using the product and consult a doctor if new symptoms arise, if fever worsens or persists beyond three days, or if pain or cough intensifies or lasts longer than five days in children or seven days in adults. Patients should also be informed to seek medical attention if they notice any redness or swelling, or if a cough recurs or is accompanied by a rash or persistent headache, as these may indicate a serious condition.

When using this product, patients must be cautioned against exceeding the recommended dosage and to avoid consuming alcoholic beverages. It is essential for patients to consult a doctor before using this product if they have any of the following conditions: liver disease, heart disease, thyroid disease, diabetes, high blood pressure, or difficulty urinating due to an enlarged prostate gland. Furthermore, patients should be advised to seek medical advice if they have a persistent or chronic cough associated with smoking, asthma, or emphysema, or if their cough is accompanied by excessive phlegm.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature to maintain its integrity and efficacy. No special handling requirements are noted, ensuring straightforward management within standard storage conditions.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Sanatos Multi Symptom Daytime, 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 Multi Symptom Daytime, 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.

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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.