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Amino Acid Fragrancemouthwash Dawn

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredient
Sodium Fluoride 0.005 g/10 mL
Other brand names
Dosage form
Liquid
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2020
Label revision date
October 19, 2020
Active ingredient
Sodium Fluoride 0.005 g/10 mL
Other brand names
Dosage form
Liquid
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2020
Label revision date
October 19, 2020
Manufacturer
Shanghai Centro Network Technology Co. , Ltd.
Registration number
part355
NDC root
55409-002

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Drug Overview

This medication is designed for oral use, specifically to be gargled. You should use a 10ml dose at a time, gargling for 30 seconds before spitting it out. It is important to note that you do not need to rinse your mouth with water after using it. This product is typically used to help soothe the throat and may provide relief from discomfort.

Uses

You can use this product to help with oral hygiene. Simply take 10 ml, gargle for 30 seconds, and then spit it out. There's no need to rinse your mouth with water afterward.

It's important to note that this product has not been shown to cause any teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects. This makes it a safe option for maintaining your oral health.

Dosage and Administration

To ensure the effectiveness of your medication, it's important to store it properly. Keep it in a cool and dry place, away from direct sunlight. This helps maintain the medication's quality and ensures that it works as intended when you need it. Always check the storage instructions on the packaging to make sure you're taking the best care of your medication.

What to Avoid

It's important to follow specific guidelines when using this medication. First and foremost, you should not swallow it. This is a crucial instruction to ensure your safety and the effectiveness of the treatment.

Currently, there are no listed contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. Always consult with your healthcare provider if you have any questions or concerns about its use.

Side Effects

If you experience any discomfort while using this medication, it's important to stop using it and consult your doctor. This warning is in place to ensure your safety and well-being. Always listen to your body and seek medical advice if something doesn’t feel right.

Warnings and Precautions

If you start to feel uncomfortable while using this medication, it's important to stop taking it and consult your doctor. Your health and safety are the top priority, and your doctor can help determine the best course of action for you.

Always be aware of how you feel while using this medication, and don’t hesitate to reach out for help if something doesn’t seem right. Your well-being is essential, and getting professional advice can ensure you stay safe.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get checked by a healthcare professional if you have any concerns about your health. Remember, timely intervention can make a significant difference.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there is no specific information available about the use of this product during pregnancy. The insert does not indicate whether the product is safe or poses any risks to your developing baby. Additionally, there are no recommendations for dosage changes or special precautions for pregnant individuals.

Given the lack of information, it's always best to consult with your healthcare provider before using any medication during pregnancy to ensure the safety of both you and your baby.

Lactation Use

When it comes to breastfeeding, it's important to note that there is no specific information available about the effects of this medication on nursing mothers or lactation (the process of producing milk). This means that the potential impact on your milk production or your baby's health is not clearly defined.

If you are breastfeeding or planning to breastfeed, it's a good idea to discuss any medications you are taking with your healthcare provider to ensure the safety and well-being of both you and your baby.

Pediatric Use

It's important to keep this medication out of reach of children to prevent accidental ingestion. Make sure to store it safely where kids cannot access it. Additionally, remind your child not to swallow the medication, as it is not intended for that use. Always supervise your child when they are taking any medication to ensure their safety.

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 always a good idea to discuss any medications with a healthcare provider. They can help ensure that the treatment is safe and appropriate, considering any unique health needs or conditions that may be present.

Remember, even if there are no specific dosage adjustments or safety concerns mentioned, your healthcare provider can offer personalized advice based on individual health status and any other medications being taken. Always prioritize open communication with your healthcare team to ensure the best outcomes.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations for the medication do not include special monitoring or safety considerations tailored for patients with renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific health needs. They can provide guidance based on your kidney function and overall health.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. Currently, there are no specific drug interactions or laboratory test interactions noted for this medication. However, every individual’s health situation is unique, and your provider can help ensure that your treatment plan is safe and effective for you. Always feel free to ask questions and share all the medications and supplements you are using to avoid any potential issues.

Storage and Handling

To ensure the best performance and safety of your product, store it in a cool, dry place. It's important to keep it away from direct sunlight, as exposure can affect its quality.

When handling the product, always do so with care to maintain its integrity. Following these simple storage and handling guidelines will help you use the product safely and effectively.

Additional Information

You should use this medication topically by gargling 10 mL at a time for 30 seconds, then spit it out. There’s no need to rinse with water afterward. Remember not to swallow the medication, and keep it out of reach of children. If you start to feel uncomfortable while using it, stop and consult your doctor.

FAQ

How should I use this drug?

You should use one (10ml) at a time, gargle for 30 seconds, and then spit it out. There is no need to gargle with water after use.

Are there any contraindications for this drug?

No contraindications are listed for this drug.

What should I do if I feel uncomfortable while using this drug?

You should stop use and ask a doctor if you feel uncomfortable.

Is this drug safe to use during pregnancy?

The insert does not provide specific information regarding use during pregnancy, and no teratogenic effects are mentioned.

Can I swallow this drug?

No, you should not swallow this drug.

How should I store this drug?

Keep it in a cool and dry place, avoiding direct sunlight.

Is there any information about drug interactions?

No drug interactions information is provided.

What precautions should I take regarding children?

Keep this drug out of reach of children.

Packaging Info

Below are the non-prescription pack sizes of Amino Acid Fragrancemouthwash Dawn (oral rinses). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Amino Acid Fragrancemouthwash Dawn.
Details

Drug Information (PDF)

This file contains official product information for Amino Acid Fragrancemouthwash Dawn, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

The drug is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet, which is debossed with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. The formulation includes inactive ingredients such as lactose monohydrate, microcrystalline cellulose, magnesium stearate, and sodium starch glycolate. The tablets are supplied in bottles containing 100 units.

Uses and Indications

This drug is indicated for oral use as a gargle. The recommended dosage is one 10 ml application, which should be gargled for 30 seconds before being expectorated. There is no requirement to rinse with water following the use of this product.

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

Dosage and Administration

Healthcare professionals are advised to store the medication in a cool and dry place, ensuring that it is protected from direct sunlight. Proper storage conditions are essential to maintain the integrity and efficacy of the product.

Contraindications

There are no contraindications listed for this product. However, it is important to note that the product should not be swallowed.

Warnings and Precautions

Healthcare professionals should advise patients to discontinue use and seek medical attention if they experience any discomfort. It is essential to monitor patients for signs of adverse reactions and ensure timely intervention when necessary. Regular follow-up and assessment of the patient's condition are recommended to ensure safety and efficacy during treatment.

Side Effects

Patients are advised to discontinue use and consult a healthcare professional if they experience any discomfort. This warning underscores the importance of monitoring for adverse reactions during treatment. While specific adverse reactions have not been detailed, the recommendation to seek medical advice highlights the potential for individual variability in response to the treatment. It is essential for patients to remain vigilant and communicate any concerns with their healthcare provider.

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 Amino Acid Fragrancemouthwash Dawn (oral rinses). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Amino Acid Fragrancemouthwash Dawn.
Details

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children to prevent accidental ingestion. It is important to instruct children not to swallow the medication.

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 should be aware that there is no specific information regarding the use of this product during pregnancy. The prescribing information does not indicate whether the product is contraindicated in pregnancy or outline any associated risks to the fetus. Additionally, there are no dosage modifications or special precautions recommended for use during pregnancy. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks.

Lactation

There is no specific information available regarding the use of this drug in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the text. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing to this population. Regular monitoring of renal function may be warranted in patients with reduced kidney function to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, is crucial for effective management and follow-up care.

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 use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is important to emphasize that the medication should not be swallowed, and patients should be instructed on the proper method of administration to ensure safety and efficacy.

Storage and Handling

The product is supplied in a configuration that ensures optimal preservation of its integrity. It is essential to store the product in a cool and dry environment, away from direct sunlight, to maintain its efficacy and safety. Proper handling and storage conditions are crucial for the product's stability and should be strictly adhered to by healthcare professionals.

Additional Clinical Information

The recommended route of administration for the product is topical. Patients should gargle one 10 mL dose for 30 seconds and then spit it out, with no need to gargle with water afterward. Clinicians should advise patients not to swallow the product and to keep it out of reach of children. Additionally, patients are instructed to stop use and consult a doctor if they experience any discomfort.

Drug Information (PDF)

This file contains official product information for Amino Acid Fragrancemouthwash Dawn, 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 Amino Acid Fragrancemouthwash Dawn, 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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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.