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Hismile

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredient
Sodium Fluoride 0.243 g/100 g
Other brand names
Dosage form
Gel
Route
Dental
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2024
Label revision date
September 18, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Sodium Fluoride 0.243 g/100 g
Other brand names
Dosage form
Gel
Route
Dental
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 2024
Label revision date
September 18, 2024
Manufacturer
Accupac LLC
Registration number
M021
NDC root
44038-0322
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

Chupa Chup Cola Flavor Sodium Fluoride Anticavity Toothpaste is a toothpaste designed to help prevent dental cavities. It contains sodium fluoride, which is a common ingredient known for its ability to strengthen tooth enamel and protect against decay.

Using this toothpaste can be a fun way to maintain your oral health, especially with its unique cola flavor that makes brushing your teeth more enjoyable. Regular use can contribute to a healthier smile by reducing the risk of cavities.

Uses

You can use this product to help prevent dental cavities. By incorporating it into your oral care routine, you can support your dental health and reduce the risk of developing cavities, which are small holes in your teeth caused by decay. Regular use can contribute to a healthier smile and better overall oral hygiene.

Dosage and Administration

To keep your teeth healthy, it's important to brush them thoroughly, ideally after each meal or at least twice a day. If you're helping a child under 6, make sure to teach them good brushing and rinsing habits to prevent swallowing toothpaste. You should supervise younger children while they brush until they can do it on their own.

If you have a child who is under 2 years old, it's best to consult a dentist or doctor for guidance on how to care for their teeth properly. Following these steps will help ensure that you and your family maintain good oral hygiene.

What to Avoid

It's important to follow specific guidelines when using this medication to ensure your safety. You should not swallow the medication or use it in the eye area, as these actions can lead to unwanted effects.

While there are no listed contraindications, controlled substance classifications, or concerns about abuse, misuse, or dependence, adhering to these instructions is crucial for your well-being. Always consult with your healthcare provider if you have any questions or concerns about your treatment.

Side Effects

It's important to be aware of some key warnings regarding this product. You should never swallow it or use it in the eye area. Additionally, keep it out of reach of children under 6 years old. If a child accidentally swallows more than what is typically used for brushing, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

It's important to use this product safely. Do not swallow it or apply it near your eyes. Keep it out of reach of children under 6 years old to prevent accidental ingestion.

If you accidentally swallow more than what is needed for brushing, seek medical help immediately or contact a Poison Control Center. Always prioritize your safety and well-being when using this product.

Overdose

If you accidentally swallow more of this product than what is typically used for brushing your teeth, it’s important to seek medical help immediately or contact a Poison Control Center. This is crucial to ensure your safety and receive the appropriate care.

Signs of an overdose may not be obvious, but if you experience any unusual symptoms after swallowing too much, don’t hesitate to reach out for assistance. Remember, it’s always better to be cautious when it comes to your health.

Pregnancy Use

The safety of this product during pregnancy has not been established, which means it’s important to be cautious. Sodium fluoride should not be used while pregnant due to potential risks to your developing baby. If you are pregnant or planning to become pregnant, it’s essential to consult your healthcare provider before using this product. They can provide guidance tailored to your specific situation and help you make informed decisions about your health and the health of your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding nursing mothers in the information provided. Additionally, there are no particular considerations or precautions mentioned for lactation. This suggests that the use of the medication may not pose significant risks to you or your nursing infant. However, it's always a good idea to consult with your healthcare provider about any concerns you may have while breastfeeding.

Pediatric Use

It's important to keep this product out of reach of children under 6 years old. For children in this age group, you should teach them proper brushing and rinsing techniques to help prevent swallowing the product. Always supervise younger children while they are using it until they can do so safely on their own.

If your child is under 2 years old, it's best to consult with a dentist or doctor before use. This ensures that you are making the safest choice for your little one’s health.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult, it’s important to consult with a healthcare provider before starting the medication. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

It appears that there is no specific information regarding renal impairment (kidney problems) in the provided text. Therefore, there are no guidelines, dosage adjustments, or monitoring instructions to share for patients with kidney issues. If you have concerns about how your kidney health may affect your medication or treatment, it's important to discuss these with your healthcare provider for personalized advice.

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 for the medication do not change based on liver impairment. However, it’s always a good idea to discuss your liver health with your healthcare provider, as they can offer personalized advice and monitor your condition appropriately.

Make sure to keep your doctor informed about any liver issues you may have, as they can help ensure that your treatment is safe and effective for you.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that the medication is not known to interfere with other drugs or tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you.

Always discuss any new medications or tests with your healthcare provider to avoid potential issues and to get the best care tailored to your needs.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature, away from direct light. It's important to keep the container tightly closed when not in use to prevent contamination. Once you open the container, please remember to discard it after use to maintain safety and effectiveness. Following these simple steps will help you use the product safely and effectively.

Additional Information

The medication is administered through a dental route, meaning it is used in dental care settings. If you have children, it's important to teach those under 6 years old proper brushing and rinsing techniques to help prevent swallowing the product. You should supervise younger children until they can use it safely on their own. Additionally, if your child is under 2 years old, consult with a dentist or doctor before use.

FAQ

What is Chupa Chup Cola Flavor Sodium Fluoride Anticavity Toothpaste used for?

It aids in the prevention of dental cavities.

How should I use this toothpaste?

Brush your teeth thoroughly, preferably after each meal or at least twice a day, or use as directed by a dentist or doctor.

What precautions should I take for children using this toothpaste?

Instruct children under 6 years of age in good brushing and rinsing habits to minimize swallowing, and supervise them until they can use it without help.

What should I do if a child under 2 years wants to use this toothpaste?

Consult a dentist or doctor before use.

Are there any warnings associated with this toothpaste?

Do not swallow the toothpaste and do not use it in the eye area.

What should I do if more toothpaste than used for brushing is swallowed?

Get medical help or contact a Poison Control Center right away.

Is this toothpaste safe to use during pregnancy?

The safety of this product during pregnancy has not been established, and its use is contraindicated due to potential risks to the fetus.

What should pregnant women do before using this toothpaste?

Consult a healthcare provider before using this product.

How should I store this toothpaste?

Store at room temperature, protect from light, keep the container tightly closed, and discard after opening.

Packaging Info

Below are the non-prescription pack sizes of Hismile (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Hismile.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Chupa Chup Cola Flavor Sodium Fluoride Anticavity Toothpaste is formulated to provide effective cavity protection. This toothpaste contains sodium fluoride as its active ingredient, which is known for its anticavity properties. The product is designed to enhance oral hygiene by helping to prevent dental caries. The formulation is specifically tailored to deliver a cola flavor, appealing to users seeking a unique taste experience in their dental care routine. The effective time for this product is set for July 15, 2024, indicating the period during which the product is expected to maintain its efficacy and quality.

Uses and Indications

This drug is indicated for the prevention of dental cavities. It is intended for use in individuals at risk of developing dental caries.

Dosage and Administration

Adults and children aged 2 years and older should brush their teeth thoroughly, preferably after each meal or at least twice daily, or as directed by a dentist or doctor. It is important to instruct children under 6 years of age in proper brushing and rinsing techniques to minimize the risk of swallowing the product. Caregivers should supervise children as necessary until they are capable of brushing without assistance.

For children under 2 years of age, it is recommended to consult a dentist or doctor prior to use.

Contraindications

The product is contraindicated in the following situations:

Swallowing the product is prohibited due to potential adverse effects associated with ingestion. Additionally, application in the eye area is contraindicated to prevent irritation or injury to the ocular tissues.

Warnings and Precautions

It is imperative to adhere to the following warnings and precautions to ensure the safe use of this product.

Warnings This product is not intended for ingestion; therefore, it must not be swallowed. Additionally, it should not be applied in the eye area to prevent potential irritation or injury.

General Precautions To ensure safety, this product should be kept out of the reach of children under 6 years of age.

Emergency Medical Help Instructions In the event that more than the recommended amount for brushing is accidentally swallowed, it is crucial to seek immediate medical assistance or contact a Poison Control Center without delay.

Healthcare professionals are advised to monitor patients for any adverse reactions and to provide guidance on the appropriate use of this product.

Side Effects

Patients should be advised of the following warnings associated with the use of this product. It is imperative that the product is not swallowed and is not used in the eye area. Additionally, the product should be kept out of reach of children under 6 years of age.

In the event that more than the recommended amount for brushing is accidentally swallowed, patients should seek medical assistance or contact a Poison Control Center immediately. These precautions are essential to ensure the safety and well-being of patients, particularly young children.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

Below are the non-prescription pack sizes of Hismile (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Hismile.
Details

Pediatric Use

Pediatric patients under 6 years of age should be kept out of reach of the product. It is important to instruct these children in proper brushing and rinsing techniques to minimize the risk of swallowing. Supervision is recommended for children until they are capable of using the product independently.

For children under 2 years of age, consultation with a dentist or doctor is advised prior to use.

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 they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in this population.

Pregnancy

The safety of this product during pregnancy has not been established. The use of sodium fluoride is contraindicated in pregnancy due to potential risk to the fetus. Pregnant women should consult a healthcare provider before using this product. It is advised to avoid the use of this product during pregnancy unless directed by a healthcare professional.

Lactation

There are no specific warnings or recommendations regarding nursing mothers. Additionally, there are no specific considerations or precautions mentioned related to lactation. Therefore, healthcare professionals may consider the use of this medication in lactating mothers without specific concerns noted in the available data.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no information available regarding dosage adjustments, special monitoring requirements, or precautions for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, as the lack of data may impact the safety and efficacy of treatment in this population. Regular monitoring of liver function may be warranted based on clinical judgment.

Overdosage

In the event of an overdosage, it is critical to seek immediate medical assistance or contact a Poison Control Center if an amount exceeding that typically used for brushing is accidentally ingested.

Healthcare professionals should be aware that prompt intervention is essential in managing potential overdosage scenarios. Symptoms may vary depending on the specific substance involved, and monitoring for adverse effects is recommended.

Management procedures should include supportive care and symptomatic treatment as necessary. It is advisable to provide the patient with information regarding the amount ingested and the time of ingestion to facilitate appropriate medical response.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to avoid swallowing the product, as it is intended for external use only. Instruct patients to seek immediate medical assistance or contact a Poison Control Center if they accidentally swallow more than the amount used for brushing. Additionally, it is important to inform patients that the product should not be used in the eye area to prevent potential irritation or injury.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, away from direct light exposure to protect its quality. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

The route of administration for the product is dental. Clinicians should instruct parents to teach children under 6 years of age proper brushing and rinsing habits to minimize the risk of swallowing. Additionally, supervision is recommended for children until they are capable of using the product without assistance. For children under 2 years of age, it is advised to consult a dentist or doctor prior to use.

Drug Information (PDF)

This file contains official product information for Hismile, 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 Hismile, 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.