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Act Kids Anticavity Fluoride

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Active ingredient
Sodium Fluoride 1.4 mg/1 g
Other brand names
Dosage form
Paste
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2016
Label revision date
December 1, 2024
Active ingredient
Sodium Fluoride 1.4 mg/1 g
Other brand names
Dosage form
Paste
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2016
Label revision date
December 1, 2024
Manufacturer
Chattem, Inc.
Registration number
M021
NDC root
41167-0922

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Drug Overview

ACT Kids Bubble Gum Blowout is a product designed to help prevent dental cavities in children. It comes in a fun bubble gum flavor, making it appealing for kids while promoting good oral health. By using this product regularly, you can support your child's dental hygiene and help keep their smiles bright and healthy.

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 be an effective way to maintain a healthy smile.

Dosage and Administration

To keep your teeth healthy, it's important to brush thoroughly, ideally after each meal or at least twice a day. This applies to both adults and children aged 2 years and older. If you're helping a child between 2 and 6 years old, make sure to teach them good brushing and rinsing habits to reduce the chance of swallowing toothpaste. Always supervise young children while brushing and use only a pea-sized amount of toothpaste until they can brush on their own.

For children under 2 years of age, you should only use toothpaste if a dentist or doctor has specifically directed you to do so. Following these guidelines will help ensure proper dental care for you and your family.

What to Avoid

It's important to ensure that you use this product safely. Keep it out of reach of children under 6 years old to prevent any accidental ingestion. If a child accidentally swallows more than what is typically used for brushing, seek medical help or contact a Poison Control Center immediately.

By following these guidelines, you can help ensure the safe use of this product.

Side Effects

It's important to keep this product out of reach of children under 6 years old. If a child accidentally swallows more than what is typically used for brushing their teeth, seek medical help or contact a Poison Control Center immediately. This precaution helps ensure their safety and well-being.

Warnings and Precautions

It's important to keep this product out of reach of children under 6 years old. If a child accidentally swallows more than what is typically used for brushing, you should seek medical help immediately or contact a Poison Control Center.

While there are no specific general precautions or laboratory tests mentioned, always use the product as directed. If you have any concerns or experience unusual symptoms, don’t hesitate to reach out to your healthcare provider for guidance.

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

There is currently no specific information available regarding the use of ACT Kids Anticavity Fluoride Bubble Gum Blowout during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been addressed in the drug insert.

If you are pregnant or planning to become pregnant, it is always best to consult with your healthcare provider before using any new products, including dental care items like this one. They can provide personalized advice based on your health and circumstances.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult with your healthcare professional before using this product. There is a possibility that the ingredients may be passed into your breast milk, and the effects on nursing infants have not been thoroughly studied. Therefore, exercising caution is recommended to ensure the safety and well-being of your baby.

Pediatric Use

It's important to keep this product out of reach of children under 6 years old. If your child accidentally swallows more than the amount used for brushing, seek medical help or contact a Poison Control Center immediately. For children aged 2 years and older, encourage them to brush their teeth thoroughly, ideally after each meal or at least twice a day, following the guidance of a dentist or doctor.

For children between 2 and 6 years old, make sure to teach them proper brushing and rinsing techniques to reduce the risk of swallowing the product. Supervise their brushing as needed and use only a pea-sized amount until they can brush independently. For children under 2 years old, do not use this product unless specifically directed by a dentist or doctor.

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 may still recommend monitoring for any potential side effects or interactions with other medications you may be taking. Always prioritize open communication with your healthcare team to ensure the best care.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines, dosage adjustments, or monitoring recommendations provided for your condition in the available information. This means that the standard instructions for the medication do not include special considerations for those with 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 kidney health. They can provide guidance tailored to your specific situation.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication should be used if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help determine the best course of action based on your individual situation.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can monitor your health effectively and make informed decisions about your care.

Always feel free to ask questions and share any other medications or supplements you may be using. This helps to create a comprehensive picture of your health and ensures your safety while receiving treatment.

Storage and Handling

To ensure the best performance of your product, store it at room temperature and keep it away from freezing conditions. It's important to handle the product carefully and to discard it after opening to maintain safety and effectiveness. Following these guidelines will help you use the product safely and effectively.

Additional Information

This medication is applied topically, meaning it is used on the skin or surface of the body. It's important to keep this product 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.

For children under 6, make sure to teach them proper brushing and rinsing habits to reduce the chance of swallowing the product. Always supervise young children while using it and only use a pea-sized amount until they can use it without assistance. Additionally, do not use this product in children under 2 years of age unless specifically directed by a dentist or doctor.

FAQ

What is ACT Kids Bubble Gum Blowout used for?

ACT Kids Bubble Gum Blowout aids in the prevention of dental cavities.

What is the recommended usage for adults and children 2 years and older?

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

How should I supervise children aged 2 to 6 when using this product?

Instruct children in good brushing and rinsing habits to minimize swallowing, supervise as necessary, and use a pea-sized amount until they can use it without supervision.

Can children under 2 years of age use this product?

No, do not use in children under 2 years of age unless directed by a dentist or doctor.

What should I do if more than the recommended amount is swallowed?

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

Are there any contraindications for using ACT Kids Bubble Gum Blowout?

No specific contraindications are listed for this product.

What precautions should I take when using this product?

Keep it out of reach of children under 6 years of age and supervise young children during use.

Is there any information regarding the use of this product during pregnancy?

No specific information regarding safety concerns or precautions during pregnancy is provided.

What should nursing mothers know before using this product?

Nursing mothers should consult a healthcare professional before use, as there is potential for excretion in breast milk.

How should I store ACT Kids Bubble Gum Blowout?

Store at room temperature, protect from freezing, and discard after opening.

Packaging Info

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

Packaging configurations for Act Kids Anticavity Fluoride.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

ACT Kids BUBBLE GUM BLOWOUT is a dental product designed for children. It is packaged in a net weight of 4.6 oz (130 g). The formulation is specifically tailored to appeal to pediatric patients while promoting oral health.

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 are advised to brush their teeth thoroughly, preferably after each meal or at least twice daily, or as directed by a dentist or physician.

For children aged 2 to 6 years, it is essential to instruct them in proper brushing and rinsing techniques to minimize the risk of swallowing. Caregivers should supervise children in this age group as necessary and should use a pea-sized amount of toothpaste until the child is capable of brushing without supervision.

For children under 2 years of age, the product should not be used unless specifically directed by a dentist or physician.

Contraindications

Use is contraindicated in children under 6 years of age due to the potential risk of accidental ingestion. In the event of accidental swallowing of an amount greater than that used for brushing, immediate medical assistance or contact with a Poison Control Center is advised.

Warnings and Precautions

It is imperative to keep this product out of the reach of children under 6 years of age to prevent accidental ingestion. In the event that more than the recommended amount used for brushing is accidentally swallowed, immediate medical assistance should be sought. Healthcare professionals are advised to instruct patients to contact a Poison Control Center or seek emergency medical help without delay.

No specific general precautions or laboratory tests have been identified for this product. However, the emphasis on the importance of monitoring for accidental ingestion remains critical in ensuring patient safety.

Side Effects

Patients should be advised to keep this product out of reach of children under 6 years of age. In the event that more than the recommended amount used for brushing is accidentally swallowed, it is imperative to seek medical assistance or contact a Poison Control Center immediately. This warning highlights the potential risks associated with accidental ingestion in young children, emphasizing the importance of proper usage and supervision.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with 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 Act Kids Anticavity Fluoride (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Act Kids Anticavity Fluoride.
Details

Pediatric Use

Pediatric patients should be advised to keep this product out of reach of children under 6 years of age. In the event that more than the recommended amount for brushing is accidentally swallowed, immediate medical assistance or contact with a Poison Control Center is necessary.

For children aged 2 years and older, it is recommended to brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Children aged 2 to 6 years should be instructed in proper brushing and rinsing techniques to minimize swallowing. Supervision is advised for children under 6 years, and a pea-sized amount of the product should be used until the child is capable of brushing without supervision.

The use of this product is not recommended for children under 2 years of age unless directed by a dentist or doctor.

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

There is no specific information regarding the use of ACT Kids Anticavity Fluoride Bubble Gum Blowout during pregnancy. As such, the safety of this product in pregnant patients has not been established. Healthcare professionals should consider the absence of data when advising women of childbearing potential. Due to the lack of information on potential risks or fetal impacts, caution is advised when recommending this product to pregnant patients. It is important to weigh the benefits against any unknown risks in this population.

Lactation

Lactating mothers should consult a healthcare professional before using this product. There is a potential for excretion in breast milk, and the effects on nursing infants are not well studied; therefore, caution is advised.

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 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 event of an overdosage, immediate medical assistance is crucial. If an individual accidentally swallows more than the amount typically used for brushing, it is imperative to seek medical help or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt intervention can mitigate potential adverse effects associated with overdosage. Monitoring for symptoms related to the specific substance involved is essential, and appropriate management procedures should be initiated based on clinical judgment and established protocols.

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

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of the reach of children under 6 years of age to prevent accidental ingestion. It is important to emphasize the potential risks associated with misuse.

In the event that more than the recommended amount used for brushing is accidentally swallowed, healthcare providers should instruct patients to seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring patient safety and prompt response in case of an emergency.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It should be stored at room temperature, ensuring that it is protected from freezing conditions. Once opened, the product must be discarded to maintain safety and efficacy.

Additional Clinical Information

The product is administered topically. Clinicians should advise patients to keep the product 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. It is important to instruct children under 6 in proper brushing and rinsing techniques to minimize swallowing, and to supervise their use of the product, utilizing only a pea-sized amount until they can use it independently. The product is not recommended for use in children under 2 years of age unless specifically directed by a dentist or doctor.

Drug Information (PDF)

This file contains official product information for Act Kids Anticavity Fluoride, 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 Act Kids Anticavity Fluoride, 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

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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.