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Infants Non Staining Gas Relief

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Active ingredient
Dimethicone 20 mg/0.3 mL
Other brand names
Dosage form
Solution/ Drops
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2025
Label revision date
February 27, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Dimethicone 20 mg/0.3 mL
Other brand names
Dosage form
Solution/ Drops
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 2025
Label revision date
February 27, 2025
Manufacturer
Retail Business Services, LLC.
Registration number
M002
NDC root
72476-520
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

CareOne™ is a medication designed specifically for infants to help relieve the discomfort caused by gas. Its active ingredient, simethicone (20 mg), works by breaking up gas bubbles in the stomach and intestines, making it easier for your baby to pass gas. This can be particularly helpful for infants who experience gas due to swallowing air or from certain formulas or foods.

You can safely use CareOne™ at every feeding, and it features a non-staining formula that is free from artificial flavors, alcohol, saccharine, and dyes. This makes it a gentle option for your little one when they need relief from gas-related discomfort.

Uses

If you're experiencing discomfort from gas, this medication can help relieve those symptoms. Gas can often be caused by swallowing air or by certain foods and formulas you consume. This product is designed to ease that discomfort, allowing you to feel more at ease.

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. You can use it with confidence, knowing it is safe in that regard.

Dosage and Administration

Before you use this medication, make sure to shake the bottle well. For infants under 2 years old (weighing less than 24 pounds), the recommended dosage is 0.3 mL, while for children over 2 years old (weighing more than 24 pounds), the dosage is 0.6 mL. You can repeat these dosages as needed, especially after meals and at bedtime.

To give the medication, fill the enclosed dropper to the recommended level and dispense the liquid slowly into your child's mouth, aiming for the inner cheek. If you prefer, you can mix the medication with 1 ounce of cool water, infant formula, or another suitable liquid to make it easier for your child to take. Remember to clean the dropper after each use and securely close the bottle to keep it safe for your child.

What to Avoid

There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. Additionally, there are no explicit instructions indicating that you should not take or use this medication. Always consult with your healthcare provider for personalized advice and to ensure this medication is appropriate for you.

Side Effects

When using this product, it's important to follow the recommended guidelines and not exceed 12 doses per day. While no specific adverse reactions or side effects have been reported, it's always wise to monitor how you feel and consult a healthcare professional if you have any concerns.

Warnings and Precautions

It's important to use this product safely. Do not take more than 12 doses in a single day, as exceeding this limit can lead to serious health issues.

If you suspect an overdose, seek emergency medical help immediately or contact a Poison Control Center. Your health and safety are paramount, so please be cautious and follow these guidelines closely.

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 or symptoms of an overdose for this medication, general signs may include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or have concerns about a possible overdose, seek medical help right away. It's always better to be safe and get professional advice if you think you or someone else may have taken too much of a medication.

Pregnancy Use

When it comes to using this medication during pregnancy, there are no specific guidelines or safety concerns outlined. This means that there is no information available about how the medication may affect you or your baby while you are pregnant. Additionally, there are no recommended changes to the dosage for pregnant individuals, nor are there any special precautions to consider.

If you are pregnant or planning to become pregnant, it’s always best to discuss any medications with your healthcare provider to ensure the safest choices for you and your baby.

Lactation Use

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

Pediatric Use

When giving this medication to your child, it's important to follow the recommended dosages based on their age and weight. For infants under 2 years old who weigh less than 24 pounds, the recommended dose is 0.3 mL. For children over 2 years old and weighing more than 24 pounds, the dose increases to 0.6 mL. You can safely administer this medication at every feeding as long as you follow the directions, but be sure not to exceed 12 doses in a single day.

Always keep this medication out of reach of children to prevent accidental ingestion. If you suspect an overdose, seek medical help immediately or contact a Poison Control Center for assistance.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the right dosage and monitor for any potential side effects, ensuring that the treatment is safe and effective for you or your loved one.

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 usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

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 may affect you if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

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 all the medications and supplements you are using. This helps to avoid any potential issues and ensures that you receive the best possible treatment tailored to your needs.

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

You can take this medication orally, and you may repeat the dosage as needed after meals and at bedtime. It is safe to use at every feeding. To ensure safety, remember to clean the dropper after each use and securely close the bottle to keep it child-resistant.

FAQ

What is CareOne™ used for?

CareOne™ is used to relieve the symptoms of gas frequently caused by air swallowing or certain formulas or foods.

What is the active ingredient in CareOne™?

The active ingredient in CareOne™ is Simethicone, which is present at a dosage of 20 mg.

Is CareOne™ safe to use for infants?

Yes, CareOne™ is safe to use at every feeding when used as directed.

What is the recommended dosage for infants under 2 years?

For infants under 2 years old and weighing under 24 lbs, the recommended dose is 0.3 mL.

What is the recommended dosage for children over 2 years?

For children over 2 years old and weighing over 24 lbs, the recommended dose is 0.6 mL.

Are there any warnings associated with CareOne™?

Yes, do not exceed 12 doses per day when using CareOne™.

What should I do in case of an overdose?

In case of overdose, get medical help or contact a Poison Control Center right away.

Can nursing mothers use CareOne™?

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

How should CareOne™ be administered?

CareOne™ should be dispensed slowly into the baby's mouth, toward the inner cheek, and may be mixed with 1 oz. of cool water, infant formula, or other suitable liquids.

What should I do to maintain the product's safety?

Clean the dropper after each use and close the bottle to maintain child resistance.

Packaging Info

Below are the non-prescription pack sizes of Infants Non Staining Gas Relief (simethicone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Infants Non Staining Gas Relief.
Details

Drug Information (PDF)

This file contains official product information for Infants Non Staining Gas Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

CareOne™ is a simethicone-based formulation designed for infants' gas relief, containing 20 mg of simethicone per 1 FL OZ (30 mL) of solution. This product is comparable to the active ingredient in Mylicon® Drops Dye-Free Formula. The formulation is non-staining and free from artificial flavors, alcohol, saccharine, and dyes, making it suitable for use at every feeding.

Uses and Indications

This drug is indicated for the relief of symptoms associated with gas, which may frequently result from air swallowing or the consumption of certain formulas or foods.

There are no teratogenic effects associated with this drug, and no nonteratogenic effects have been reported.

Dosage and Administration

Healthcare professionals should instruct caregivers to shake the bottle well before each use. The recommended dosages are as follows:

For infants under 2 years of age (weighing less than 24 lb), the dosage is 0.3 mL. For children over 2 years of age (weighing more than 24 lb), the dosage is 0.6 mL. All dosages may be repeated as needed, after meals and at bedtime.

To administer the medication, caregivers should fill the enclosed dropper to the recommended dosage level. The liquid should be dispensed slowly into the baby's mouth, directed toward the inner cheek. It is permissible to mix the medication with 1 oz. of cool water, infant formula, or other suitable liquids to facilitate administration.

After each use, the dropper should be cleaned thoroughly, and the bottle should be securely closed to maintain child resistance.

Contraindications

There are no contraindications listed for the use of this product. It is important to evaluate each patient's individual circumstances and medical history when considering treatment options.

Warnings and Precautions

When using this product, it is imperative that the daily dosage does not exceed 12 doses. Exceeding this limit may lead to serious health complications.

In the event of an overdose, immediate medical assistance is crucial. Healthcare professionals should advise patients to seek emergency medical help or contact a Poison Control Center without delay.

Patients are also advised to discontinue use of the product and consult their healthcare provider if they experience any concerning symptoms or adverse effects. Regular monitoring and communication with a healthcare professional are essential to ensure safe usage.

Side Effects

Patients should be aware that when using this product, it is crucial not to exceed 12 doses per day. Exceeding this dosage may lead to serious adverse reactions, although specific side effects have not been detailed in the available data.

In clinical practice and postmarketing experiences, no additional adverse reactions or side effects have been reported. However, healthcare providers should monitor patients for any unexpected reactions, particularly in the context of dosage adherence.

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 Infants Non Staining Gas Relief (simethicone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Infants Non Staining Gas Relief.
Details

Pediatric Use

Pediatric patients under 2 years of age and weighing less than 24 lbs are recommended to receive a dose of 0.3 mL. For children over 2 years of age and weighing more than 24 lbs, the recommended dose is 0.6 mL. The product is safe for use at every feeding when administered as directed.

It is important not to exceed 12 doses per day. Caregivers should ensure that the product is kept out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients should be aware that there is no specific information regarding the use of this medication during pregnancy. Currently, there are no known safety concerns associated with its use in this population, and no dosage modifications are recommended for pregnant individuals. Additionally, there are no special precautions outlined for the use of this medication in pregnant patients. Healthcare professionals should consider the absence of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks.

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 a nursing infant are not well studied; therefore, caution is advised.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring of these patients.

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, the following management procedures should be considered:

  1. Assessment: Conduct a thorough assessment of the patient's clinical status, including vital signs and level of consciousness.

  2. Supportive Care: Provide supportive care as needed, which may include airway management, oxygen supplementation, and intravenous fluids.

  3. Consultation: Engage with a poison control center or toxicology specialist for guidance on specific interventions and antidotes, if applicable.

  4. Documentation: Document all findings, interventions, and the patient's response to treatment meticulously.

Healthcare professionals should remain vigilant and prepared to implement appropriate measures in the event of an overdose, even in the absence of specific overdosage data.

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 seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is important for patients to understand the seriousness of an overdose and the necessity of prompt action to ensure their safety.

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; however, standard precautions should be observed to ensure optimal storage conditions.

Additional Clinical Information

The medication is administered orally, with all dosages able to be repeated as needed after meals and at bedtime. Clinicians should counsel patients that it is safe to use at every feeding. Additionally, it is important to clean the dropper after each use and securely close the bottle to ensure child resistance.

No further information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Infants Non Staining Gas Relief, 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 Infants Non Staining Gas Relief, 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.