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Quality Choice 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 2024
Label revision date
August 23, 2024
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 2024
Label revision date
August 23, 2024
Manufacturer
Chain Drug Marketing Association Inc.
Registration number
M001
NDC root
83324-133
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

Quality Choice Infants' Non-Staining Gas Relief Drops are a gentle and safe option designed to provide fast relief from gas symptoms in infants. These drops contain simethicone (20 mg), which helps alleviate discomfort caused by gas that may result from swallowing air or certain formulas and foods.

This product is alcohol-free and dye-free, making it suitable for your little one. If your baby is experiencing gas discomfort, these drops can be a helpful solution to ease their symptoms.

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 fill the enclosed dropper to the recommended level and dispense the liquid slowly into your child's mouth, aiming for the inner cheek to make it easier for them to swallow.

You can give the medication after meals and at bedtime, and you may repeat the dosage as needed. If your child prefers, you can mix the medication with 1 ounce of cool water, infant formula, or another suitable liquid to help with the taste. After each use, be sure to clean the dropper and securely close the bottle to keep it safe for your child.

What to Avoid

There are no specific contraindications, controlled substance classifications, or risks of abuse, misuse, or dependence associated with this medication. This means that, based on the available information, you can use this medication without concerns about these particular issues. However, always consult with your healthcare provider for personalized advice and to ensure that this medication is appropriate for your individual health needs.

Side Effects

When using this product, it's important not to exceed 12 doses in a single day. Taking more than the recommended amount can lead to serious health risks. Always follow the dosage guidelines to ensure your safety and well-being. If you have any concerns about side effects or how to use the product, consult with a healthcare professional.

Warnings and Precautions

When using this product, it’s important not to exceed 12 doses in a single day to avoid potential harm. If you think you may have taken too much, seek emergency medical help immediately or contact a Poison Control Center for assistance.

While there are no specific instructions provided for when to stop taking the product, it’s always a good idea to consult your doctor if you have any concerns or experience unusual symptoms. Your health and safety are paramount, so don’t hesitate to reach out for professional guidance.

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 action 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 medication during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions have not been established.

Before taking any medication, including this one, you should consult with your healthcare provider to discuss potential risks and benefits. They can help you make informed decisions that prioritize your health and the health of 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 it comes to giving this medication to children, it's important to follow specific guidelines based on their age and weight. For infants who are under 2 years old and weigh less than 24 pounds, the recommended dose is 0.3 mL. If your child is over 2 years old and weighs more than 24 pounds, the recommended dose increases to 0.6 mL.

Regardless of your child's age or weight, make sure not to exceed a total of 12 doses in one day. Always consult with your healthcare provider if you have any questions or concerns about the appropriate dosage for your child.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about its effects or safety for this age group. 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 assess any potential risks and determine the best approach based on individual health needs. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

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 information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

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 this medication is generally considered safe to use alongside other treatments and tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you.

Always remember that discussing your full list of medications and any lab tests with your healthcare provider is crucial. This way, you can avoid any potential issues and receive the best care 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 should take this medication orally, and you can repeat the dosage as needed after meals and at bedtime. It's important to keep this medication out of reach of children. If you suspect an overdose, seek medical help or contact a Poison Control Center immediately.

FAQ

What is Quality Choice Infants' Non-Staining Gas Relief Drops used for?

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

What is the active ingredient in these gas relief drops?

The active ingredient is simethicone, which helps relieve gas symptoms.

What is the recommended dosage for infants under 2 years?

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

What is the recommended dosage for children over 2 years?

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

How often can I give this medication?

You can repeat all dosages as needed, after meals and at bedtime, but do not exceed 12 doses per day.

Are there any warnings associated with this product?

Yes, do not exceed 12 doses per day, and in case of overdose, seek medical help or contact a Poison Control Center immediately.

Is it safe to use during pregnancy?

There is no specific information regarding the use of this product during pregnancy, so consult a healthcare professional.

Can nursing mothers use this product?

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

How should I administer the drops?

Shake well before using, fill the enclosed dropper to the recommended dosage level, and dispense the liquid slowly into the baby's mouth toward the inner cheek.

How should I store Quality Choice Infants' Non-Staining Gas Relief Drops?

Store the drops at room temperature and keep out of reach of children.

Packaging Info

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

Packaging configurations for Quality Choice Infants Non-Staining Gas Relief.
Details

Drug Information (PDF)

This file contains official product information for Quality Choice 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

Simethicone is presented in a dosage form of non-staining drops, specifically formulated for infants. Each 1 FL OZ (30 mL) bottle contains 20 mg of simethicone, an effective agent for the relief of gas symptoms. The product is designed to provide fast relief from discomfort associated with gas. It is free from artificial flavors, alcohol, and dyes, ensuring a gentle and safe option for infants.

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 or nonteratogenic effects associated with this drug.

Dosage and Administration

The medication should be shaken well before use. For infants under 2 years of age (weighing less than 24 lb), the recommended dosage is 0.3 mL. For children over 2 years of age (weighing more than 24 lb), the recommended dosage is 0.6 mL.

All dosages may be repeated as needed, with administration recommended after meals and at bedtime. To administer, fill the enclosed dropper to the appropriate dosage level and dispense the liquid slowly into the child's mouth, directing it toward the inner cheek. The medication may also be mixed with 1 oz. of cool water, infant formula, or other suitable liquids to facilitate administration.

It is essential to clean the dropper after each use and securely close the bottle to maintain child resistance.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no identified risks of abuse, misuse, or dependence.

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

Side Effects

Patients should be aware that exceeding 12 doses of this product per day may lead to serious adverse reactions. It is crucial to adhere to the recommended dosage to minimize the risk of potential complications.

In clinical trials and postmarketing experiences, various adverse reactions have been reported, although specific data on the frequency and nature of these reactions were not provided. Continuous monitoring and reporting of any unexpected effects are essential for ensuring patient safety.

Healthcare professionals are encouraged to educate patients on the importance of following dosing guidelines and to report any adverse reactions that may occur during treatment.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been noted in the available data. Therefore, routine monitoring or dosage adjustments related to drug or laboratory test interactions are not required.

Packaging & NDC

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

Packaging configurations for Quality Choice Infants Non-Staining Gas Relief.
Details

Pediatric Use

Pediatric patients under 2 years of age and weighing less than 24 pounds are recommended to receive a dose of 0.3 mL. For children over 2 years of age and weighing more than 24 pounds, the recommended dose is 0.6 mL. It is important to note that the total daily dosage should not exceed 12 doses.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients. Therefore, healthcare providers should exercise caution when prescribing this medication to elderly patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, as age-related physiological changes may influence drug metabolism and response. Additionally, consideration should be given to the presence of comorbidities and concurrent medications that are common in this population, which may necessitate dosage adjustments or increased monitoring.

Pregnancy

There is no specific information available regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions that should be taken. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients and weigh the potential risks and benefits. Women of childbearing potential should be counseled on the absence of established safety data during pregnancy.

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. Regular monitoring of renal function may be advisable in these patients 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 monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide the management of the overdose effectively.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for appropriate treatment 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 seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is essential for patients to understand the seriousness of an overdose and the importance of prompt action to ensure their safety.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers assigned 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

Patients should be informed that the medication is administered orally, with the option to repeat dosages as needed after meals and at bedtime. It is crucial to keep the medication out of reach of children. In the event of an overdose, patients or caregivers should seek medical assistance or contact a Poison Control Center immediately. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Quality Choice 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 Quality Choice 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.