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Quality Choice

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Active ingredient
Dimethicone, Unspecified 20 mg/0.3 mL
Other brand names
Dosage form
Emulsion
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
August 23, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Dimethicone, Unspecified 20 mg/0.3 mL
Other brand names
Dosage form
Emulsion
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
August 23, 2025
Manufacturer
QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)
Registration number
M002
NDC root
83324-335
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’ Gas Relief Drops are designed to help relieve the discomfort of gas in infants, which can often be caused by swallowing air or certain formulas and foods. The active ingredient, Simethicone (an antigas medication), works by breaking up gas bubbles in the stomach and intestines, making it easier for your baby to pass gas and feel more comfortable.

These drops are dye-free and do not contain saccharin, artificial colors, or flavors, ensuring a gentle option for your little one. With a non-staining formula, each bottle contains 1 fluid ounce (30ml) and provides up to 100 doses, making it a convenient choice for parents seeking relief for their infants.

Uses

If your baby is experiencing discomfort from gas, this medication can help relieve that discomfort. Gas in infants often occurs due to swallowing air or as a reaction to certain formulas or foods. By using this medication, you can help your little one feel more comfortable and at ease.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication, making it a safe option for your baby.

Dosage and Administration

Before you give this medication to your child, make sure to shake the bottle well. To find the right dose, refer to the dosage chart based on your child's weight or age. For infants under 2 years who weigh less than 24 pounds, the dose is 0.3 mL. For children over 2 years who weigh more than 24 pounds, the dose is 0.6 mL. Always use the enclosed syringe for measuring; do not use any other device like a dropper or spoon.

To administer the medication, remove the cap and insert the syringe into the bottle. Pull the syringe plunger until it fills to the prescribed level. If you accidentally go over, simply push the plunger back to the correct level. Slowly dispense the liquid into your child's mouth, aiming for the inner cheek. After giving the dose, clean the syringe with warm, soapy water, but avoid exposing it to high heat. You can repeat the dosage as needed after meals and at bedtime, but do not exceed 12 doses in a single day. If preferred, you can mix the dosage with 1 ounce of cool water, infant formula, or another suitable liquid. Finally, make sure to replace the cap tightly to keep it child-resistant.

What to Avoid

It's important to 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 at 1-800-222-1222. Quick medical attention is crucial, even if you don't see any signs or symptoms of an overdose.

Side Effects

If you take this medication, it's important to be aware of the potential for overdose. If you suspect an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Quick medical attention is crucial, even if you don't notice any signs or symptoms of an overdose. Always prioritize your safety and well-being.

Warnings and Precautions

It's important to 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 at 1-800-222-1222. Quick action is crucial, even if you don't see any signs or symptoms of overdose.

Currently, there are no specific general precautions or laboratory tests required for this medication. However, always stay vigilant and prioritize safety when using any medication.

Overdose

If you suspect an overdose, it’s important to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance. Quick action is crucial, even if you don’t notice any signs or symptoms of an overdose.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you experience any of these symptoms or are concerned about a possible overdose, don’t hesitate to reach out for help. Your safety is the top priority.

Pregnancy Use

While the provided information does not specify any particular safety concerns or dosage modifications for pregnant individuals, it is always important to consult with your healthcare provider before taking any medication during pregnancy. They can provide personalized advice based on your health and circumstances.

Since there are no special precautions mentioned regarding use during pregnancy, maintaining open communication with your doctor about any medications you are considering is essential for ensuring the safety of both you and your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this medication while nursing. Currently, there is also no information available about whether this medication passes into breast milk or if it poses any risk to your infant.

As always, it's a good idea to discuss any medications you are considering with your healthcare provider to ensure they are safe for you and your baby.

Pediatric Use

If your child is experiencing discomfort from gas, which can often happen due to swallowing air or certain foods, this medication can help relieve their symptoms. For infants under 2 years old, the recommended dosage is 0.3 mL if they weigh less than 24 pounds. For children over 2 years old, the dosage increases to 0.6 mL for those who weigh more than 24 pounds. It's best to use your child's weight for dosing, but if that's not possible, you can use their age instead.

Make sure to use only the enclosed syringe for measuring the dose; avoid using other syringes, droppers, or spoons. You can give the medication after meals and at bedtime, or as directed by your child's doctor, but remember not to exceed 12 doses in a single day.

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 considering this medication, it’s important to consult with a healthcare provider. 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

If you have kidney issues, it's important to know that there are no specific guidelines provided for dosage adjustments, special monitoring, or safety considerations related to your condition. This means that the information available does not outline any changes you may need to make regarding your treatment or any additional precautions you should take.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific health needs. They can help you understand how your kidney function may affect your medications and what steps to take for your health.

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 differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication 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, even if there are no known drug interactions or laboratory test interactions associated with them. This ensures that your treatment plan is safe and effective for your individual health needs.

Always keep your healthcare team informed about all the medications and supplements you use, as well as any lab tests you may undergo. This way, they can provide the best care tailored to you.

Storage and Handling

To ensure the safety and effectiveness of your product, always check that the printed seal under the cap is intact before use; do not use it if the seal is broken or missing. Store the product at room temperature, and avoid freezing it, as extreme temperatures can affect its quality. Additionally, make sure to check the bottom panel for the lot number and expiration date to confirm that the product is still within its safe usage period.

By following these simple guidelines, you can help maintain the integrity of the product and ensure your safety while using it.

Additional Information

If you have any questions or comments about your medication, you can call 1-866-467-2748 for assistance. Unfortunately, there is no additional information available regarding laboratory tests, abuse potential, or details about how to take the medication.

FAQ

What is Quality Choice Infants’ Gas Relief Drops used for?

Quality Choice Infants’ Gas Relief Drops relieve the discomfort of infant gas frequently caused by air swallowing or certain formulas or foods.

What is the active ingredient in Quality Choice Infants’ Gas Relief Drops?

The active ingredient is Simethicone, which is an antigas agent.

How should I administer the drops to my child?

Use only the enclosed syringe to administer the drops. Pull the syringe up to the prescribed level and dispense the liquid into your child’s mouth toward the inner cheek.

What is the recommended dosage for infants under 2 years?

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

Are there any warnings associated with Quality Choice Infants’ Gas Relief Drops?

Yes, keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Is this product safe to use during pregnancy or while nursing?

The product does not provide specific information regarding use during pregnancy or nursing mothers.

What should I do if I notice a broken seal on the product?

Do not use the product if the printed seal under the cap is broken or missing.

How should I store Quality Choice Infants’ Gas Relief Drops?

Store the drops at room temperature and do not freeze.

What should I do if I have questions about the product?

You can call 1-866-467-2748 for questions or comments.

Packaging Info

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

Packaging configurations for Quality Choice.
Details

Drug Information (PDF)

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

View product document (PDF)

Uses and Indications

This drug is indicated for the relief of discomfort associated with infant gas, which may frequently result from air swallowing or specific formulas or foods.

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

Dosage and Administration

Shake the medication well before use. Healthcare professionals should refer to the dosage chart below to determine the appropriate dose, prioritizing weight for dosing whenever possible; if weight is not available, age may be used as a guide.

Dosage Chart:

  • Infants under 2 years: For those weighing under 24 lb, the recommended dose is 0.3 mL.

  • Children over 2 years: For those weighing over 24 lb, the recommended dose is 0.6 mL.

Administration should be performed using only the enclosed syringe. Other syringes, droppers, spoons, or dosing devices are not to be used when administering this medication to children.

To administer the dose, remove the cap and insert the syringe into the bottle. Pull the syringe plunger until it is filled to the prescribed level. If the plunger is pulled past the prescribed level, push it back until the desired level is reached. Slowly dispense the liquid into the child’s mouth, directing it toward the inner cheek.

After administration, the syringe should be cleaned with warm, soapy water, ensuring it is not subjected to high heat. All dosages may be repeated as needed after meals and at bedtime, or as directed by a physician. However, it is important not to exceed 12 doses in a 24-hour period. The dosage may also be mixed with 1 oz. of cool water, infant formula, or other suitable liquids. After use, ensure the cap is replaced tightly to maintain child resistance.

Contraindications

There are no specific contraindications listed for this product. However, it is essential to keep the product out of reach of children to prevent accidental ingestion. In the event of an overdose, immediate medical assistance should be sought by contacting a Poison Control Center at 1-800-222-1222, as prompt medical attention is crucial even if no signs or symptoms are apparent.

Warnings and Precautions

It is imperative to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, immediate medical assistance is essential. Healthcare professionals should advise patients to contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help without delay, even if no signs or symptoms are apparent. Prompt intervention is crucial in such situations to mitigate potential health risks.

Currently, there are no specific general precautions or laboratory tests associated with the use of this medication. However, the emphasis on overdose management remains a critical component of patient safety and care.

Side Effects

In the event of an overdose, patients are advised to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt medical attention is crucial, even if no signs or symptoms are apparent. This warning underscores the importance of vigilance regarding dosage to prevent serious health consequences.

Drug Interactions

No specific drug interactions have been identified for this medication. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

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

Packaging configurations for Quality Choice.
Details

Pediatric Use

Pediatric patients may experience discomfort from gas, often resulting from air swallowing or specific formulas and foods. For infants under 2 years of age, the recommended dosage is 0.3 mL for those weighing less than 24 lbs. For children over 2 years, the dosage increases to 0.6 mL for those weighing more than 24 lbs.

When determining the appropriate dosage, it is preferable to use the child's weight; however, age may be used as an alternative if weight is not available. It is essential to administer the medication using only the enclosed syringe, as other syringes, droppers, spoons, or dosing devices may lead to inaccurate dosing.

Dosages may be repeated as needed after meals and at bedtime, or as directed by a physician, but should not exceed 12 doses in a 24-hour period.

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

The available data regarding the use of this medication during pregnancy is limited. There are no specific safety concerns outlined for pregnant patients, nor are there any dosage modifications recommended for this population. Additionally, no special precautions have been identified for the use of this medication in pregnant individuals. Healthcare professionals should consider the potential benefits and risks when prescribing this medication to women of childbearing potential. As always, it is advisable to monitor for any adverse effects and to counsel patients accordingly.

Lactation

There are no specific warnings or recommendations regarding the use of this medication in lactating mothers. Additionally, there is no information available concerning the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt medical intervention is crucial, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the severity of symptoms may vary depending on the specific substance involved in the overdose. Therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous evaluation and appropriate interventions should be implemented to mitigate potential complications associated with the overdose.

Nonclinical Toxicology

No teratogenic effects were noted in animal studies. Additionally, there was no increase in fetal malformations observed in these studies.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is essential to emphasize the importance of seeking immediate medical assistance in the event of an overdose. Patients should be informed to contact a Poison Control Center at 1-800-222-1222 without delay, as prompt medical attention is critical, even if they do not exhibit any signs or symptoms of overdose.

Storage and Handling

The product is supplied in a tamper-evident container. It should not be used if the printed seal under the cap is broken or missing. For optimal storage, the product must be kept at room temperature and should not be frozen. Healthcare professionals are advised to check the bottom panel for the lot number and expiration date to ensure product integrity and safety.

Additional Clinical Information

No further data are available. Patients are advised to call 1-866-467-2748 for any questions or comments regarding their treatment.

Drug Information (PDF)

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