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Quality Choice Infants Dye Free Gas Relief

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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)
Marketed in the U.S.
Since 2018
Label revision date
December 4, 2025
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
Marketed in the U.S.
Since 2018
Label revision date
December 4, 2025
Manufacturer
CHAIN DRUG MARKETING ASSOCIATION
Registration number
M002
NDC root
63868-696

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Drug Overview

Quality Choice Infants’ Dye-Free 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 in these drops is Simethicone (20 mg), which 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 free from saccharin, artificial colors, and flavors, ensuring a gentle option for your little one. With a volume of 1 fluid ounce (30 ml), the product provides approximately 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 product, you can help ease your baby's tummy troubles and make them feel more comfortable.

Rest assured, this medication does not have any known harmful effects on developing babies during pregnancy.

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 syringe, dropper, or spoon.

To prepare the dose, remove the cap from the bottle and insert the syringe. Pull the plunger back until the syringe is filled to the correct level. If you accidentally fill it too much, simply push the plunger back to reach the desired amount. Administer the liquid slowly into your child's mouth, aiming for the inner cheek. You can give the dose after meals and at bedtime, or as directed by your doctor, but remember not to exceed 12 doses in a single day. If you prefer, you can mix the dose with 1 ounce of cool water, infant formula, or another suitable liquid. After use, 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 ensure their safety. 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

It's important to be aware of potential side effects when taking medication. In the event of 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 stay informed about how your body reacts to any medication, and don't hesitate to reach out to a healthcare professional if you have concerns. Your safety is the top priority.

Warnings and Precautions

It's important to keep this medication out of reach of children to prevent accidental ingestion. In the event of 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 overdose.

While there are no specific general precautions or laboratory tests mentioned, always be mindful of how you feel while taking any medication. If you have any concerns or experience unusual symptoms, it's best to consult your doctor for guidance.

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 or someone else is experiencing these symptoms, don’t hesitate to get help right away. Remember, acting quickly can make a significant difference in the outcome.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of simethicone has not been fully established. While there are no specific studies proving it is harmful, there are also no well-controlled studies in pregnant women to confirm its safety. Simethicone is not outright banned during pregnancy, but you should exercise caution.

Before using simethicone, it’s best to consult with your healthcare provider. They can help you weigh the potential benefits and risks based on your individual situation. There are no specific dosage adjustments recommended for pregnant women, but your healthcare provider can guide you on the appropriate use.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

When giving this medication to your child, it's important to follow the correct dosage based on their age and weight. For infants under 2 years old who weigh less than 24 pounds, the dose is 0.3 mL. For children over 2 years old who weigh more than 24 pounds, the dose is 0.6 mL.

Make sure to use only the syringe that comes with the medication for dosing; avoid using other syringes, droppers, or spoons. You can give the medication after meals and at bedtime, or as your doctor advises, but remember not to exceed 12 doses in a single day.

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

It appears that there is no specific information regarding renal impairment (kidney problems) in the provided text. This means there are no dosage adjustments, special monitoring, or safety considerations outlined for patients with kidney issues. If you have concerns about how your kidney health may affect your treatment, it's important to discuss this with your healthcare provider, who can offer personalized guidance based on your individual 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 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 or tests you may be taking. Currently, there are no specific drug interactions or laboratory test interactions noted for this medication. However, your healthcare provider can help ensure that your treatment plan is safe and effective, taking into account all the medications and tests you may be using. Always feel free to ask questions and share your complete health history to avoid any potential issues.

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, as this information is important for tracking and safety. Following these guidelines will help you use the product safely and effectively.

Additional Information

You can take this medication orally, and you may repeat the dosage as needed after meals and at bedtime, or as directed by your doctor. However, be sure not to exceed 12 doses in a single day. If you have any questions about how to take this medication or its effects, consult your healthcare provider for guidance.

FAQ

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

It relieves the discomfort of infant gas frequently caused by air swallowing or certain formulas or foods.

What is the active ingredient in this product?

The drops contain Simethicone Antigas 20 mg.

How should I administer the drops to my child?

Use only the enclosed syringe for dosing. Pull the syringe up to the prescribed level and slowly dispense the liquid into your child's mouth.

What is the recommended dosage for infants under 2 years?

For infants under 24 lbs, the dose is 0.3 mL.

What is the recommended dosage for children over 2 years?

For children over 24 lbs, the dose is 0.6 mL.

Are there any warnings associated with this product?

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?

Simethicone is not contraindicated in pregnancy, but caution is advised as its safety has not been established.

Can I use this product if I am nursing?

There are no specific warnings or recommendations regarding the use of this product in nursing mothers.

What should I do if the seal under the cap is broken?

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

Where can I find more information about this product?

You can visit the website www.qualitychoice.com or contact 248-449-9300 for more information.

Packaging Info

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

Packaging configurations for Quality Choice Infants Dye Free Gas Relief.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the drug.

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

Healthcare professionals should instruct caregivers to shake the medication well before use. Dosing should be determined primarily by the child's weight; however, if weight is not available, age may be used as a secondary guide. The enclosed syringe must be utilized for dosing; other syringes, droppers, spoons, or dosing devices are not recommended.

To administer the medication, caregivers should remove the cap and insert the syringe into the bottle. The syringe should be pulled up until it is filled to the prescribed level. If the prescribed level is exceeded, the caregiver should push the syringe back until the desired level is reached. The liquid should be dispensed slowly into the child’s mouth, directed toward the inner cheek.

Dosages may be repeated as needed after meals and at bedtime, or as directed by a physician. It is important not to exceed 12 doses in a 24-hour period. The dosage can also be mixed with 1 oz. of cool water, infant formula, or other suitable liquids to facilitate administration. After use, the cap should be replaced tightly to maintain child resistance.

Dosage Chart:

  • Infants under 2 years:

    • Weight: under 24 lb

    • Dose: 0.3 mL

  • Children over 2 years:

    • Weight: over 24 lb

    • Dose: 0.6 mL

Contraindications

Use of this product is contraindicated in the following situations:

  • The product should be kept out of reach of children to prevent accidental ingestion.

  • In the event of an overdose, immediate medical assistance is required. Contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is critical, even in the absence of noticeable signs or symptoms.

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.

No specific general precautions or laboratory tests have been identified for this medication. However, the emphasis on the importance of quick medical attention in the case of an overdose remains a critical aspect of patient safety.

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

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Packaging configurations for Quality Choice Infants Dye Free Gas Relief.
Details

Pediatric Use

Pediatric patients under 2 years old, weighing less than 24 lbs, should receive a dose of 0.3 mL. For children over 2 years old, weighing more than 24 lbs, the recommended dose is 0.6 mL.

It is essential to use only the enclosed syringe for dosing; other syringes, droppers, spoons, or dosing devices should not be utilized. Dosages may be repeated as needed, after meals and at bedtime, or as directed by a physician. The total daily dosage must not exceed 12 doses.

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 efficacy, given the lack of targeted data for this population.

Pregnancy

The safety of simethicone during pregnancy has not been established. There are no adequate and well-controlled studies in pregnant women to assess potential risks to the fetus. While simethicone is not contraindicated in pregnancy, caution is advised when considering its use. Healthcare providers should be consulted before using simethicone, especially for pregnant patients or those planning to become pregnant. No specific dosage modifications for pregnant women are provided.

Lactation

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

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 available information 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, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be warranted based on clinical judgment.

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 lack of immediate symptoms does not preclude the potential for serious adverse effects. Therefore, vigilance and timely action are essential in managing overdose situations effectively.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

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 or seek medical help right away, as prompt 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. Healthcare professionals are advised not to use the product if the printed seal under the cap is broken or missing. It should be stored at room temperature, ensuring that it is not exposed to freezing conditions. For reference, the lot number and expiration date can be found on the bottom panel of the container.

Additional Clinical Information

The medication is administered orally, with all dosages potentially repeatable as needed, after meals and at bedtime, or as directed by a physician. Clinicians should ensure that patients do not exceed a total of 12 doses per day.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Quality Choice Infants Dye Free 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 Dye Free 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

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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.