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Publix Infants Dye Free

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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 2019
Label revision date
October 28, 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 2019
Label revision date
October 28, 2025
Manufacturer
PUBLIX SUPER MARKETS, INC
Registration number
M002
NDC root
41415-709

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

Publix Infants’ Gas Relief is a medication designed to help relieve the discomfort of gas in infants, which can often occur due to swallowing air or from certain formulas and foods. It contains simethicone (an anti-gas ingredient) in a dye-free, non-staining liquid form, making it suitable for young children.

This product is alcohol-free and does not contain saccharin, artificial colors, or flavors, ensuring a gentle option for your baby. Each 1-ounce bottle provides up to 100 doses, allowing for easy administration to help soothe your infant's gas discomfort.

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. This product is designed specifically to ease that discomfort, making your little one feel more comfortable.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication, so you can use it with confidence.

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 prepare the dose, remove the cap from the bottle and insert the syringe. Pull the syringe plunger until it fills to the prescribed level. If you accidentally go over, simply push the plunger back to the correct mark. Administer the liquid slowly into your child's mouth, aiming for the inner cheek. You can give doses after meals and at bedtime, or as directed by your doctor, but do not exceed 12 doses in a single day. If preferred, 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 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

It's important to be aware of potential side effects when taking medication. In the event of an overdose, you should 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 to use your medication safely, and don't hesitate to reach out to a healthcare professional if you have any concerns.

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, you should 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 symptoms.

While there are no specific precautions or lab tests mentioned, always stay vigilant about your health. If you experience any unusual symptoms or have concerns, don't hesitate to reach out to your doctor for guidance. Your safety is the top priority.

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 see 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 notice any of these symptoms, don’t hesitate to get help right away. Remember, acting quickly can make a significant difference in your safety and health.

Pregnancy Use

When it comes to using this product during pregnancy, there is no specific information available about its safety, dosage adjustments, or any special precautions you should take. This means that if you are pregnant or planning to become pregnant, it’s important to consult with your healthcare provider before using this product. They can help you understand any potential risks and make informed decisions that are best for you and your baby. Always prioritize open communication with your doctor regarding any medications or treatments during this important time.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to be aware that there is no specific information available regarding the use of this medication during nursing. This means that the effects on breast milk and your baby are not clearly defined.

As a precaution, you may want to consult with your healthcare provider to discuss any potential risks and to ensure that you are making the best choices for both you and your infant. Always prioritize open communication with your doctor about any medications you are considering while breastfeeding.

Pediatric Use

When giving this medication to your child, it's important to follow specific dosing guidelines 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 who weigh more than 24 pounds, the recommended dose is 0.6 mL. If you’re unsure about the correct dose, it's best to use your child's weight; otherwise, you can refer to their age.

Make sure to use only the syringe provided with the medication for dosing—other tools like droppers or spoons can lead to incorrect amounts. You can give doses after meals and at bedtime, or as your doctor advises, but remember not to exceed 12 doses in a single day. Always consult with your healthcare provider if you have any questions or concerns about your child's medication.

Geriatric Use

While there is no specific information about the use of this medication in older adults, it’s important to remember that each person’s health needs can vary. Since the insert does not mention any age-related dosage adjustments, safety concerns, or special precautions for elderly patients, you should always consult with a healthcare provider before starting any new medication. They can help ensure that the treatment is appropriate for your individual health situation and any other medications you may be taking.

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 for patients with 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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your complete list of medications and any recent lab tests to avoid any potential issues. Your health and safety should always come first.

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. For your reference, the lot number and expiration date can be found on the bottom panel of the packaging, so be sure to check these details before use.

Additional Information

You will take this medication orally. There are no additional details available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences. If you have any questions or concerns about your treatment, be sure to discuss them with your healthcare provider.

FAQ

What is Publix Infants’ Gas Relief used for?

Publix Infants’ Gas Relief is used to relieve the discomfort of infant gas frequently caused by air swallowing or certain formulas or foods.

What is the active ingredient in Publix Infants’ Gas Relief?

The active ingredient is SIMETHICONE ANTIGAS 20 MG.

How should I administer Publix Infants’ Gas Relief?

Use the enclosed syringe for dosing; do not use other syringes, droppers, or spoons. Shake well before using 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 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 weighing over 24 lbs, the recommended dose is 0.6 mL.

How often can I give this medication?

All dosages may be repeated as needed, after meals and at bedtime, but do not exceed 12 doses per day.

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 Publix Infants’ Gas Relief safe during pregnancy?

The insert does not provide specific information regarding the use of this product during pregnancy.

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.

How should I store Publix Infants’ Gas Relief?

Store at room temperature and do not freeze.

Packaging Info

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

Packaging configurations for Publix Infants Dye Free.
Details

Drug Information (PDF)

This file contains official product information for Publix Infants Dye Free, 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

Shake the bottle well before use. The appropriate dose should be determined using the dosage chart provided below, prioritizing weight for dosing whenever possible; if weight is not available, age may be used as a guide. Only the enclosed syringe should be utilized for administration; other syringes, droppers, spoons, or dosing devices are not recommended for use with this medication.

To administer the dose, remove the cap and insert the syringe into the bottle. Pull the syringe plunger until the liquid reaches the prescribed level. If the liquid exceeds the desired level, push the plunger back to the correct mark. Administer the liquid slowly into the child’s mouth, directing it toward the inner cheek.

All 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 may also be mixed with 1 oz. of cool water, infant formula, or other suitable liquids to facilitate administration. After use, ensure the cap is 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

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, or 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 instruct patients to seek emergency medical help or contact a Poison Control Center at 1-800-222-1222 without delay. Prompt medical attention is critical, even if the patient does not exhibit any signs or symptoms of overdose.

While no specific instructions for discontinuation or additional precautions are provided, it is advisable for healthcare providers to remain vigilant and monitor patients for any adverse effects or unusual reactions during treatment. Regular communication with patients regarding their health status is encouraged to ensure safe use of the medication.

Side Effects

In the event of an overdose, it is critical for patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Quick medical attention is essential, even if no signs or symptoms are apparent. This warning underscores the importance of vigilance regarding dosage and the potential risks associated with exceeding recommended amounts.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known 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 Publix Infants Dye Free (simethicone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Publix Infants Dye Free.
Details

Pediatric Use

Pediatric patients under 2 years of age should receive a recommended dose of 0.3 mL if they weigh under 24 lbs. For children over 2 years, the recommended dose is 0.6 mL for those weighing over 24 lbs. It is advised to use weight for dosing whenever possible; if weight is not available, age may be used as a guide.

Administration should be performed using the enclosed syringe only; other syringes, droppers, spoons, or dosing devices are not recommended. Dosages may be repeated as needed after meals and at bedtime, or as directed by a physician, with a maximum of 12 doses per day.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, as the prescribing information does not provide any age considerations, dosage adjustments, safety concerns, or special precautions for this population.

Healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, considering the absence of data specific to this demographic. Monitoring for efficacy and safety is advised, as individual responses may vary.

Pregnancy

The safety of this product during pregnancy has not been established, as the prescribing information does not provide specific data regarding its use in pregnant patients. There are no known safety concerns, dosage modifications, or special precautions outlined for women who are pregnant. Healthcare professionals should consider the lack of available information when prescribing this product to women of childbearing potential and weigh the potential risks and benefits. It is advisable to monitor pregnant patients closely if this product is deemed necessary.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or lactation considerations. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. Further research may be necessary to fully understand the implications for breastfed infants.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the text. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing to this population. Regular assessment of renal function may be warranted to ensure safe and effective use of the medication in 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 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 lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, it is essential to monitor the patient closely and provide appropriate care based on clinical judgment and established protocols.

Nonclinical Toxicology

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

Postmarketing Experience

No postmarketing experience details are provided 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, even if they do not exhibit any signs or symptoms of overdose. Quick medical attention is critical in such situations to ensure patient safety.

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. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Publix Infants Dye Free, 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 Publix Infants Dye Free, 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.