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Walgreens 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 2017
Label revision date
December 2, 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 2017
Label revision date
December 2, 2025
Manufacturer
WALGREEN CO.
Registration number
M002
NDC root
0363-0790

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Drug Overview

Simethicone is a medication designed to relieve the discomfort of gas in infants, which can often be caused by swallowing air or certain formulas and foods. Each dose contains 20 mg of simethicone, and the product is dye-free and alcohol-free, making it a gentle option for your little one.

This nonstaining formula is recommended by pharmacists and comes with a dosing syringe for easy administration. With 100 doses in a 1 FL OZ (30 mL) bottle, simethicone provides a reliable solution for helping to ease your infant's gas-related 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 syringe, dropper, or spoon.

To prepare the dose, remove the cap from the bottle and insert the syringe into the opening. Pull the syringe plunger until it fills to the prescribed level. If you accidentally go over the correct amount, simply push the plunger back to reach the desired level. When giving the medicine, slowly dispense it into your child's mouth, aiming for the inner cheek. You can repeat the dosage as needed after meals and at bedtime, but do not 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 prevent accidental ingestion. If you suspect an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222 for assistance.

There are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this medication. However, always use it responsibly and as directed.

Side Effects

If you take this medication, it's important to be aware of the potential for overdose. 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 prioritize your health and safety by being vigilant about your medication use.

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 medical attention is crucial, even if you don't notice any signs or symptoms of an overdose.

Always be cautious and monitor your health while using this medication. If you experience any unusual symptoms or have concerns, stop using the medication and call your doctor for guidance. Your safety is the top priority, so don’t hesitate to reach out for help when needed.

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

The safety of simethicone during pregnancy has not been established, meaning that it’s unclear whether it is completely safe for you and your developing baby. However, there are no specific contraindications (reasons not to use it) listed for pregnant individuals, and no information is provided about potential risks to the fetus.

If you are pregnant, you do not need to adjust the dosage of simethicone, and there are no special precautions mentioned for its use during this time. As always, it’s best to consult with your healthcare provider before taking any medication while pregnant to ensure it’s appropriate for your situation.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to know that there is no specific information available regarding the effects of this medication on nursing mothers or lactation (the process of producing breast milk). Since the insert does not provide guidance on these topics, it may be wise to consult your healthcare provider for personalized advice. They can help you understand any potential risks and make informed decisions about your health and your baby's well-being.

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 who weigh more than 24 pounds, the dose increases to 0.6 mL. You can repeat these dosages as needed after meals and at bedtime, but be sure not to exceed 12 doses in a single day.

Always use the enclosed syringe for measuring the dose, as other devices like droppers or spoons may not provide accurate measurements. If needed, you can mix the dosage with 1 ounce of cool water, infant formula, or another suitable liquid to make it easier for your child to take.

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 for your individual health needs. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

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 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 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 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 Simethicone used for?

Simethicone is used to relieve the discomfort of infant gas frequently caused by air swallowing or certain formulas or foods.

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 should Simethicone be administered?

Use the enclosed syringe for dosing; do not use other syringes or devices. Slowly dispense the liquid into your child's mouth towards the inner cheek.

Are there any warnings associated with Simethicone?

Yes, in case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Is Simethicone safe to use during pregnancy?

The safety of Simethicone during pregnancy has not been established, and there are no specific contraindications listed.

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 Simethicone be stored?

Store Simethicone at room temperature and do not freeze.

Can Simethicone be mixed with other liquids?

Yes, the dosage can be mixed with 1 oz. of cool water, infant formula, or other suitable liquids.

What is the maximum number of doses I can give in a day?

Do not exceed 12 doses per day.

Packaging Info

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

Packaging configurations for Walgreens Infants Dye Free Gas Relief.
Details

Drug Information (PDF)

This file contains official product information for Walgreens 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, age may be used as an alternative if weight is not available. The enclosed syringe must be utilized for accurate 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 towards 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 ensure child resistance.

Dosage Chart:

  • For infants under 2 years of age weighing under 24 lb, the recommended dose is 0.3 mL.

  • For children over 2 years of age weighing over 24 lb, the recommended dose is 0.6 mL.

Contraindications

Use is contraindicated in children due to the risk of accidental ingestion. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

Warnings and Precautions

It is imperative to keep this medication out of reach of children to prevent accidental ingestion and potential harm.

In the event of an overdose, immediate medical assistance is crucial. Healthcare professionals should advise patients or caregivers to contact a Poison Control Center without delay at 1-800-222-1222. Quick medical attention is essential, even if no signs or symptoms of overdose are apparent, as early intervention can significantly impact outcomes.

Healthcare providers should ensure that patients are aware of these critical warnings and the importance of monitoring for any adverse effects associated with the use of this medication.

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. It is crucial for patients to receive prompt medical attention, even if they do not exhibit any signs or symptoms of overdose. This warning underscores the importance of vigilance in monitoring for potential adverse reactions associated with the use of the medication.

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 necessary at this time.

Packaging & NDC

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

Packaging configurations for Walgreens Infants Dye Free Gas Relief.
Details

Pediatric Use

Pediatric patients under 2 years of age should receive a recommended dose of 0.3 mL if they weigh less than 24 lbs. For children over 2 years, the recommended dose is 0.6 mL for those weighing more than 24 lbs. Doses may be repeated as needed after meals and at bedtime, or as directed by a physician, with a maximum limit of 12 doses per day.

It is essential to use only the enclosed syringe for dosing; other syringes, droppers, spoons, or dosing devices should not be utilized. The dosage can be mixed with 1 oz. of cool water, infant formula, or other suitable liquids to facilitate administration.

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 this population 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 polypharmacy, which are common in geriatric patients and may necessitate dosage adjustments or increased monitoring.

Pregnancy

The safety of simethicone during pregnancy has not been established. There are no specific contraindications for its use in pregnant patients. Currently, there is no information available regarding potential risks to the fetus associated with simethicone. Additionally, no dosage modifications for pregnant individuals are recommended, and no special precautions regarding its use during pregnancy are specified. Healthcare professionals should weigh the potential benefits against the lack of established safety data when considering simethicone for pregnant patients.

Lactation

There is no specific information available regarding the use of this medication in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the lack of data when advising lactating mothers about the use of this medication.

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 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 intervention is essential, as the absence of noticeable signs or symptoms does not preclude the potential for serious health consequences.

Healthcare professionals are advised to remain vigilant and act swiftly, as timely medical attention can significantly influence the outcome of an overdose situation. It is crucial to monitor the patient closely for any emerging symptoms, even if they initially appear asymptomatic.

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 important to inform patients about the risks associated with overdose. In the event of an overdose, patients should seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Additionally, healthcare providers should emphasize the necessity of quick medical attention in cases of overdose, even if patients do not exhibit any signs or symptoms. This proactive approach can be crucial for ensuring patient safety and effective management of potential overdose situations.

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 Walgreens 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 Walgreens 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.