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Cardinal Health Infants Gas Relief

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Active ingredient
Dimethicone, Unspecified 20 mg/0.3 mL
Other brand names
Dosage form
Suspension/ Drops
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2020
Label revision date
October 14, 2025
Active ingredient
Dimethicone, Unspecified 20 mg/0.3 mL
Other brand names
Dosage form
Suspension/ Drops
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2020
Label revision date
October 14, 2025
Manufacturer
CARDINAL HEALTH
Registration number
M002
NDC root
70000-0051

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Drug Overview

Infants’ Gas Relief Drops contain simethicone, a medication that helps relieve the discomfort caused by gas in infants. This discomfort can often result from swallowing air or from certain formulas or foods. The drops are dye-free and have a non-staining formula, making them a gentle option for your baby.

These drops are designed to provide relief for your little one, and they are comparable to the active ingredient found in Infants’ Mylicon® Drops. With no alcohol, saccharin, artificial colors, or flavors, you can feel confident using this product 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.

Use only the enclosed syringe to measure the dose—do not use any other syringes, droppers, or spoons. 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, then gently dispense the liquid 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 your child prefers, 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

You can feel reassured that there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. This means that, based on the available information, there are no particular situations or conditions under which you should avoid using it. Always consult with your healthcare provider for personalized advice and to ensure that this medication is appropriate for your individual health needs.

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 prioritize your health and safety by being informed and prepared.

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 see any signs or symptoms of overdose.

Currently, there are no specific general precautions or laboratory tests mentioned for this medication. However, always stay informed and consult your healthcare provider if you have any concerns or questions about your treatment.

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 medical attention 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

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 about your health and the health of your baby. Always prioritize open communication with your doctor regarding any medications or treatments during this important time.

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 (or those weighing less than 24 pounds), the recommended dose is 0.3 mL. For children over 2 years old (or those weighing more than 24 pounds), the dose increases to 0.6 mL. You can repeat the dosage as needed after meals and at bedtime, or as directed by your child's doctor, but be sure not to exceed 12 doses in a single day.

Always use the syringe that comes with the medication for dosing; avoid using other syringes, droppers, spoons, or any other devices to ensure accuracy. This helps keep your child safe and ensures they receive the correct amount of medicine.

Geriatric Use

While there is no specific information about how this medication is used in older adults, it’s important to remember that medications can affect seniors differently than younger individuals. If you are caring for an older adult, be aware that their bodies may process medications more slowly, which can lead to a higher risk of side effects or complications.

Always consult with a healthcare provider before starting any new medication for older adults. They can provide guidance on appropriate dosages and monitor for any potential issues, ensuring the safety and well-being of your loved one.

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 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. Currently, there are no specific drug interactions or laboratory test interactions noted for this medication. However, every individual’s health situation is unique, and your provider can help ensure that your treatment plan is safe and effective for you. Always feel free to ask questions and share all the medications and supplements you are using 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 to confirm that the product is still valid for use.

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

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 Infants’ Gas Relief Drops used for?

Infants’ Gas Relief Drops are used to relieve the discomfort of infant gas, which is often caused by air swallowing or certain formulas or foods.

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

The active ingredient is simethicone, which is also found in Infants’ Mylicon® Drops.

How should I administer Infants’ Gas Relief Drops?

Use the enclosed syringe to measure the dose, and dispense the liquid into your child’s mouth towards the inner cheek. Do not use other syringes or dosing devices.

What is the recommended dosage for infants under 2 years?

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

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

Do not exceed 12 doses per day.

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

Yes, keep out of reach of children and in case of overdose, seek medical help or contact a Poison Control Center immediately.

Can I use Infants’ Gas Relief Drops during pregnancy?

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

Is it safe to use Infants’ Gas Relief Drops while nursing?

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

How should I store Infants’ Gas Relief Drops?

Store at room temperature and do not freeze. Ensure the printed seal under the cap is intact before use.

Packaging Info

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

Packaging configurations for Cardinal Health Infants Gas Relief.
Details

Drug Information (PDF)

This file contains official product information for Cardinal Health Infants 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

Shake the medication well before use. Healthcare professionals should refer to the dosage chart to determine the appropriate dose based on the patient's weight; if weight is not available, age may be used as a guide.

The enclosed syringe must be utilized for dosing; other syringes, droppers, spoons, or dosing devices are not recommended. To administer the medication, remove the cap and insert the syringe into the bottle. Pull the syringe plunger up until it is filled to the prescribed level, or push the plunger back until the desired level is reached. Slowly dispense the liquid into the patient's mouth, directing it 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, 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 contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence. Additionally, there are no specific instructions indicating that the product should not be taken or used under any circumstances.

Warnings and Precautions

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

In the event of an overdose, immediate medical assistance is crucial. Healthcare professionals should instruct patients or caregivers to contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help without delay. Quick intervention is essential, even if no signs or symptoms of overdose are apparent.

Currently, there are no additional general precautions or laboratory tests specified for the safe use of this medication. However, healthcare providers should remain vigilant and monitor patients for any adverse effects or unusual reactions during treatment.

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 necessary at this time.

Packaging & NDC

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

Packaging configurations for Cardinal Health Infants Gas Relief.
Details

Pediatric Use

Pediatric patients under 2 years of age (weighing less than 24 lbs) should receive a dose of 0.3 mL, while children over 2 years of age (weighing more than 24 lbs) should receive a dose of 0.6 mL. Dosing may be repeated as needed, after meals and at bedtime, or as directed by a physician. It is important not to exceed 12 doses per day. For accurate dosing, only the enclosed syringe should be used; other syringes, droppers, spoons, or dosing devices are not recommended.

Geriatric Use

Elderly patients may not have been specifically studied in clinical trials for this medication, as the prescribing information does not provide any details regarding geriatric use. Consequently, there are no established dosage adjustments or safety considerations specifically for this population.

Healthcare providers should exercise caution when prescribing this medication to geriatric patients, given the lack of data on its effects in this age group. It is advisable to monitor elderly patients closely for any adverse reactions or changes in efficacy, particularly since age-related physiological changes may influence drug metabolism and response.

Pregnancy

The available prescribing information does not provide specific data regarding the use of this product during pregnancy. Consequently, the safety concerns, dosage modifications, or special precautions for pregnant patients remain undefined. Healthcare professionals should exercise caution when considering this product for women of childbearing potential and weigh the potential risks against the benefits. It is advisable to discuss any concerns with patients and consider alternative therapies if necessary.

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

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 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 early recognition and management of overdose can significantly impact patient outcomes.

It is essential to monitor the patient closely for any potential symptoms that may arise following an overdose. The specific manifestations can vary depending on the substance involved and the amount ingested. Therefore, a thorough assessment and appropriate supportive care should be initiated as soon as possible.

In summary, the key steps in managing an overdose include rapid medical evaluation, contacting poison control, and vigilant monitoring for symptoms, ensuring that the patient receives the necessary care without delay.

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 compound in these areas.

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 medical attention is critical, even if they do not observe 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. Storage conditions require the product to be kept at room temperature, and it must not be frozen. For traceability, 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 able to be repeated as needed, either after meals or at bedtime, unless otherwise 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 Cardinal Health Infants 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 Cardinal Health Infants 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.