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Infants

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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)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2020
Label revision date
October 25, 2025
Drug Information (PDF)
Prescribing information, PDF file
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
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2020
Label revision date
October 25, 2025
Manufacturer
RUGBY LABORATORIES
Registration number
M002
NDC root
0536-1303
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

Rugby Simethicone 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. This product is similar to the active ingredient found in Infants’ Mylicon Drops and is formulated to be dye-free and non-staining, making it gentle for your baby.

Each bottle contains 1 fluid ounce (30 mL) and provides 100 doses, with a syringe included for easy administration. Rugby Simethicone Drops do not contain saccharin, artificial colors, or flavors, ensuring a simple and safe option for easing 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 slowly dispense the liquid into your child's mouth, aiming for the inner cheek. You can give the medication 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 to make it easier for your child to take.

What to Avoid

There are no specific contraindications, controlled substance classifications, or risks of abuse, misuse, or dependence associated with this medication. This means that, based on the available information, there are no known reasons that would prevent you from using it safely. Always consult with your healthcare provider for personalized advice and to ensure that this medication is appropriate for your individual health needs.

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

Always follow your doctor’s instructions regarding the use of this medication. If you experience any unusual symptoms or side effects, stop using the medication and call your doctor for guidance. Your health and safety are the top priority, so don’t hesitate to reach out if you have any concerns.

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

If you are pregnant or planning to become pregnant, it's important to know that there is no specific information available about the use of this medication during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions have not been established.

Before taking this medication, you should discuss it with your healthcare provider to understand any potential risks and to ensure the best care for you and your baby. Always prioritize open communication with your doctor regarding any medications you may be considering during pregnancy.

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. Currently, there is also no information available about whether this product is excreted in breast milk or any potential risks to your infant.

As always, it's a good idea to consult with your healthcare provider if you have any concerns or questions about using this product while breastfeeding. Your health and the health of your baby are important, and your provider can help you make informed decisions.

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 (and 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 your doctor advises, but make 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

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, it’s important to consult with a healthcare provider for personalized advice. 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 or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations for the medication do not include special monitoring or safety considerations tailored for patients with renal impairment (kidney problems).

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific health needs. They can provide guidance based on your kidney function and overall health.

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, and there are no special monitoring requirements or precautions outlined for patients with liver impairment.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe for your liver health. They can provide guidance based on your individual situation and help monitor your liver function as needed.

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 feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

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 usable period. Following these guidelines will help you handle 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 careful not to exceed 12 doses in a single day. If you have any questions about how to take this medication or its effects, be sure to consult your healthcare provider for guidance.

FAQ

What is Rugby Simethicone Drops used for?

Rugby Simethicone Drops relieve the discomfort of infant gas frequently caused by air swallowing or certain formulas or foods.

How should I administer Rugby Simethicone Drops?

Use only the enclosed syringe for dosing. Shake well before use, pull the syringe up to the prescribed level, and slowly dispense the liquid into your child's mouth towards the inner cheek.

What is the recommended dosage for infants and children?

For infants under 2 years (under 24 lbs), the dose is 0.3 mL. For children over 2 years (over 24 lbs), the dose is 0.6 mL.

How often can I give Rugby Simethicone Drops?

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 Rugby Simethicone Drops?

In case of overdose, seek medical help or contact a Poison Control Center immediately. Quick medical attention is critical even if no signs or symptoms are noticed.

Is Rugby Simethicone Drops safe for nursing mothers?

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.

How should I store Rugby Simethicone Drops?

Store at room temperature and do not freeze. Check the bottom panel for the lot number and expiration date.

Packaging Info

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

Packaging configurations for Infants.
Details

Drug Information (PDF)

This file contains official product information for Infants, 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 determine the appropriate dose based on the patient's weight; if weight is not available, age may be used as a guide. Only the enclosed syringe should be utilized for dosing; other syringes, droppers, spoons, or dosing devices are not recommended for administering this medication to children.

To prepare the dose, remove the cap from the bottle and insert the syringe into the opening. Pull the syringe plunger up to fill it to the prescribed level, or push the plunger back until the desired level is reached. Administer the liquid slowly into the child’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 for administration.

Dosage Chart:

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

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

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

It is imperative to keep this medication out of reach of children to prevent accidental ingestion, which could lead to serious health consequences.

In the event of an overdose, immediate medical assistance is crucial. Healthcare professionals should advise patients to seek medical help or contact a Poison Control Center at 1-800-222-1222 without delay. Quick medical attention is essential, even if the individual does not exhibit any signs or symptoms of overdose.

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 the use of 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 Infants (simethicone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Infants.
Details

Pediatric Use

Pediatric patients under 2 years old (weighing less than 24 lbs) should receive a dose of 0.3 mL, while children over 2 years old (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

There is no specific information available 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. 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

There is no specific information available regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions that should be taken. Healthcare professionals are advised to consider the lack of data when prescribing this medication to pregnant patients. The potential risks and benefits should be carefully evaluated, and alternative treatments may be considered in consultation with the patient. Women of childbearing potential should be informed of the absence of established safety data during pregnancy.

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 specific information regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

Hepatic Impairment

Patients with hepatic impairment have no specific dosage adjustments, special monitoring requirements, or precautions indicated in the provided information. Therefore, it is recommended that healthcare professionals exercise clinical judgment when prescribing this medication to individuals with compromised liver function, as the absence of data does not preclude the need for careful consideration of the patient's overall health status and potential risks.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

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 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. 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 potentially repeatable as needed, after meals and at bedtime, or as directed by a physician. Clinicians should advise patients not to exceed 12 doses per day. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Infants, 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 Infants, 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.