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Infants Gas Relief

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This product has been discontinued

Active ingredient
Dimethicone 20 mg/0.3 mL
Other brand names
Dosage form
Liquid
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2013
Label revision date
March 28, 2013
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Dimethicone 20 mg/0.3 mL
Other brand names
Dosage form
Liquid
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 2013
Label revision date
March 28, 2013
Manufacturer
CVS
Registration number
part332
NDC root
59779-701
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

Infants' GAS RELIEF ORIGINAL FORMULA is 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 contains simethicone (an anti-gas medication that helps break up gas bubbles in the stomach), making it effective in easing your baby's gas-related discomfort.

This formula is free from alcohol, saccharin, and artificial flavors, ensuring a gentle option for your little one. With 100 doses in a 1 FL OZ (30 mL) bottle, it provides a convenient solution for parents looking to soothe their infants' gas issues.

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 using the medication, make sure to shake the bottle well. For infants under 2 years old (weighing less than 24 pounds), the recommended dose is 0.3 mL, while for children over 2 years old (weighing more than 24 pounds), the dose is 0.6 mL. 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.

When giving the medication, fill the enclosed dropper to the recommended level and dispense the liquid slowly into your baby's mouth, aiming for the inner cheek. You can repeat the dose as needed after meals and at bedtime, but be sure not to exceed 12 doses in a single day. For the best results, remember to clean the dropper after each use and put the original cap back on the bottle.

What to Avoid

You can feel reassured that there are no specific contraindications, controlled substance classifications, or risks of abuse or misuse associated with this medication. Additionally, there are no concerns regarding dependence (a condition where your body becomes reliant on a substance).

Since there are no explicit "do not take" or "do not use" instructions, it suggests that this medication is generally safe for use as directed. However, always consult with your healthcare provider for personalized advice and to ensure it’s appropriate for your situation.

Side Effects

You may not experience any specific side effects or adverse reactions while using this medication. It's important to monitor how you feel and report any unusual symptoms to your healthcare provider. Always feel free to ask questions or express concerns about your treatment.

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.

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

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Don’t wait for symptoms to worsen; getting prompt assistance can be vital. Always keep emergency contact information handy and be aware of the signs of overdose to ensure your safety and well-being.

Pregnancy Use

When it comes to using this medication during pregnancy, there is no specific information available about its safety, recommended dosage adjustments, or any special precautions you should take. This means that the potential risks and benefits have not been clearly established for pregnant individuals.

If you are pregnant or planning to become pregnant, it’s important to discuss any medications you are considering with your healthcare provider. They can help you understand the best options for your health and the health of your baby.

Lactation Use

When it comes to breastfeeding, there is currently no specific information available regarding the use of this medication for nursing mothers or its effects during lactation (the period of breastfeeding). This means that if you are breastfeeding, it’s important to consult with your healthcare provider to discuss any potential risks or considerations related to your specific situation. Always prioritize your health and the well-being of your baby by seeking professional advice.

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 recommended dose is 0.3 mL. For children over 2 years old and weighing more than 24 pounds, the dose increases to 0.6 mL. You can repeat these doses as needed after meals and at bedtime, but be sure not to exceed 12 doses in a single day.

To administer the medication, fill the enclosed dropper to the recommended level and gently dispense the liquid into your child's mouth, aiming for the inner cheek. If your child prefers, you can mix the dosage with 1 ounce of cool water, infant formula, or another suitable liquid to make it easier for them to take. Always consult with your child's physician if you have any questions or concerns about their medication.

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

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

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 you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can monitor your health effectively and make informed decisions about your care.

Always feel free to ask questions and share any concerns you may have regarding your medications or tests. Your safety and well-being are the top priority, and your healthcare provider is there to help you navigate your treatment plan.

Storage and Handling

To ensure the safety and effectiveness of your product, always check that the printed foil seal under the cap is intact before use; do not use it if the seal is torn 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 safe usage period. Following these guidelines will help you use the product safely and effectively.

Additional Information

You can take this medication orally, and you may repeat doses 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, consult your healthcare provider for guidance.

FAQ

What is Infants' GAS RELIEF ORIGINAL FORMULA used for?

Infants' GAS RELIEF ORIGINAL FORMULA relieves the discomfort of infant gas frequently caused by air swallowing or certain formulas or foods.

What is the active ingredient in Infants' GAS RELIEF ORIGINAL FORMULA?

The active ingredient is SIMETHICONE, which is an anti-gas agent.

How should I administer Infants' GAS RELIEF ORIGINAL FORMULA?

Shake well before using, fill the enclosed dropper to the recommended dosage level, and dispense the liquid slowly into your baby's mouth, toward the inner cheek.

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 recommended dosage for children over 2 years?

For children over 2 years old and weighing over 24 lbs, the recommended dose is 0.6 mL.

How often can I give Infants' GAS RELIEF ORIGINAL FORMULA?

All doses may be repeated as needed, after meals and at bedtime, or as directed by a physician. Do not exceed 12 doses per day.

Are there any side effects associated with Infants' GAS RELIEF ORIGINAL FORMULA?

No specific side effects or adverse reactions are provided in the information.

What should I do in case of an overdose?

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

Is there any information regarding the use of Infants' GAS RELIEF ORIGINAL FORMULA during pregnancy or nursing?

No specific information regarding use during pregnancy or nursing mothers is provided.

How should I store Infants' GAS RELIEF ORIGINAL FORMULA?

Store at room temperature, do not freeze, and do not use if the printed foil seal under the cap is torn or missing.

Packaging Info

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

Packaging configurations for Infants Gas Relief.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Infants' GAS RELIEF ORIGINAL FORMULA contains simethicone as its active ingredient, which is utilized for the relief of gas-related discomfort. The formulation is free from alcohol and does not contain saccharin as a sweetener. Additionally, it is devoid of artificial flavoring agents. The product is presented in a dosage form that provides 100 doses, with a total volume of 1 fluid ounce (30 mL).

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 product well before use. The recommended dosage varies by age and weight. For infants under 2 years of age (weighing less than 24 lb), the dosage is 0.3 mL. For children over 2 years of age (weighing more than 24 lb), the dosage is 0.6 mL.

All doses 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. To administer, fill the enclosed dropper to the recommended dosage level and dispense the liquid slowly into the baby's mouth, directing it toward the inner cheek.

For optimal results, the dosage may be mixed with 1 oz. of cool water, infant formula, or other suitable liquids. After each use, clean the dropper thoroughly and replace the original cap to maintain product integrity.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no identified risks of abuse, misuse, or dependence.

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 should be sought. Healthcare professionals are advised to contact a Poison Control Center without delay. The national Poison Control Center can be reached at 1-800-222-1222 for guidance and support in managing overdose situations.

Side Effects

No specific side effects or adverse reactions were provided in the SPL text. Therefore, there are no documented adverse reactions associated with the use of this product. It is important for healthcare professionals to monitor patients for any unexpected effects and report them as necessary.

Drug Interactions

There are currently no specific drug interactions identified for this medication. Additionally, no interactions with laboratory tests have been documented. As such, routine monitoring or dosage adjustments based on drug interactions are not necessary. It is advisable for healthcare professionals to remain vigilant and consider individual patient factors when prescribing this medication.

Packaging & NDC

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

Packaging configurations for Infants Gas Relief.
Details

Pediatric Use

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

When administering the medication, the enclosed dropper should be filled to the recommended dosage level, and the liquid should be dispensed slowly into the child's mouth, directed toward the inner cheek. Additionally, the dosage may 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 closely monitor this population for any potential adverse effects or changes in drug efficacy, as age-related physiological changes may influence drug metabolism and response. Additionally, consideration should be given to the presence of comorbidities and concurrent medications that are common in geriatric patients, which may necessitate dosage adjustments or increased monitoring.

Pregnancy

There is no specific information available regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of effective contraception during treatment.

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. The effects on breastfed infants have not been established.

Renal Impairment

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

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 without delay. Healthcare professionals should advise patients or caregivers to call the Poison Control Center at 1-800-222-1222 for guidance.

Prompt intervention is crucial in managing overdose situations, as symptoms may vary depending on the substance involved. Therefore, a thorough assessment and appropriate management strategies should be implemented based on the clinical presentation and the specific agent involved.

Healthcare providers are encouraged to remain vigilant and prepared to initiate supportive care and symptomatic treatment as necessary, following established protocols for overdose management.

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

Storage and Handling

The product is supplied in a configuration that includes a printed foil seal under the cap. It is imperative that the product is not used if this seal is torn or missing, as this may compromise the integrity of the product.

Storage conditions require that the product be kept at room temperature. It is essential to avoid freezing, as this may adversely affect the product's efficacy. 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 doses potentially repeatable as needed, after meals and at bedtime, or as directed by a physician. Clinicians should ensure that patients do not 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 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 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

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.