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Premier Value Infants 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 2015
Label revision date
October 28, 2024
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 2015
Label revision date
October 28, 2024
Manufacturer
Chain Drug Consortium
Registration number
M002
NDC root
68016-670

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Drug Overview

Premier Value Infants' Gas Relief is a medication designed to help relieve the discomfort of gas in infants, which can often be caused by swallowing air or certain formulas and foods. It contains Simethicone (20 mg), an ingredient that works by breaking up gas bubbles in the stomach and intestines, making it easier for your baby to pass gas.

This product is formulated to be non-staining and is free from dyes, saccharin, artificial colors, and flavors, ensuring a gentle option for your little one. Each bottle contains 100 doses, making it convenient for use when needed.

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 dosage is 0.3 mL, while for children over 2 years old (weighing more than 24 pounds), the dosage increases to 0.6 mL. You can give the medication directly by filling the enclosed dropper to the recommended level and slowly dispensing the liquid into your child's mouth, aiming for the inner cheek.

If you prefer, 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. You can repeat the dosage as needed after meals and at bedtime, but be sure not to exceed 12 doses in a single day. After each use, clean the dropper and securely replace the bottle cap to keep the medication safe and effective.

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 for assistance.

Currently, 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

It's important to keep this medication out of reach of children. If an overdose occurs, seek medical help or contact a poison control center immediately. This ensures that any potential risks are managed promptly and effectively.

Warnings and Precautions

It's important to keep this medication out of reach of children. If you suspect an overdose, seek medical help immediately or contact a poison control center for assistance.

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 you need it.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately or contact a poison control center. Signs of an overdose can vary, but they may include unusual symptoms that are more severe than typical side effects.

Always err on the side of caution—if you or someone else is experiencing concerning symptoms after taking medication, don’t hesitate to get help. Quick action can make a significant difference in ensuring safety and health.

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 if you are pregnant or planning to become pregnant, it’s important to consult with your healthcare provider before starting or continuing this medication. They can help you weigh the potential risks and benefits based on your individual situation. Always prioritize open communication with your doctor to ensure the best care for you and your baby.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult with your healthcare professional before using this product. There is a possibility that it may be excreted in breast milk, which means it could potentially affect your baby. Since the effects on nursing infants have not been thoroughly studied, it's best to exercise caution. Your healthcare provider can help you weigh the benefits and risks to ensure the safety of both you and your child.

Pediatric Use

When it comes to using this medication for children, it's important to follow specific 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 dose increases to 0.6 mL.

You can give these doses after meals and at bedtime, or as directed by your child's doctor. Just remember not to exceed 12 doses in a single day to ensure your child's safety. Always consult with a healthcare professional if you have any questions or concerns about your child's medication.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available in the drug insert. This means that healthcare providers may not have detailed guidelines tailored for elderly patients. If you or a loved one is an older adult considering this medication, it’s important to discuss any concerns with your healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.

Always ensure that your healthcare provider is aware of any age-related health considerations, as older adults may experience different effects from medications compared to younger individuals.

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.

It's always best to consult with your healthcare provider about your specific situation, as they can offer personalized advice and ensure that any medications you take are safe and effective for you.

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 (issues with liver function).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help monitor your condition and make any necessary adjustments to your treatment plan.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no known drug interactions or laboratory test interactions associated with them. This ensures that your treatment plan is safe and effective for your individual health needs. Always feel free to ask questions or express any concerns you may have regarding your medications or tests. Your health and safety are the top priority.

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 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.

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

Additional Information

You can take the medication as needed, ideally after meals and at bedtime, or as directed by your doctor. It's important not to exceed 12 doses in a single day. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is Premier Value Infants' Gas Relief used for?

It relieves the discomfort of infant gas frequently caused by air swallowing or certain formulas or foods.

What is the active ingredient in Premier Value Infants' Gas Relief?

The active ingredient is Simethicone, which is present at a dosage of 20 mg per dose.

How should I administer Premier Value Infants' Gas Relief?

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 (under 24 lb), the recommended dosage is 0.3 mL.

What is the recommended dosage for children over 2 years?

For children over 2 years (over 24 lb), the recommended dosage is 0.6 mL.

Are there any warnings associated with this product?

Yes, keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away.

Can nursing mothers use Premier Value Infants' Gas Relief?

Nursing mothers should consult a healthcare professional before using this product, as there is a potential for excretion in breast milk.

Is there any information on drug interactions?

No specific drug interactions are mentioned for Premier Value Infants' Gas Relief.

What should I do if the seal under the cap is torn or missing?

Do not use the product if the printed seal under the cap is torn or missing, as it indicates tampering.

How should I store Premier Value Infants' Gas Relief?

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

Packaging Info

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

Packaging configurations for Premier Value Infants Gas Relief.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Simethicone is presented in a dosage form of 20 mg per dose, specifically formulated for the relief of gas-related discomfort. The product is dye-free and does not contain saccharin, artificial colors, or artificial flavors. Each bottle contains 100 doses, with each dose measuring 0.3 mL, totaling 1 fluid ounce (30 mL) per bottle. The product is enclosed with a syringe for accurate dosing. It is distributed by Pharmacy Value Alliance, LLC, located at 407 East Lancaster Avenue, Wayne, PA 19087.

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

The medication should be shaken well before use. Dosages may be repeated as needed after meals and at bedtime, or as directed by a physician. The maximum allowable dosage is 12 doses per day.

For administration, the enclosed dropper should be filled to the recommended dosage level. The liquid should be dispensed slowly into the baby’s mouth, directed toward the inner cheek. Alternatively, the dosage can be mixed with 1 ounce of cool water, infant formula, or other suitable liquids to facilitate administration.

It is essential to clean the dropper after each use and to replace the bottle with the original cap to maintain product integrity.

Dosage by Age and Weight:

  • For infants under 2 years of age (weighing less than 24 pounds), the recommended dosage is 0.3 mL.

  • For children over 2 years of age (weighing more than 24 pounds), the recommended dosage is 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 a poison control center should be contacted.

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 should be sought, or contact with a poison control center is strongly advised. Prompt action is crucial to mitigate potential adverse effects associated with overdose.

Side Effects

Patients should be advised to keep the medication out of reach of children. In the event of an overdose, it is crucial to seek medical assistance or contact a poison control center immediately.

Drug Interactions

There are no specific drug interactions identified for the product, nor are there any noted interactions with laboratory tests. As such, no dosage adjustments or monitoring recommendations are necessary based on the available data.

Packaging & NDC

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

Packaging configurations for Premier Value Infants Gas Relief.
Details

Pediatric Use

Pediatric patients under 2 years of age, weighing less than 24 lb, should receive a dosage of 0.3 mL. For children over 2 years of age, weighing more than 24 lb, the recommended dosage is 0.6 mL. 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 per day.

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, given the physiological changes associated with aging that may affect drug metabolism and response. Additionally, consideration should be given to the possibility of polypharmacy and the increased likelihood of comorbidities in geriatric patients, which may necessitate dosage adjustments or heightened vigilance in monitoring therapeutic outcomes.

Pregnancy

There is no specific information 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 and should be informed of the absence of established safety data in pregnancy.

Lactation

Lactating mothers should consult a healthcare professional before using this product. There is a potential for excretion in breast milk, and the effects on nursing infants are not well studied; therefore, caution is advised.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no 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. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be aware that the management of an overdose may involve supportive care and symptomatic treatment, depending on the specific circumstances and the substance involved. Monitoring of vital signs and assessment of the patient's clinical status are essential components of effective management.

It is recommended that healthcare providers familiarize themselves with the specific symptoms that may arise from an overdose, as these can vary widely based on the substance and the individual patient. Early recognition and appropriate response can significantly improve patient outcomes.

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 use of the compound in question.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help immediately or contact a poison control center for assistance. It is important for patients to understand the seriousness of an overdose and the need for prompt action.

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 torn 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

All dosages of the medication may be repeated 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. No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Premier Value 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 Premier Value 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.

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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.