Childrens Mylicon All in One Tummy Relief for Kids

Description

Children’s MYLICON® is an antacid and antigas formulation designed for multi-symptom relief of gastrointestinal discomfort in children aged 2 to 11. This product addresses issues such as bloating, gas, and discomfort associated with acid indigestion and overeating. It is presented in a 4 FL OZ (120 mL) dosage form with a bubble gum flavor. The formulation is gluten-free and does not contain saccharin or botanicals. It is manufactured for Infirst Healthcare Inc., located in Westport, CT 06880.

Uses and Indications

This drug is indicated for the relief of symptoms associated with acid indigestion, heartburn, sour stomach, and upset stomach. It is also effective in alleviating pressure and bloating commonly referred to as gas, as well as discomfort resulting from overindulgence in food and drink.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Shake the product well before use. The dosing should be measured using the dosing cup provided. Healthcare professionals should instruct patients to follow the dosage guidelines based on age and weight, or as directed by a physician. Dosing may be repeated as needed, but it is important to note that the maximum dosage should not be used for more than two weeks unless advised and supervised by a healthcare provider. After each use, the dosing cup should be cleaned thoroughly.

For patients under 2 years of age, weighing less than 24 lbs, it is recommended to consult a doctor for appropriate dosing.

For children aged 2 to 5 years, weighing between 24 and 47 lbs, the recommended dosage is 5 mL, with a maximum limit of 15 mL within a 24-hour period.

For children aged 6 to 11 years, weighing between 48 and 95 lbs, the recommended dosage is 10 mL, with a maximum limit of 30 mL within a 24-hour period.

Contraindications

There are no specified contraindications for the use of this product. No conditions or situations have been identified that would warrant avoidance of use.

Warnings and Precautions

It is imperative to consult a healthcare professional, such as a doctor or pharmacist, prior to administration if the patient is currently taking any prescription medications. This is particularly crucial as antacids may interact with certain prescription drugs, potentially leading to adverse effects.

General precautions should be observed to ensure safety. It is essential to keep this medication out of the reach of children to prevent accidental ingestion.

In the event of an overdose, immediate medical assistance is required. Healthcare providers should instruct patients or caregivers to contact a poison control center or seek emergency medical help without delay. The national poison control hotline can be reached at 1-800-222-1222 for guidance and support.

Side Effects

In the event of an overdose, patients should seek medical assistance immediately or contact a poison control center at 1-800-222-1222. This warning is critical for ensuring prompt and appropriate care in such situations.

Drug Interactions

Patients should consult a healthcare professional prior to using this medication if they are currently taking any prescription drugs, particularly in pediatric populations.

Antacids have the potential to interact with various prescription medications. The mechanism of interaction may involve alterations in gastric pH, which can affect the absorption and efficacy of certain drugs. Therefore, it is advisable to monitor for any changes in therapeutic effects when antacids are used concurrently with prescription medications.

Healthcare providers may consider dosage adjustments or alternative therapies based on the specific interactions identified and the clinical context of the patient.

Packaging & NDC

Below are the non-prescription pack sizes of Childrens Mylicon All in One Tummy Relief for Kids (antacid and antigas). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Children aged 2 to 11 years are indicated for the use of Children’s Mylicon All-in-One Tummy Relief. For children under 2 years of age (weighing less than 24 lbs), consultation with a doctor is required prior to use.

For children aged 2 to 5 years (weighing between 24-47 lbs), the recommended dosage is 5 mL, with a maximum limit of 15 mL within a 24-hour period. In children aged 6 to 11 years (weighing between 48-95 lbs), the recommended dosage is 10 mL, not to exceed 30 mL in 24 hours.

It is advised to consult a doctor or pharmacist before use if the child is currently taking any prescription medications, as antacids may interact with certain drugs. In the event of an overdose, immediate medical assistance should be sought, or contact a poison control center at 1-800-222-1222.

Geriatric Use

There is no specific information regarding the use of Children’s Mylicon All-in-One Tummy Relief for Kids in geriatric patients. As such, healthcare providers should exercise caution when considering this product for elderly patients. Due to the lack of clinical data, it is advisable to monitor this population closely for any adverse effects or unexpected responses to the medication. Additionally, dosage adjustments may be necessary based on individual patient assessments, particularly in those with comorbidities or polypharmacy.

Pregnancy

The insert does not provide specific information regarding the use of Children’s Mylicon All-in-One Tummy Relief for Kids during pregnancy. There are no stated safety concerns or contraindications related to pregnancy in the provided text. Additionally, no dosage modifications for pregnant individuals are mentioned, and the insert does not include any special precautions regarding the use of this product during pregnancy. As such, healthcare professionals should consider the absence of data when advising pregnant patients on the use of this product.

Lactation

Nursing mothers should consult a doctor 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 when considering the use of this product during lactation.

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 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 are advised to call the National Capital Poison Center at 1-800-222-1222 for guidance.

Prompt intervention is crucial in managing overdose situations, as timely medical support can significantly influence patient outcomes. Symptoms of overdose may vary depending on the substance involved and the individual’s health status. Therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures should include supportive care and symptomatic treatment as necessary. Healthcare providers should remain vigilant for any signs of adverse reactions and be prepared to implement appropriate interventions based on the clinical presentation.

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 these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a poison control center at 1-800-222-1222 in the event of an overdose. It is crucial for patients to understand the importance of prompt action in such situations.

Additionally, healthcare providers should recommend that patients consult with a doctor or pharmacist before using this medication if their child is currently taking any prescription drugs. This is particularly important as antacids may interact with certain prescription medications, and ensuring safety and efficacy is paramount.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a temperature range of 20-25°C (68-77°F) to maintain its efficacy. Freezing is strictly prohibited, as it may compromise the integrity of the product. Proper container requirements must be adhered to, ensuring that the product is kept in a suitable environment to prevent any degradation. Special handling needs should be observed to ensure optimal storage conditions are maintained throughout the product's shelf life.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients or caregivers to consult a doctor or pharmacist prior to use if the patient is currently taking any prescription medications, as antacids may interact with certain drugs. In the event of an overdose, it is crucial to seek medical assistance or contact a poison control center immediately at 1-800-222-1222.

No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Childrens Mylicon All in One Tummy Relief for Kids, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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