Mylanta

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the relief of heartburn, acid indigestion, sour stomach, and upset stomach associated with these symptoms. It also alleviates 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

The medication should be shaken well before use. It is essential to measure the dosage using the dosing cup provided. The medication may be taken as needed, between meals, at bedtime, or as directed by a healthcare professional.

For children aged 6 to 11 years, the recommended dosage is 10 mL, with a maximum limit of 30 mL within a 24-hour period. For adults and children aged 12 years and older, the dosage ranges from 10 to 20 mL, not to exceed 60 mL in a 24-hour period.

It is important to note that the maximum dosage should not be used for more than 2 weeks.

Contraindications

There are no specific contraindications identified for this product. However, it is advised 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 contact a poison control center at 1-800-222-1222.

Additionally, it is recommended to consult a healthcare professional, such as a doctor or pharmacist, prior to use if the patient is currently taking any prescription medications, as antacids may interact with certain drugs.

Warnings and Precautions

Patients should consult a healthcare professional, such as a doctor or pharmacist, prior to using this product if they are currently taking any prescription medications. It is important to note that antacids may interact with certain prescription drugs, potentially affecting their efficacy or safety.

To ensure safety, this product must be kept out of the reach of children. In the event of an overdose, immediate medical assistance is required. Patients or caregivers should contact a poison control center or seek emergency medical help without delay by calling 1-800-222-1222.

There are no specific instructions provided for discontinuation of use; however, patients are encouraged to remain vigilant and consult their healthcare provider if they have any concerns regarding their treatment.

Side Effects

Patients should be aware of the potential for adverse reactions associated with the use of this medication. It is important to consult a healthcare professional, such as a doctor or pharmacist, prior to use, especially if currently taking a prescription drug, as antacids may interact with certain medications.

In the event of an overdose, immediate medical assistance should be sought, or contact a poison control center at 1-800-222-1222. Additionally, this product should be kept out of reach of children to prevent accidental ingestion and potential harm.

Drug Interactions

Antacids, particularly those containing calcium carbonate, may interact with certain prescription medications. This interaction can potentially alter the absorption and efficacy of these drugs. It is advisable for healthcare professionals to monitor patients closely when these antacids are co-administered with other medications, and to consider dosage adjustments as necessary to ensure therapeutic effectiveness.

No additional drug interactions or laboratory test interactions have been reported.

Packaging & NDC

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

Pediatric Use

Pediatric patients should be kept out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or a poison control center contacted at 1-800-222-1222.

For dosing, children aged 6 to 11 years may receive 10 mL, with a maximum limit of 30 mL within a 24-hour period. For adolescents and adults aged 12 years and older, the recommended dosage ranges from 10 to 20 mL, not to exceed 60 mL in a 24-hour period.

Geriatric Use

There is no specific information 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

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. The potential risks and benefits should be carefully evaluated, and alternative treatments may be considered in the absence of established safety profiles. Women of childbearing potential should be counseled on the importance of effective contraception during treatment.

Lactation

There are no specific warnings or recommendations regarding the use of Mylanta in lactating mothers. Additionally, there is no information available concerning the potential for excretion of Mylanta 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 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 be initiated as per established protocols, which may include supportive care and symptomatic treatment. It is essential for healthcare providers to remain vigilant and prepared to address any complications that may arise during the management of an overdose.

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. Further studies may be necessary to elucidate these aspects of nonclinical 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. In the event of an overdose, patients should be instructed to seek medical help immediately or contact a poison control center at 1-800-222-1222.

Additionally, it is important for healthcare providers to remind patients to consult with a doctor or pharmacist before using this medication if they are currently taking any prescription drugs. Patients should be made aware that antacids may interact with certain prescription medications, and this interaction could affect the efficacy or safety of their treatment.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a temperature range of 20-25°C (68-77°F). Freezing the product is strictly prohibited, as it may compromise its integrity and efficacy. Proper storage conditions must be maintained to ensure the product remains effective and safe for use.

Additional Clinical Information

The medication is administered orally. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)