Aluminum Hydroxide, Magnesium Hydroxide and Simethicone

Description

EverPharm is a pharmaceutical formulation containing Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone, designed for antacid and antigas purposes. Each 30 mL unit-dose cup contains 1,200 mg of Aluminum Hydroxide, 1,200 mg of Magnesium Hydroxide, and 120 mg of Simethicone. This product is sugar-free and is intended for institutional use only. The packaging consists of 100 unit-dose cups, each containing the specified dosage form. The National Drug Code (NDC) for EverPharm is 84415-017-01.

Uses and Indications

This drug is indicated for the relief of heartburn, sour stomach, acid indigestion, and symptoms associated with gas.

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

Dosage and Administration

Shake well before use.

For the dosage of 1,200-1,200-120 mg/30 mL:

• Adults and children over 12 years of age: The recommended dose is 30 mL (one unit dose) taken between meals and at bedtime, or as directed by a healthcare professional. The maximum allowable dosage is 4 x 30 mL unit doses (120 mL) within a 24-hour period.

• Children under 12 years of age: Consultation with a healthcare professional is advised.

For the dosage of 2,400-2,400-240 mg/30 mL:

• Adults and children over 12 years of age: The recommended dose is 30 mL (one unit dose) taken one to two times daily, or as directed by a healthcare professional. The maximum allowable dosage is 2 x 30 mL unit doses (60 mL) within a 24-hour period.

• Children under 12 years of age: Consultation with a healthcare professional is advised.

Contraindications

Use of this product is contraindicated in the following situations:

• The product should be kept out of reach of children to prevent accidental ingestion or misuse.

• If symptoms persist for more than 2 weeks, discontinue use and consult a healthcare professional for further evaluation.

Warnings and Precautions

Healthcare professionals should be aware of the following warnings and precautions associated with the use of this medication.

Patients should be advised to consult a physician prior to use if they have a history of kidney disease or are on a magnesium-restricted diet. Additionally, it is important to recommend that patients speak with their doctor or pharmacist if they are currently taking any prescription medications, as antacids may interact with certain drugs.

If symptoms persist for more than two weeks, patients should discontinue use and seek medical advice.

In the event of an accidental overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

General precautions include advising pregnant or breastfeeding individuals to consult a healthcare professional before using this medication. Furthermore, it is essential to keep this product out of reach of children to prevent accidental ingestion.

Side Effects

Patients should be aware of several important warnings associated with the use of this product. It is advised that individuals consult a healthcare professional prior to use if they have kidney disease or are on a magnesium-restricted diet. Additionally, if symptoms persist for more than two weeks, patients should discontinue use and seek medical advice.

For pregnant or breastfeeding individuals, it is crucial to consult a healthcare professional before using this product to ensure safety for both the mother and child. Furthermore, this product should be kept out of reach of children. In the event of an accidental overdose, immediate medical assistance should be sought, or contact with a Poison Control Center (1-800-222-1222) is recommended.

Drug Interactions

Antacids may interact with various prescription medications, potentially affecting their absorption and efficacy. It is advisable to separate the administration of antacids and other medications by at least two hours to minimize the risk of interaction. Monitoring for therapeutic effectiveness of the affected drugs is recommended when antacids are used concurrently.

Packaging & NDC

Below are the non-prescription pack sizes of Aluminum Hydroxide, Magnesium Hydroxide and Simethicone (aluminum hydroxide, magnesium hydroxide, and simethicone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a doctor before use. For patients aged 12 years and older, the dosing varies based on the formulation.

For the 1,200-1,200-120 mg/30 mL formulation, the recommended dose is 30 mL (one unit dose) taken between meals and at bedtime, or as directed by a healthcare professional. The maximum allowable dosage is 4 x 30 mL unit doses (120 mL) within a 24-hour period.

For the 2,400-2,400-240 mg/30 mL formulation, the recommended dose is also 30 mL (one unit dose), which may be taken one to two times daily, or as directed by a healthcare professional. The maximum allowable dosage for this formulation is 2 x 30 mL unit doses (60 mL) in a 24-hour period.

Geriatric Use

Elderly patients should consult a healthcare provider prior to use, particularly if they have a history of kidney disease, as this may necessitate dosage adjustments or increased monitoring. Additionally, it is advisable for geriatric patients to seek guidance from a doctor or pharmacist if they are currently taking any prescription medications, due to the potential for interactions with antacids.

For adults and children over 12 years of age, the recommended dosage is 30 mL, which constitutes one unit dose, to be taken between meals and at bedtime, or as directed by a healthcare professional. It is important for elderly patients not to exceed a total of 120 mL (4 x 30 mL unit doses) within a 24-hour period. Alternatively, the dosage may be adjusted to 30 mL, taken one to two times daily, with a maximum limit of 60 mL (2 x 30 mL unit doses) in a 24-hour period.

For children under 12 years of age, it is essential to consult a healthcare provider before administration. This precaution is particularly relevant for geriatric patients, who may have altered pharmacokinetics and increased sensitivity to medications.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is currently no available data regarding the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have kidney disease. It is also advisable for patients to seek guidance from a doctor or pharmacist if they are currently taking any prescription medications, as antacids may interact with certain prescription drugs. Monitoring and appropriate dosing adjustments may be necessary based on the patient's renal function.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 prescribing information.

Overdosage

In the event of an accidental overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. The national Poison Control Center can be reached at 1-800-222-1222.

Healthcare professionals should be aware that timely intervention is crucial in managing overdose situations. Symptoms of overdose may vary depending on the substance involved, and it is essential to monitor the patient closely for any signs of adverse reactions.

Management of an overdose typically involves supportive care and symptomatic treatment. The specific approach may depend on the nature of the overdose and the patient's clinical status. It is recommended that healthcare providers follow established protocols for overdose management, which may include the administration of activated charcoal, intravenous fluids, or other interventions as deemed necessary based on the clinical scenario.

In all cases of suspected overdose, thorough documentation and communication with the medical team are vital to ensure appropriate care and follow-up.

Nonclinical Toxicology

No teratogenic effects were reported in the studies conducted. Additionally, there was no increase in fetal malformations observed, indicating a lack of non-teratogenic effects.

Information regarding nonclinical toxicology, including specific details on animal pharmacology and toxicology, was not provided in the insert.

Postmarketing Experience

No specific postmarketing experience details are available. As such, there are no additional adverse events or rare case reports to summarize at this time.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. In the event of an accidental overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Patients should be informed to discontinue use and consult a doctor if their symptoms persist for more than two weeks. It is also important for healthcare providers to encourage patients to consult with a doctor before using the medication if they have a history of kidney disease or are on a magnesium-restricted diet.

Additionally, patients should be advised to speak with their doctor or pharmacist prior to use if they are currently taking any prescription medications, as antacids may interact with certain drugs.

Storage and Handling

The product is supplied in packaging that adheres to the National Drug Code (NDC) specifications. It should be stored at a temperature range of 20° to 25°C (68° to 77°F), in accordance with USP Controlled Room Temperature guidelines. It is essential to protect the product from freezing to maintain its integrity. Additionally, the product must not be used if the lid is torn or broken, as this may compromise its safety and efficacy.

Additional Clinical Information

Patients aged 12 years and older are advised to take 30 mL, one unit dose, between meals and at bedtime, or as directed by a healthcare professional. The maximum recommended dosage is 120 mL (4 x 30 mL unit doses) within a 24-hour period. For those taking the formulation containing 2,400-2,400-240 mg/30 mL, the recommended dosage is 30 mL, one to two times daily, not to exceed 60 mL (2 x 30 mL unit doses) in a 24-hour period.

Clinicians should counsel patients to consult a doctor before use if they have kidney disease or are on a magnesium-restricted diet. It is also important to check with a healthcare provider or pharmacist if the patient is taking any prescription medications, as antacids may interact with certain drugs. Patients should discontinue use and seek medical advice if symptoms persist for more than two weeks. Pregnant or breastfeeding individuals should consult a healthcare professional prior to use. Additionally, the product should be kept out of reach of children, and in the event of an accidental overdose, medical assistance should be sought immediately or contact a Poison Control Center at 1-800-222-1222.

Drug Information (PDF)

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

View product document (PDF)