Aluminum Hydroxide, Magnesium Hydroxide and Simethicone

Description

This product is available in two dosage forms: 1,200 mg/30 mL and 2,400 mg/30 mL. The 1,200 mg formulation is identified by the case label NDC 57237-316-31 and the lid label NDC 57237-316-03. The 2,400 mg formulation is designated by the case label NDC 57237-324-31 and the lid label NDC 57237-324-03. Each formulation is presented in a 30 mL container.

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 1,200-1,200-120 mg/30 mL formulation, the recommended dosage for adults and children over 12 years of age 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 children under 12 years of age, consultation with a doctor is advised prior to administration.

For the 2,400-2,400-240 mg/30 mL formulation, adults and children over 12 years of age should take 30 mL (one unit dose) 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. Again, for children under 12 years of age, it is recommended to seek guidance from a doctor before use.

Contraindications

There are no specific contraindications identified for this product. However, it is advised to keep the product out of reach of children. Additionally, if symptoms persist for more than two weeks, discontinue use and consult a healthcare professional.

Warnings and Precautions

It is essential for healthcare professionals to 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 crucial to inform patients to seek guidance from a healthcare provider or pharmacist if they are currently taking any prescription medications, as antacids may interact with certain drugs.

In the event that symptoms persist for more than two weeks, patients must discontinue use and consult a physician for further evaluation.

Emergency medical assistance should be sought immediately in cases of accidental overdose. Patients should be instructed to contact a Poison Control Center at 1-800-222-1222 without delay.

For general precautions, it is recommended that pregnant or breastfeeding individuals consult a healthcare professional before using this medication to ensure safety for both mother and child.

Lastly, it is imperative to keep this medication out of reach of children to prevent accidental ingestion.

Side Effects

Patients should be advised to consult a healthcare professional prior to use if they have kidney disease or are on a magnesium-restricted diet. It is important for patients to discontinue use and seek medical advice if symptoms persist for more than two weeks. Additionally, pregnant or breastfeeding individuals should consult a healthcare professional before using this product.

Patients should also be informed to keep the product out of reach of children. 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.

Drug Interactions

Antacids may interact with various prescription medications, potentially affecting their absorption and efficacy. It is advisable to monitor the timing of antacid administration in relation to other medications to minimize these interactions. Patients should be counseled to separate the dosing of antacids and other drugs by at least two hours when possible to ensure optimal therapeutic outcomes.

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 children and adolescents aged 12 years and older, the dosing regimen differs based on the formulation.

For the 1,200-1,200-120 mg/30 mL formulation, the recommended dose is 30 mL, taken as a single unit dose 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, taken as a single unit dose 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. It is essential for geriatric patients to discuss any concurrent prescription medications with their doctor or pharmacist, as antacids may interact with certain prescription drugs.

For dosing, adults and children over 12 years of age are advised to take 30 mL, which constitutes one unit dose, between meals and at bedtime, or as directed by a healthcare professional. The maximum recommended dosage for this population is 120 mL (four unit doses) within a 24-hour period. For those requiring a dosage of 2,400-240 mg/30 mL, the same initial dosage of 30 mL may be taken one to two times daily, with a maximum of 60 mL (two unit doses) in a 24-hour period.

Children under 12 years of age should seek guidance from a healthcare provider before use. Careful monitoring and adherence to recommended dosages are crucial for ensuring the safety and efficacy of treatment in elderly patients.

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 weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

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 concurrently taking prescription medications, as antacids may interact with certain prescription drugs. Monitoring and appropriate dosing adjustments may be necessary based on individual renal function and concurrent medication use.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

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 symptoms of overdose may vary depending on the specific substance involved. Prompt recognition of these symptoms is crucial for effective management.

Management of an overdose typically involves supportive care and symptomatic treatment. It is essential to monitor the patient closely and provide appropriate interventions based on the clinical presentation.

In all cases of suspected overdose, the involvement of poison control and emergency medical services is recommended to ensure the best possible outcome for the patient.

Nonclinical Toxicology

There is currently no available information regarding teratogenic or non-teratogenic effects associated with the compound. Additionally, no data has been provided concerning nonclinical toxicology, including animal pharmacology and toxicology. As such, a comprehensive assessment of these aspects cannot be made at this time.

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 or contact a Poison Control Center immediately 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 recommend that patients consult a doctor before using the medication if they have kidney disease or are on a magnesium-restricted diet.

Additionally, patients should be encouraged 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 various package configurations, with specific NDC numbers available upon request. 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 requiring a specific dosage of 2,400-2,400-240 mg/30 mL, the recommended intake is 30 mL, one to two times daily, not exceeding 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 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)