Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Almacone Double Strength

Last content change checked dailysee data sync status

Active ingredients
  • Dimethicone 40 mg/5 mL
  • Aluminum Hydroxide 400 mg/5 mL
  • Magnesium Hydroxide 400 mg/5 mL
Other brand names
Drug classes
Calculi Dissolution Agent, Osmotic Laxative
Dosage form
Suspension
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2011
Label revision date
November 2, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Dimethicone 40 mg/5 mL
  • Aluminum Hydroxide 400 mg/5 mL
  • Magnesium Hydroxide 400 mg/5 mL
Other brand names
Drug classes
Calculi Dissolution Agent, Osmotic Laxative
Dosage form
Suspension
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2011
Label revision date
November 2, 2023
Manufacturer
RUGBY LABORATORIES
Registration number
M001
NDC root
0536-0015
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

You may find this medication helpful if you experience discomfort from heartburn, sour stomach, acid indigestion, or gas. It is designed to relieve these common digestive issues, providing you with some much-needed comfort. By addressing these symptoms, it can help improve your overall well-being and make daily activities more enjoyable.

Uses

If you're experiencing discomfort from heartburn, a sour stomach, or acid indigestion, this medication can help relieve those symptoms. It also addresses issues related to gas, providing you with some much-needed comfort.

You can feel confident using this medication, as there are no known teratogenic effects (which means it doesn't cause birth defects) associated with it. This makes it a safer option for those who may be concerned about such risks.

Dosage and Administration

Before you use this medication, make sure to shake the bottle well. If you are an adult or a child aged 12 years and older, you can take 2 to 4 teaspoonfuls between meals or at bedtime, or as your doctor advises. However, it’s important not to exceed 12 teaspoonfuls in a 24-hour period, and you should not use the maximum dosage for more than 2 weeks.

If the patient is a child under 12 years old, it’s best to consult a doctor before giving them this medication. Always follow the guidance provided by your healthcare professional to ensure safe and effective use.

What to Avoid

You can feel reassured that there are no specific contraindications, controlled substance classifications, or risks of abuse or misuse associated with this medication. Additionally, there are no concerns regarding dependence (a condition where the body becomes reliant on a substance) or any explicit instructions advising against its use. Always consult with your healthcare provider if you have any questions or concerns about your treatment.

Side Effects

Before using this medication, it's important to consult with your doctor if you have kidney disease or are on a magnesium-restricted diet. Additionally, if you are taking any prescription medications, check with your doctor or pharmacist, as antacids can interact with some of these drugs.

If your symptoms persist for more than two weeks, you should stop using the medication and seek medical advice.

Warnings and Precautions

Before using this medication, it's important to consult your doctor if you have kidney disease or are on a magnesium-restricted diet. Additionally, if you are taking any prescription medications, check with your doctor or pharmacist first, as antacids can interact with certain drugs.

Keep this medication out of reach of children. If your symptoms persist for more than two weeks, stop using the product and contact your doctor for further guidance.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to err on the side of caution when it comes to your health. Remember, if you have any concerns or questions about your medication, don't hesitate to reach out to your healthcare provider for guidance.

Pregnancy Use

If you are pregnant or planning to become pregnant, it’s important to consult your doctor before using this product. While there are no specific warnings or contraindications noted for its use during pregnancy, the safety and effectiveness of this product in pregnant women have not been established. Always prioritize your health and the health of your baby by seeking professional medical advice.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. This means that it is generally considered safe for you to use without concerns about it affecting your breast milk or posing risks to your infant. Always consult with your healthcare provider if you have any questions or concerns about your specific situation.

Pediatric Use

If you are considering this medication for your child, it's important to know that it is not recommended for children under 12 years old without consulting a doctor first. For those aged 12 and older, the typical dosage is 2 to 4 teaspoonfuls taken between meals or at bedtime, but you should always follow your doctor's guidance.

Be cautious not to exceed 12 teaspoonfuls in a 24-hour period, and avoid using the maximum dosage for more than two weeks. Additionally, make sure to keep this medication out of reach of younger children to ensure their safety.

Geriatric Use

If you are an older adult or caring for one, it's important to consult with a doctor before using this medication, especially if there is a history of kidney disease (a condition where the kidneys do not function properly). Additionally, if you are taking any prescription medications, check with your doctor or pharmacist first, as antacids can interact with certain drugs.

For adults and children aged 12 and older, the recommended dosage is 2 to 4 teaspoonfuls taken between meals or at bedtime, unless directed otherwise by a healthcare professional. Be cautious not to exceed 12 teaspoonfuls in a 24-hour period, and avoid using the maximum dosage for more than two weeks. If the user is under 12 years old, please consult a doctor for guidance.

Renal Impairment

If you have kidney disease, it's important to consult your doctor before using this medication. Your healthcare provider can help determine if it's safe for you and if any adjustments to your dosage are necessary. Always prioritize open communication with your doctor regarding your kidney health to ensure the best care.

Hepatic Impairment

If you have liver 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 standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, and your healthcare team is there to support you.

Drug Interactions

It's important to talk to your doctor or pharmacist before using this medication, especially if you are currently taking any prescription drugs. Some antacids can interact with these medications, which may affect how well they work or increase the risk of side effects.

Always keep your healthcare provider informed about all the medications you are taking, including over-the-counter products, to ensure your safety and the effectiveness of your treatment.

Storage and Handling

To ensure the best performance of your product, store it at room temperature. It's important to protect it from freezing, as extreme cold can damage it. Always keep the container tightly closed when not in use to maintain its integrity and safety. Following these simple guidelines will help you use the product effectively and safely.

Additional Information

You should take this medication orally. Before using it, consult your doctor if you have kidney disease or are on a magnesium-restricted diet, as these conditions may affect your treatment. Additionally, if you are taking any prescription medications, it's important to check with your doctor or pharmacist first, since antacids can interact with some drugs. If your symptoms persist for more than two weeks, stop using the medication and seek medical advice.

FAQ

What symptoms does this drug relieve?

This drug relieves heartburn, sour stomach, acid indigestion, and symptoms referred to as gas.

What should I do before using this drug?

Ask a doctor before use if you have kidney disease or a magnesium-restricted diet, and consult a doctor or pharmacist if you are taking a prescription drug.

What is the recommended dosage for adults and children 12 years and older?

You should take 2 to 4 teaspoonfuls between meals, at bedtime, or as directed by a doctor, but do not exceed 12 teaspoonfuls in 24 hours.

What should I do if symptoms last more than 2 weeks?

Stop use and ask a doctor if your symptoms last more than 2 weeks.

Is this drug safe to use during pregnancy?

You should ask a doctor before use if you are pregnant or plan to become pregnant, as safety and efficacy in pregnant women have not been established.

Can children under 12 years use this drug?

Children under 12 years should ask a doctor before using this drug.

How should I store this drug?

Store at room temperature, protect from freezing, and keep tightly closed.

What should I do if I have kidney disease?

You should ask a doctor before using this drug if you have kidney disease.

What precautions should I take regarding drug interactions?

Ask a doctor or pharmacist before use if you are taking a prescription drug, as antacids may interact with certain medications.

What is the maximum dosage duration for this drug?

Do not use the maximum dosage for more than 2 weeks.

Packaging Info

Below are the non-prescription pack sizes of Almacone Double Strength (aluminum hydroxide, magnesium hydroxide, dimethicone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Almacone Double Strength.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The drug is identified by SPL Code 34089-3 and is presented as a white to off-white, round, biconvex tablet, which is debossed with "R" on one side and "D" on the other. Each tablet contains 500 mg of Acetaminophen. The formulation includes the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, iron oxide red, and iron oxide yellow.

Uses and Indications

This drug is indicated for the relief of heartburn, sour stomach, acid indigestion, and symptoms referred to as gas.

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

Dosage and Administration

Healthcare professionals should instruct patients to shake the product well before use.

For adults and children aged 12 years and older, the recommended dosage is 2 to 4 teaspoonfuls taken between meals, at bedtime, or as directed by a physician. It is important to note that patients should not exceed 12 teaspoonfuls within a 24-hour period, and the maximum dosage should not be used for more than 2 weeks.

For children under 12 years of age, it is advised to consult a physician for appropriate dosing recommendations.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence.

Warnings and Precautions

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

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. These conditions may influence the safety and efficacy of the product.

Additionally, it is crucial to recommend that patients speak with their healthcare provider or pharmacist before using this product if they are currently taking any prescription medications. Antacids have the potential to interact with certain prescription drugs, which may lead to adverse effects or reduced therapeutic efficacy.

In the event that symptoms persist for more than two weeks, patients should discontinue use and seek medical advice. This precaution is essential to ensure that any underlying conditions are appropriately addressed.

It is also important to emphasize the need to keep this product out of reach of children to prevent accidental ingestion and potential harm.

No specific laboratory tests have been identified for monitoring during the use of this product. However, healthcare professionals should remain vigilant for any signs of adverse reactions or interactions, particularly in patients with pre-existing conditions or those on concurrent medications.

Side Effects

Patients should be aware of certain warnings associated with the use of this medication. It is advised to consult a doctor before use if there is a history of kidney disease or if the patient is on a magnesium-restricted diet. Additionally, patients should seek advice from a doctor or pharmacist prior to use if they are currently taking any prescription medications, as antacids may interact with specific prescription drugs.

In the event that symptoms persist for more than two weeks, patients are instructed to discontinue use and consult a doctor. This precaution is essential to ensure the safety and efficacy of the treatment.

Drug Interactions

Patients are advised to consult a healthcare professional, such as a doctor or pharmacist, prior to using antacids if they are currently taking any prescription medications. Antacids have the potential to interact with various prescription drugs, which may alter the effectiveness of the medications or lead to unintended side effects.

It is essential for healthcare providers to evaluate the specific medications involved to determine the need for dosage adjustments or enhanced monitoring during concurrent use.

Packaging & NDC

Below are the non-prescription pack sizes of Almacone Double Strength (aluminum hydroxide, magnesium hydroxide, dimethicone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Almacone Double Strength.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents and adults aged 12 years and older, the recommended dosage is 2 to 4 teaspoonfuls taken between meals, at bedtime, or as directed by a physician. It is important to note that the maximum dosage should not exceed 12 teaspoonfuls within a 24-hour period, and the maximum dosage should not be used for more than 2 weeks. Additionally, this product should be kept out of reach of children to ensure safety.

Geriatric Use

Elderly patients should consult a healthcare provider prior to use if they have a history of kidney disease, as this may influence the safety and efficacy of the treatment. 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 aged 12 years and older, the recommended dosage is 2 to 4 teaspoonfuls between meals, at bedtime, or as directed by a healthcare professional. It is crucial for elderly patients to adhere to the maximum dosage limit of 12 teaspoonfuls within a 24-hour period and to avoid using the maximum dosage for more than 2 weeks to mitigate the risk of adverse effects.

For children under 12 years of age, it is essential to consult a doctor before administration. This precaution is particularly important in the geriatric population, where careful monitoring and dose adjustments may be necessary to ensure safe and effective use of the medication.

Pregnancy

Pregnant patients or those planning to become pregnant should consult a healthcare professional before using this product. Currently, there are no specific warnings or contraindications associated with the use of this product during pregnancy. However, safety and efficacy in pregnant women have not been established, and caution is advised. It is essential for healthcare providers to evaluate the potential risks and benefits when considering this product for use in pregnant patients.

Lactation

There are no specific warnings or recommendations regarding the use of this product in lactating mothers. Additionally, there are no known concerns related to the potential for excretion in breast milk or associated risks for breastfed infants.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have a history of kidney disease. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the degree of impairment.

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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, ensuring adequate ventilation, and monitoring vital signs.

If available, specific antidotes or treatments should be administered according to established protocols. Additionally, contacting a poison control center for guidance on management strategies is recommended.

Documentation of the incident, including the substance involved, the amount ingested, and the time of ingestion, is crucial for effective treatment and follow-up care.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the potential risks associated with children accessing the medication, including serious health consequences. Providers should encourage patients to store the medication in a secure location and to be vigilant about monitoring its use.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It should be stored at room temperature, ensuring that it is protected from freezing. Additionally, it is essential to keep the container tightly closed to maintain the integrity of the product.

Additional Clinical Information

The route of administration for the medication is oral. Clinicians should advise patients to consult a doctor before use if they have kidney disease or are on a magnesium-restricted diet. Additionally, patients should seek guidance from a doctor or pharmacist if they are taking any prescription medications, as antacids may interact with certain drugs. If symptoms persist for more than two weeks, patients are instructed to discontinue use and consult a doctor.

Drug Information (PDF)

This file contains official product information for Almacone Double Strength, 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 Almacone Double Strength, 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.

Learn more in our Editorial Policy

Last AI update:

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.