Symptom checker
Select audience type

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

ADD CONDITION

items per page

Antacid Double Strength

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredients
  • Dimethicone 40 mg/5 mL
  • Aluminum Hydroxide 400 mg/5 mL
  • Magnesium Hydroxide 400 mg/5 mL
Other brand names
Dosage form
Liquid
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 1999
Label revision date
April 30, 2018
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
Dosage form
Liquid
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 1999
Label revision date
April 30, 2018
Manufacturer
Rij Pharmaceutical Corporation
Registration number
part332
NDC root
53807-158
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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

This medication is designed to help relieve discomfort caused by heartburn, acid indigestion, and sour stomach. If you've ever felt the unpleasant effects of overindulging in food and drink, this drug can also assist in alleviating those symptoms, including gas and upset stomach. It works by addressing the underlying causes of these digestive issues, providing you with relief when you need it most.

Uses

If you're experiencing discomfort from heartburn, acid indigestion, or a sour stomach, this medication can help relieve those symptoms. It’s also effective for easing the discomfort associated with gas and an upset stomach, making it a good choice if you've overindulged in food and drink.

You can rely on this medication to provide relief from these common digestive issues, helping you feel more comfortable after meals or during times of digestive distress.

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 teaspoonsful of the medication between meals or at bedtime, or as your doctor has instructed. However, be careful not to exceed 12 teaspoonsful in a 24-hour period, and avoid using the maximum dosage for more than 2 weeks.

If your child is under 12 years old, it’s important to consult a doctor before giving them this medication. Always follow your healthcare provider's advice to ensure safe and effective use.

What to Avoid

It's important to be aware of certain guidelines when using this medication. If you accidentally take too much, seek medical help or contact a Poison Control Center right away. Additionally, if your symptoms persist for more than two weeks, stop using the medication and consult your doctor for further advice.

Currently, there are no specific contraindications, controlled substance classifications, or noted risks of abuse or dependence associated with this medication. Always prioritize your health and safety by following these instructions closely.

Side Effects

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, as antacids can interact with some of these drugs.

If your symptoms persist for more than two weeks, stop using the medication and seek medical advice. Always keep this product out of reach of children, and in the event of an accidental overdose, contact a medical professional or Poison Control Center right away.

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.

If your symptoms persist for more than two weeks, stop using the medication and reach out to your doctor for further guidance. In the event of an accidental overdose, seek emergency medical help or contact a Poison Control Center right away. Always keep this medication out of reach of children to ensure their safety.

Overdose

If you suspect an accidental overdose, it’s crucial to seek medical help right away or contact a Poison Control Center. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Don’t wait for symptoms to worsen; getting prompt assistance can be vital for your safety. Always keep emergency contact numbers handy, and remember that acting quickly can make a significant difference in an overdose situation.

Pregnancy Use

When it comes to using this medication during pregnancy, there are no specific safety concerns or special precautions mentioned. Additionally, there are no dosage modifications required for pregnant individuals. However, it's always important to consult with your healthcare provider before starting any new medication if you are pregnant or planning to become pregnant. They can provide personalized advice based on your health and circumstances.

Lactation Use

When it comes to breastfeeding, it's important to be aware that there are no specific guidelines or statements regarding nursing mothers or lactation (the process of producing milk). This means that if you are breastfeeding, you should consult with your healthcare provider for personalized advice and to discuss any medications or treatments you may be considering. They can help you understand any potential effects on your milk production or your baby's health. Always prioritize open communication with your healthcare team to ensure the best outcomes for you and your infant.

Pediatric Use

If you are considering this medication for your child, it's important to know that children under 12 years old should consult a doctor before use. For those aged 12 and older, the recommended dosage is 2 to 4 teaspoonsful taken between meals or at bedtime, but be sure not to exceed 12 teaspoonsful in a 24-hour period.

Additionally, it's crucial to avoid using the maximum dosage for more than two weeks. Always follow your healthcare provider's instructions to ensure safe and effective use.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that healthcare providers may not have tailored guidelines for elderly patients.

If you or a loved one is an older adult considering this medication, it’s important to discuss any potential risks and benefits with your healthcare provider. They can help determine the best approach based on individual health needs and circumstances.

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 your kidney health and follow your doctor's guidance closely.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines, dosage adjustments, or special monitoring instructions provided for your condition in the available information. This means that the medication may not have been studied in depth for its effects on individuals with liver impairment.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver health and medication use. They can help ensure that your treatment is safe and effective based on your individual health needs.

Drug Interactions

It's important to be aware that antacids, which are commonly used to relieve heartburn and indigestion, can interact with some prescription medications. This means that taking antacids at the same time as certain drugs may affect how well those medications work.

To ensure your safety and the effectiveness of your treatments, always discuss any medications you are taking, including over-the-counter products like antacids, with your healthcare provider. They can help you understand potential interactions and adjust your treatment plan if necessary.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at room temperature, ideally between 15º - 30ºC (59º - 86ºF). Make sure to keep the container tightly closed to prevent contamination and protect it from freezing, as extreme temperatures can affect its performance.

Before using the product, check the breakaway band on the cap. If it is broken or missing, do not use the product, as this indicates it may have been tampered with. Following these guidelines will help you handle the product safely and maintain its integrity.

Additional Information

You should take this medication as directed by your physician. For adults and children aged 12 years and older, the recommended dosage is 2 to 4 teaspoonsful between meals and at bedtime, but do not exceed 12 teaspoonsful in a 24-hour period. It's important not to use the maximum dosage for more than 2 weeks. If you are giving this medication to a child under 12 years old, consult a doctor first.

Before using this medication, ask your doctor or pharmacist if you are currently taking any prescription drugs, as antacids can interact with some medications. If your symptoms persist for more than 2 weeks, stop using the medication and consult a doctor. In the event of an accidental overdose, seek medical help or contact a Poison Control Center immediately.

FAQ

What symptoms does this drug relieve?

This drug relieves heartburn, acid indigestion, sour stomach, and associated symptoms of gas and upset stomach, as well as overindulgence of food and drink.

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

Adults and children 12 years and older should take 2 to 4 teaspoonsful between meals, at bedtime, or as directed by a physician, but not more than 12 teaspoonsful in a 24-hour period.

How long can I use the maximum dosage?

You should not use the maximum dosage for more than 2 weeks.

What should I do if I accidentally take too much?

In case of accidental overdose, get medical help or contact a Poison Control Center immediately.

Are there any warnings I should be aware of?

You should ask a doctor before use if you have kidney disease or are on a magnesium-restricted diet, and consult a doctor or pharmacist if you are taking a prescription drug, as antacids may interact with certain medications.

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

You should stop use and ask a doctor if your symptoms last for more than 2 weeks.

Is this drug safe to use during pregnancy?

The provided text does not specify any safety concerns regarding use during pregnancy.

What precautions should I take when using this drug?

Keep this drug out of reach of children and do not use if the tamper-evident band on the cap is broken or missing.

Packaging Info

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

Packaging configurations for Antacid Double Strength.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No relevant information is available for SPL code 34089-3.

Uses and Indications

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

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

For adults and children aged 12 years and older, the recommended dosage is 2 to 4 teaspoonsful taken between meals, at bedtime, or as directed by a physician. It is important to note that patients should not exceed a maximum dosage of 12 teaspoonsful within a 24-hour period. Additionally, 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 before administration.

Contraindications

There are no contraindications listed for this product.

In the event of an accidental overdose, it is imperative to seek medical assistance or contact a Poison Control Center immediately. Additionally, if symptoms persist for more than two weeks, discontinuation of use is advised, and consultation with a healthcare professional is recommended.

Warnings and Precautions

Healthcare professionals should advise patients 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 treatment.

It is also essential to recommend that patients seek guidance from a healthcare provider or pharmacist if they are currently taking any prescription medications. Antacids have the potential to interact with certain prescription drugs, which could lead to adverse effects or diminished therapeutic outcomes.

Patients should be instructed to discontinue use and consult a physician if symptoms persist for more than two weeks. Prolonged symptoms may indicate an underlying condition that requires further evaluation.

In the event of an accidental overdose, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay. Prompt action is critical in managing potential overdose situations.

General precautions include ensuring that the product is kept out of reach of children to prevent accidental ingestion and potential harm.

Side Effects

Patients should be aware of several important 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 taking prescription medications should seek guidance from a healthcare professional or pharmacist, as antacids may interact with certain drugs.

In the event that symptoms persist for more than two weeks, patients are instructed to discontinue use and consult a doctor. It is crucial to keep this medication out of reach of children. In cases of accidental overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Drug Interactions

Antacids have the potential to interact with various prescription medications, which may affect their absorption and efficacy. It is advisable for healthcare professionals to monitor patients closely when antacids are co-administered with other drugs.

In particular, the timing of antacid administration relative to other medications should be considered to minimize interaction risks. Patients may be instructed to separate the dosing of antacids and other medications by at least two hours to enhance therapeutic outcomes and reduce the likelihood of diminished drug effectiveness.

Packaging & NDC

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

Packaging configurations for Antacid Double Strength.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a physician before use. For adolescents aged 12 years and older, the recommended dosage is 2 to 4 teaspoonsful taken between meals or at bedtime, or as directed by a healthcare professional.

It is important to note that the maximum dosage should not exceed 12 teaspoonsful within a 24-hour period. Additionally, the maximum dosage should not be used for more than 2 weeks to ensure safety and efficacy.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients may use this medication as no specific safety concerns regarding pregnancy have been detailed in the prescribing information. There are no dosage modifications recommended for pregnant individuals, nor are there any special precautions regarding its use during pregnancy. Healthcare professionals should continue to evaluate the benefits and risks when prescribing this medication to women of childbearing potential.

Lactation

There are no specific statements regarding the use of this medication in nursing mothers or its effects during lactation. Consequently, healthcare professionals should exercise caution when prescribing this medication to lactating mothers, as the potential risks and benefits have not been clearly established. It is advisable to monitor breastfed infants for any adverse effects if the mother is treated with this medication.

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

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise caution and consider the lack of data when prescribing this medication to patients with liver problems.

Overdosage

In the event of an accidental overdose, it is imperative to seek medical assistance promptly. Healthcare professionals are advised to contact a Poison Control Center immediately for guidance on managing the situation effectively.

Symptoms of overdose may vary depending on the specific substance involved; therefore, a thorough assessment of the patient's condition is essential. Healthcare providers should monitor the patient closely for any signs of adverse reactions or complications that may arise from the overdose.

Management of an overdose typically involves supportive care and symptomatic treatment. The specific interventions may depend on the nature and severity of the symptoms presented. It is crucial to follow established protocols and guidelines for the management of overdose cases to ensure optimal patient outcomes.

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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the provided text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an accidental overdose. It is important for patients to be informed that they should discontinue use and consult a doctor if their symptoms persist for more than two weeks.

Patients should be encouraged to consult with their healthcare provider before using this medication if they have a history of kidney disease or if they are on a magnesium-restricted diet. Additionally, healthcare providers should recommend that patients 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 a tamper-evident container. It should not be used if the breakaway band on the cap is broken or missing.

For optimal storage, the product must be kept at room temperature, within the range of 15º to 30ºC (59º to 86ºF). It is essential to keep the container tightly closed to maintain product integrity. Additionally, the product should be protected from freezing to ensure its efficacy and safety.

Additional Clinical Information

Patients aged 12 years and older are advised to take 2 to 4 teaspoonsful of the medication between meals or at bedtime, or as directed by a physician, with a maximum dosage of 12 teaspoonsful within a 24-hour period. It is important not to exceed the maximum dosage for more than 2 weeks. For children under 12 years, consultation with a doctor is recommended prior to use.

Clinicians should counsel patients to consult a doctor or pharmacist before use if they are currently taking prescription medications, as antacids may interact with certain drugs. Patients should discontinue use and seek medical advice if symptoms persist for more than 2 weeks. In the event of an accidental overdose, immediate medical assistance or contact with a Poison Control Center is essential.

Drug Information (PDF)

This file contains official product information for Antacid 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 Antacid 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.