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Acid Reducer Complete

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Active ingredients
  • Famotidine 10 mg
  • Calcium Carbonate 800 mg
  • Magnesium Hydroxide 165 mg
Other brand names
Drug classes
Calculi Dissolution Agent, Histamine-2 Receptor Antagonist, Osmotic Laxative
Dosage form
Tablet, Chewable
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2025
Label revision date
August 27, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Famotidine 10 mg
  • Calcium Carbonate 800 mg
  • Magnesium Hydroxide 165 mg
Other brand names
Drug classes
Calculi Dissolution Agent, Histamine-2 Receptor Antagonist, Osmotic Laxative
Dosage form
Tablet, Chewable
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 2025
Label revision date
August 27, 2025
Manufacturer
Safeway
Registration number
ANDA077355
NDC root
21130-614
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

Signature SELECT® is a chewable tablet that helps relieve heartburn associated with acid indigestion and sour stomach. It features a dual action formula that combines an acid reducer and an antacid, providing complete relief in just one tablet. Each tablet contains 10 mg of famotidine (a medication that reduces stomach acid), 800 mg of calcium carbonate, and 165 mg of magnesium hydroxide, all in a pleasant berry flavor.

This product is designed to quickly alleviate discomfort from heartburn, making it a convenient option for those experiencing occasional acid-related issues. With 25 chewable tablets in each package, you can easily find relief whenever you need it.

Uses

You can use this medication to help relieve heartburn that comes with acid indigestion and a sour stomach. It works by addressing the discomfort associated with these conditions, making it easier for you to go about your day without the nagging sensation of heartburn.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects associated with this medication. This makes it a safer option for those who may be concerned about potential risks.

Dosage and Administration

When you need relief from your symptoms, and you are 12 years or older, take one chewable tablet. It's important to chew the tablet completely before swallowing it—do not swallow it whole. You should not take more than two chewable tablets in a 24-hour period to ensure your safety.

If you are caring for a child under 12 years old, it's best to consult a doctor before giving them this medication. This way, you can ensure they receive the appropriate care and dosage.

What to Avoid

You should avoid using this medication if you have difficulty swallowing food, are experiencing vomiting with blood, or have bloody or black stools, as these could indicate a serious health issue. It's important to consult your doctor if you encounter any of these symptoms. Additionally, do not use this medication in combination with other acid reducers, as this could lead to complications. Always prioritize your health and seek professional advice when needed.

Side Effects

You should be aware of some important side effects and warnings associated with this medication. If you are allergic to famotidine or other acid reducers, you should not use it. Additionally, avoid using this medication if you have difficulty swallowing, are vomiting blood, or have bloody or black stools, as these could indicate a serious health issue that requires medical attention.

Before using this medication, consult your doctor if you have experienced heartburn for more than three months, or if you have heartburn accompanied by symptoms like lightheadedness, sweating, or chest pain. Other concerning signs include frequent wheezing, unexplained weight loss, nausea, vomiting, stomach pain, or if you have kidney disease. If your heartburn persists or worsens, or if you find yourself needing to use this product for more than 14 days, stop using it and seek medical advice.

Warnings and Precautions

You should not use this medication if you are allergic to famotidine or other acid reducers. Additionally, avoid using it if you have difficulty swallowing, are vomiting blood, or have bloody or black stools, as these could indicate a serious health issue. It's also important not to combine this medication with other acid reducers.

Before using this medication, consult your doctor if you have had heartburn for more than three months, experience heartburn with symptoms like lightheadedness or chest pain, or have unexplained weight loss, nausea, or stomach pain. If you have kidney disease or are taking other prescription medications, check with your doctor or pharmacist first, as there may be interactions.

If your heartburn persists or worsens, or if you find you need to use this product for more than 14 days, stop using it and contact your doctor. In case of an overdose, seek emergency medical help immediately or call Poison Control at 1-800-222-1222.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. 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. Always prioritize your safety and the safety of others by acting quickly in these situations.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

If you have a child under 12 years old, it's important to consult a doctor before giving them this medication. For children aged 12 and older, the medication comes in chewable tablet form, which should not be swallowed whole. Instead, your child should chew the tablet completely before swallowing it to help relieve their symptoms.

Make sure they do not take more than 2 chewable tablets within a 24-hour period to avoid any potential risks. Always follow these guidelines to ensure safe and effective use for your child.

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, which can be important for ensuring safe and effective treatment.

If you or a caregiver are considering this medication for an older adult, it’s essential to consult with a healthcare professional. They can provide personalized advice and monitor for any potential issues, especially since older adults may have different health needs and responses to medications.

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 the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have hepatic impairment (liver issues).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

Drug Interactions

It's important to be aware that some common medications, like antacids and acid reducers, can interact with certain prescription drugs you may be taking. These interactions can affect how well your medications work or increase the risk of side effects.

To ensure your safety and the effectiveness of your treatment, always discuss any medications, including over-the-counter products, with your healthcare provider. They can help you understand potential interactions and make any necessary adjustments to your treatment plan.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20-25°C (68-77°F). It's important to keep it protected from moisture, as this can affect its effectiveness and safety.

When handling the product, always do so with clean hands and in a clean environment to maintain its integrity. Following these guidelines will help you use the product safely and effectively.

Additional Information

It's important to take a few precautions when using this medication. If you are pregnant or breastfeeding, make sure to consult with a healthcare professional before using it. Always read the directions and warnings on the label carefully, as they contain essential information about the medication.

Additionally, be sure to check the bottle for any important details that may affect your use of the product.

FAQ

What is Signature SELECT® used for?

Signature SELECT® relieves heartburn associated with acid indigestion and sour stomach.

What are the active ingredients in Signature SELECT®?

Each chewable tablet contains 10 mg of famotidine, 800 mg of calcium carbonate, and 165 mg of magnesium hydroxide.

How should I take Signature SELECT®?

Chew 1 tablet completely before swallowing. Do not swallow the tablet whole, and do not use more than 2 tablets in 24 hours.

Who should not use Signature SELECT®?

Do not use if you have trouble swallowing food, vomiting with blood, or bloody or black stools. These may indicate a serious condition.

Are there any allergies associated with Signature SELECT®?

Yes, do not use if you are allergic to famotidine or other acid reducers.

What should I do if my heartburn continues?

Stop using Signature SELECT® and consult a doctor if your heartburn continues or worsens, or if you need to take it for more than 14 days.

Can I use Signature SELECT® if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before using Signature SELECT®.

What flavor does Signature SELECT® come in?

Signature SELECT® has a berry flavor.

How should I store Signature SELECT®?

Store Signature SELECT® at 20-25°C (68-77°F) and protect it from moisture.

Packaging Info

Below are the non-prescription pack sizes of Acid Reducer Complete (famotidine, calcium carbonate and magnesium hydroxide). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Acid Reducer Complete.
Details

Drug Information (PDF)

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

View product document (PDF)

Uses and Indications

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

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

Dosage and Administration

Adults and children aged 12 years and over are instructed to chew 1 tablet completely before swallowing to relieve symptoms. It is essential that the tablet is not swallowed whole. The maximum recommended dosage is 2 chewable tablets within a 24-hour period.

For children under 12 years of age, it is advised to consult a physician before use.

Contraindications

Use is contraindicated in patients who experience difficulty or pain when swallowing food, vomiting blood, or passing bloody or black stools, as these symptoms may indicate a serious underlying condition requiring medical evaluation. Additionally, concurrent use with other acid-reducing medications is contraindicated.

Warnings and Precautions

Patients should be advised of the following warnings and precautions prior to the use of this medication.

Allergy Alert This medication should not be used by individuals who are allergic to famotidine or other acid reducers.

Contraindications The medication is contraindicated in patients experiencing difficulty or pain when swallowing food, vomiting with blood, or the presence of bloody or black stools, as these symptoms may indicate a serious underlying condition. Such patients should seek medical attention immediately. Additionally, this medication should not be used concurrently with other acid reducers.

Pre-Use Consultation Healthcare professionals should be consulted before use if the patient has experienced heartburn for more than three months, as this may suggest a more serious condition. Patients should also seek medical advice if they experience heartburn accompanied by lightheadedness, sweating, or dizziness; chest or shoulder pain with shortness of breath, sweating, or pain radiating to the arms, neck, or shoulders; frequent chest pain; frequent wheezing, particularly in conjunction with heartburn; unexplained weight loss; nausea or vomiting; stomach pain; or if they have a history of kidney disease.

Drug Interactions Patients should inform their healthcare provider or pharmacist if they are taking any prescription medications, as antacids and acid reducers may interact with certain drugs.

Monitoring and Discontinuation Patients are advised to discontinue use and consult a healthcare professional if heartburn persists or worsens, or if the medication is required for more than 14 days.

Emergency Situations In the event of an overdose, patients should seek emergency medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. Serious adverse reactions may occur, and individuals are advised to discontinue use and consult a healthcare professional if they experience any of the following symptoms: difficulty or pain when swallowing food, vomiting that includes blood, or the presence of bloody or black stools, as these may indicate a serious underlying condition.

Additionally, patients should not use this medication if they have a known allergy to famotidine or other acid reducers. It is also contraindicated for use in conjunction with other acid-reducing medications.

Before initiating treatment, patients are encouraged to consult a healthcare provider if they have experienced heartburn for more than three months, as this may signal a more serious condition. Other concerning symptoms that warrant medical consultation include heartburn accompanied by lightheadedness, sweating, or dizziness; chest pain or shoulder pain accompanied by shortness of breath, sweating, or pain radiating to the arms, neck, or shoulders; frequent chest pain; frequent wheezing, particularly in conjunction with heartburn; unexplained weight loss; nausea or vomiting; stomach pain; or a history of kidney disease.

Patients should also seek medical advice if their heartburn persists or worsens, or if they find it necessary to use this product for more than 14 days.

Drug Interactions

Antacids and acid-reducing agents may interact with various prescription medications, potentially affecting their absorption and efficacy. It is advisable to monitor the timing of administration when these agents are used concurrently with other drugs.

For optimal therapeutic outcomes, healthcare professionals should consider adjusting the timing of doses to minimize interaction risks. Specifically, it is recommended that antacids and acid reducers be administered at least two hours apart from other medications to reduce the likelihood of altered absorption. Regular monitoring of the patient's response to therapy is also suggested to ensure the effectiveness of the prescribed regimen.

Packaging & NDC

Below are the non-prescription pack sizes of Acid Reducer Complete (famotidine, calcium carbonate and magnesium hydroxide). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Acid Reducer Complete.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents and children aged 12 years and older, it is important to note that the tablet must not be swallowed whole; it should be chewed completely before swallowing. To alleviate symptoms, patients in this age group may chew 1 tablet prior to swallowing, with a maximum dosage of 2 chewable tablets within 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers should consider individual circumstances and the specific health needs of the patient when making recommendations.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication 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 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 this medication. Consequently, there are no 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 overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Healthcare professionals should advise patients or caregivers to call the Poison Control Center at 1-800-222-1222 for guidance.

Prompt intervention is crucial in managing overdose situations, as timely medical support can significantly influence 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 include supportive care and symptomatic treatment as necessary. Healthcare providers are encouraged to follow established protocols for overdose management, which may involve decontamination, administration of antidotes if applicable, and continuous monitoring of vital signs.

It is essential to document the details of the overdose, including the substance, amount ingested, time of ingestion, and any symptoms presented, to facilitate appropriate treatment and follow-up care.

Nonclinical Toxicology

There are no teratogenic effects observed in the studies conducted. Additionally, no non-teratogenic effects have been reported. The nonclinical toxicology data does not provide any further information regarding animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. Patients should be informed not to use the product if they experience difficulty or pain when swallowing food, vomiting blood, or passing bloody or black stools, as these symptoms may indicate a serious underlying condition that requires medical evaluation.

It is important to counsel patients against using this product in conjunction with other acid reducers. Providers should instruct patients to discontinue use and consult a doctor if their heartburn persists or worsens. Additionally, patients should be advised to stop using the product and seek medical advice if they find it necessary to take it for more than 14 days.

Patients should be encouraged to consult a doctor before using the product if they have experienced heartburn for over three months, as this may signal a more serious condition. They should also be advised to seek medical attention if they experience heartburn accompanied by lightheadedness, sweating, or dizziness, or if they have chest pain or shoulder pain along with shortness of breath, sweating, or pain radiating to the arms, neck, or shoulders.

Furthermore, patients should be instructed to consult a doctor if they frequently experience chest pain, wheezing (especially in conjunction with heartburn), unexplained weight loss, nausea, vomiting, or stomach pain. Those with a history of kidney disease should also be advised to seek medical guidance before using the product.

Lastly, healthcare providers should recommend that patients consult a doctor or pharmacist prior to use if they are currently taking any prescription medications, as antacids and acid reducers may interact with certain drugs.

Storage and Handling

The product is supplied in packaging that ensures its integrity during storage and handling. It should be stored at a temperature range of 20-25°C (68-77°F) to maintain its efficacy. Additionally, it is essential to protect the product from moisture to prevent degradation. Proper adherence to these storage conditions will help ensure the product remains effective and safe for use.

Additional Clinical Information

Patients are advised to consult a health professional prior to use if they are pregnant or breastfeeding. It is essential for patients to read the directions and warnings provided before use, as well as to review the information contained on the bottle, which includes important details regarding the product.

Drug Information (PDF)

This file contains official product information for Acid Reducer Complete, 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 Acid Reducer Complete, 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

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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.