Mintox Plus Chewable Tablets

Manufacturer MAJOR Active Ingredient Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone Chewable Tablets(a LOO mi num hye DROKS ide, mag NEE zhum hye DROKS ide, & sye METH i kone) Pronunciation MINT-oks PLUS CHEW-uh-bul TAB-lets (a-LOO-mi-num hye-DROK-side, mag-NEE-zhum hye-DROK-side, & sye-METH-i-kone)
It is used to ease too much gas in the stomach.It is used to treat heartburn and upset stomach.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Antacid, Antiflatulent
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Pharmacologic Class
Antacid (Aluminum/Magnesium salts), Antiflatulent (Silicone-based defoaming agent)
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Pregnancy Category
Category C
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FDA Approved
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Mintox Plus is an over-the-counter medicine used to relieve heartburn, indigestion, sour stomach, and gas. It contains two antacids (aluminum hydroxide and magnesium hydroxide) that work by neutralizing stomach acid, and simethicone, which helps break up gas bubbles in your stomach and intestines.
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How to Use This Medicine

Taking Your Medication Correctly
To get the most benefit from your medication, take it exactly as directed by your doctor. Carefully read all the information provided with your prescription, and follow the instructions closely. Take your medication after meals and at bedtime, or as instructed by your doctor. Be sure to chew the medication thoroughly before swallowing.

Storing and Disposing of Your Medication
To maintain the quality and safety of your medication, store it at room temperature with the lid tightly closed. Keep it in a dry place, away from the bathroom. Store all medications in a secure location, out of the reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless specifically instructed to do so. Instead, check with your pharmacist for guidance on the best disposal method. You may also want to inquire about drug take-back programs in your area.

Missing a Dose
If you take your medication on a regular schedule, take a missed dose as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your normal dosing schedule. Do not take two doses at the same time or take extra doses. If you take your medication as needed, be sure not to exceed the frequency recommended by your doctor.
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Lifestyle & Tips

  • Chew tablets thoroughly before swallowing for best results.
  • Take with a full glass of water if desired, but not required.
  • Avoid trigger foods that cause heartburn (e.g., spicy foods, fatty foods, caffeine, alcohol, citrus).
  • Eat smaller, more frequent meals.
  • Avoid lying down immediately after eating.
  • Elevate the head of your bed if heartburn is worse at night.
  • Do not use for more than 2 weeks without consulting a doctor.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: 2-4 chewable tablets between meals, at bedtime, or as directed by a physician. Do not exceed 12 tablets in 24 hours.
Dose Range: 2 - 4 mg

Condition-Specific Dosing:

heartburn: 2-4 tablets as needed
indigestion: 2-4 tablets as needed
gas: 2-4 tablets as needed
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established for this specific combination; consult physician for children under 12 years.
Adolescent: 12 years and older: Same as adult dosing.
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Dose Adjustments

Renal Impairment:

Mild: Use with caution; monitor for electrolyte imbalances.
Moderate: Avoid use or use with extreme caution due to risk of aluminum and magnesium accumulation.
Severe: Contraindicated due to risk of aluminum and magnesium toxicity (hypermagnesemia, aluminum osteodystrophy, encephalopathy).
Dialysis: Contraindicated.

Hepatic Impairment:

Mild: No specific adjustment needed.
Moderate: No specific adjustment needed.
Severe: No specific adjustment needed.

Pharmacology

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Mechanism of Action

Aluminum Hydroxide and Magnesium Hydroxide act as antacids by neutralizing gastric acid, increasing gastric pH. Aluminum hydroxide also has astringent and constipating properties, while magnesium hydroxide has laxative properties, often balancing each other in combination products. Simethicone is an antiflatulent that works by reducing the surface tension of gas bubbles in the gastrointestinal tract, causing them to coalesce and be more easily expelled.
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Pharmacokinetics

Absorption:

Bioavailability: Aluminum Hydroxide: <1% (absorbed); Magnesium Hydroxide: 15-30% (absorbed); Simethicone: Not absorbed
Tmax: Aluminum Hydroxide/Magnesium Hydroxide: Rapid onset (minutes); Simethicone: Not applicable (local action)
FoodEffect: Taken after meals or at bedtime for prolonged effect; food may delay onset but prolong duration.

Distribution:

Vd: Not applicable for local action; absorbed ions distribute throughout extracellular fluid.
ProteinBinding: Not significant for therapeutic action; absorbed ions bind to various proteins.
CnssPenetration: Limited for absorbed ions; none for Simethicone.

Elimination:

HalfLife: Not applicable for local action; absorbed Aluminum and Magnesium are renally excreted (variable, dependent on renal function).
Clearance: Not applicable for local action; absorbed Aluminum and Magnesium are renally cleared.
ExcretionRoute: Unabsorbed Aluminum and Magnesium are excreted in feces. Absorbed Aluminum and Magnesium are excreted renally. Simethicone is excreted unchanged in feces.
Unchanged: Aluminum Hydroxide: >99% (unabsorbed); Magnesium Hydroxide: 70-85% (unabsorbed); Simethicone: 100%
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Pharmacodynamics

OnsetOfAction: Antacids: Within 5-15 minutes; Simethicone: Within 30 minutes.
PeakEffect: Antacids: 30-60 minutes; Simethicone: 1-3 hours.
DurationOfAction: Antacids: 1-3 hours (on empty stomach), 3-4 hours (after meals); Simethicone: 3-6 hours.

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. Immediately contact your doctor or seek medical attention if you notice any of the following symptoms, which could be signs of a serious allergic reaction:

Rash
Hives
Itching
Red, swollen, blistered, or peeling skin (with or without fever)
Wheezing
Tightness in the chest or throat
Difficulty breathing, swallowing, or talking
Unusual hoarseness
Swelling of the mouth, face, lips, tongue, or throat

Other Possible Side Effects

Like all medications, this drug can cause side effects. Although many people may not experience any side effects or only have mild ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor for advice:

Diarrhea
* Constipation

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, don't hesitate to reach out to your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Symptoms worsen or persist for more than 2 weeks.
  • Difficulty swallowing or painful swallowing.
  • Vomiting blood or black, tarry stools.
  • Unexplained weight loss.
  • Chest pain accompanied by shortness of breath, sweating, or pain radiating to the arm, neck, or jaw (could be a sign of a heart attack).
  • Severe constipation or diarrhea.
  • Muscle weakness, confusion, or unusual tiredness (especially if you have kidney problems).
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
If you have kidney problems, as this may affect the use of this medication.

This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. Additionally, share any health problems you have, as they may interact with this medication.

To ensure your safety, always check with your doctor before starting, stopping, or changing the dose of any medication. This will help prevent potential interactions and ensure that it is safe for you to take this medication with your other drugs and health conditions.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you are following a low-magnesium diet, consult with your doctor to discuss any potential interactions. Do not exceed the prescribed duration of treatment with this drug, as directed by your doctor.

When taking this medication, be aware that it may interfere with the absorption of other oral medications. To minimize this interaction, your doctor may recommend taking other oral drugs at a different time than this medication. Consult with your doctor to determine the best schedule for your medications.

If you have phenylketonuria (PKU), a condition where the body cannot break down the amino acid phenylalanine, discuss this with your doctor before taking this medication. Some formulations of this drug may contain phenylalanine, which could exacerbate your condition.

Additionally, if you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor. It is crucial to discuss the potential benefits and risks of this medication to both you and your baby, and your doctor will help you make an informed decision.
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Overdose Information

Overdose Symptoms:

  • Severe constipation or diarrhea
  • Nausea, vomiting
  • Muscle weakness
  • Fatigue
  • Confusion
  • Slowed breathing
  • Irregular heartbeat (rare, with severe hypermagnesemia)
  • Kidney stones (with prolonged high dose aluminum)

What to Do:

If you suspect an overdose, contact a poison control center immediately (1-800-222-1222) or seek emergency medical attention.

Drug Interactions

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Contraindicated Interactions

  • Sodium Polystyrene Sulfonate (Kayexalate) - risk of metabolic alkalosis and intestinal necrosis (with aluminum hydroxide)
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Major Interactions

  • Tetracyclines (e.g., Doxycycline, Minocycline) - decreased absorption
  • Fluoroquinolones (e.g., Ciprofloxacin, Levofloxacin) - decreased absorption
  • Thyroid hormones (e.g., Levothyroxine) - decreased absorption
  • Bisphosphonates (e.g., Alendronate) - decreased absorption
  • Iron supplements - decreased absorption
  • Mycophenolate Mofetil - decreased absorption
  • Gabapentin - decreased absorption
  • Digoxin - decreased absorption
  • Phenytoin - decreased absorption
  • Azithromycin - decreased absorption
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Moderate Interactions

  • H2-receptor antagonists (e.g., Ranitidine, Famotidine) - altered absorption
  • Proton pump inhibitors (e.g., Omeprazole, Pantoprazole) - altered absorption
  • Salicylates (e.g., Aspirin) - increased renal excretion of salicylates due to urine alkalinization
  • Oral contraceptives - altered absorption (minor effect)
  • Corticosteroids - potential for decreased absorption
  • Ketoconazole/Itraconazole - decreased absorption (requires acidic environment)
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Minor Interactions

  • Other medications where absorption is pH-dependent or chelation can occur.

Monitoring

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Baseline Monitoring

Not typically required for OTC use.

Rationale: OTC product for symptomatic relief.

Timing: Not applicable

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Routine Monitoring

Symptom relief

Frequency: As needed

Target: Resolution of heartburn, indigestion, gas

Action Threshold: If symptoms persist for more than 2 weeks or worsen, consult a physician.

Bowel habits

Frequency: Daily during use

Target: Normal bowel movements

Action Threshold: If severe constipation (due to aluminum) or diarrhea (due to magnesium) occurs, discontinue use or adjust dose.

Electrolyte levels (Magnesium, Phosphate, Calcium)

Frequency: Not routinely for OTC use; consider in patients with renal impairment or prolonged high-dose use.

Target: Normal ranges

Action Threshold: Elevated magnesium, low phosphate, or altered calcium levels require medical evaluation.

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Symptom Monitoring

  • Heartburn relief
  • Indigestion relief
  • Gas/bloating reduction
  • Constipation (potential side effect of aluminum)
  • Diarrhea (potential side effect of magnesium)
  • Muscle weakness, fatigue, confusion (signs of hypermagnesemia or aluminum toxicity, especially in renal impairment)

Special Patient Groups

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Pregnancy

Generally considered safe for occasional use during pregnancy, but prolonged or high-dose use should be avoided due to potential for electrolyte imbalances (e.g., hypermagnesemia in the fetus if used near term) and aluminum accumulation. Consult a healthcare provider.

Trimester-Specific Risks:

First Trimester: Low risk with occasional use.
Second Trimester: Low risk with occasional use.
Third Trimester: Use with caution, especially near term, due to potential for hypermagnesemia in the neonate if mother has impaired renal function or takes high doses.
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Lactation

Considered compatible with breastfeeding. Minimal amounts of aluminum and magnesium are absorbed and excreted into breast milk, and simethicone is not absorbed. Infant exposure is expected to be negligible.

Infant Risk: Low risk.
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Pediatric Use

Not recommended for children under 12 years of age unless directed by a physician. Dosing for younger children must be carefully determined by a healthcare professional due to potential for electrolyte imbalances and aluminum toxicity, especially in infants and young children with immature renal function.

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Geriatric Use

Use with caution in elderly patients, especially those with pre-existing renal impairment, due to increased risk of aluminum and magnesium accumulation and associated toxicities (e.g., hypermagnesemia, aluminum osteodystrophy, encephalopathy). Monitor for changes in bowel habits and cognitive function.

Clinical Information

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Clinical Pearls

  • Chew tablets thoroughly for optimal effectiveness and faster onset of action.
  • Advise patients to separate administration of this antacid from other medications by at least 2-4 hours to minimize drug interactions.
  • Warn patients with renal impairment about the risks of aluminum and magnesium accumulation.
  • This combination product helps with both acid reflux symptoms and gas, offering broader relief than single-ingredient antacids.
  • Educate patients that while effective for symptomatic relief, antacids do not treat the underlying cause of frequent or severe heartburn; persistent symptoms warrant medical evaluation.
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Alternative Therapies

  • H2-receptor antagonists (e.g., Famotidine, Ranitidine)
  • Proton pump inhibitors (e.g., Omeprazole, Lansoprazole)
  • Alginate-based products (e.g., Gaviscon Liquid)
  • Lifestyle modifications (dietary changes, weight loss, avoiding triggers)
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Cost & Coverage

Average Cost: $5 - $15 per 30 tablets
Generic Available: Yes
Insurance Coverage: OTC (Over-The-Counter) - generally not covered by prescription plans, but may be eligible for FSA/HSA.
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General Drug Facts

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.