Antacids
Antacids are over-the-counter (OTC) monograph drugs, meaning they've been evaluated by the FDA for safety and effectiveness and are generally safe for self-care. Antacids relieve heartburn (indigestion). They work by changing the stomach acid that causes heartburn, acid indigestion, and upset stomach. However, antacids don't address the root cause of these issues and shouldn't be used for prolonged periods without consulting a doctor.
| Active Ingredients | OTC Monograph Number |
|---|---|
| Basic aluminum carbonate gel | M001.11 (Part 331) |
| Basic aluminum carbonate gel | M001.11 (Part 331) |
| Aluminum hydroxide | M001.11 (Part 331) |
| Dihydroxyaluminum aminoacetate and dihydroxyaluminum aminoacetic acid | M001.11 (Part 331) |
| Aluminum phosphate gel when used as part of an antacid combination product and contributing at least 25 percent of the total acid-neutralizing capacity; maximum daily dosage limit is 8 grams. | M001.11 (Part 331) |
| Dihydroxyaluminum sodium carbonate | M001.11 (Part 331) |
| Bicarbonate-containing active ingredients: Bicarbonate ion | M001.11 (Part 331) |
| Bismuth aluminate | M001.11 (Part 331) |
| Bismuth carbonate | M001.11 (Part 331) |
| Bismuth subcarbonate | M001.11 (Part 331) |
| Bismuth subgallate | M001.11 (Part 331) |
| Bismuth subnitrate | M001.11 (Part 331) |
| Calcium-containing active ingredients (Calcium, as carbonate or phosphate; maximum daily dosage limit 160 mEq calcium) | M001.11 (Part 331) |
| Citrate-containing active ingredients (Citrate ion, as citric acid or salt; maximum daily dosage limit 8 grams.) | M001.11 (Part 331) |
| Glycine (aminoacetic acid) | M001.11 (Part 331) |
| Hydrate magnesium aluminate activated sulfate | M001.11 (Part 331) |
| Magaldrate | M001.11 (Part 331) |
| Magnesium aluminosilicates | M001.11 (Part 331) |
| Magnesium carbonate | M001.11 (Part 331) |
| Magnesium glycinate | M001.11 (Part 331) |
| Magnesium hydroxide | M001.11 (Part 331) |
| Magnesium oxide | M001.11 (Part 331) |
| Magnesium trisilicate | M001.11 (Part 331) |
| Milk solids, dried | M001.11 (Part 331) |
| Aluminum phosphate | M001.11 (Part 331) |
| Mono- or dibasic calcium salt | M001.11 (Part 331) |
| Tricalcium phosphate | M001.11 (Part 331) |
| Potassium bicarbonate (or carbonate when used as a component of an effervescent preparation) | M001.11 (Part 331) |
| Sodium potassium tartrate | M001.11 (Part 331) |
| Sodium bicarbonate (or carbonate when used as a component of an effervescent preparation) | M001.11 (Part 331) |
| Sodium potassium tartrate | M001.11 (Part 331) |
| Magnesium aluminosilicates | M001.11 (Part 331) |
| Magnesium trisilicate | M001.11 (Part 331) |
| Tartrate-containing active ingredients (Tartaric acid or its salts; maximum daily dosage limit 200 mEq (15 grams) of tartrate.) | M001.11 (Part 331) |
These are not complete list of ingredients in FDA OTC drug monograph. The status of ingredient in OTC monograph may change please contact FDA for updated information.
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