{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-11", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "spl_product_data_elements": [ "Mylanta Maximum Strength Classic Flavor Antacid and Anti Gas Aluminum hydroxide Magnesium hydroxide and Simethicone BENZYL ALCOHOL CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM GLYCERIN MICROCRYSTALLINE CELLULOSE WATER SODIUM CARBONATE SORBITOL SUCRALOSE XANTHAN GUM ALUMINUM HYDROXIDE ALUMINUM HYDROXIDE MAGNESIUM HYDROXIDE MAGNESIUM CATION DIMETHICONE DIMETHICONE OFF WHITE" ], "spl_unclassified_section": [ "Drug Facts", "Other information each 10 mL dose contains: magnesium 340 mg; sodium 7 mg store between 20-25°C (68-77°F), do not freeze." ], "active_ingredient": [ "Active ingredients (in each 10 mL dose) Aluminum hydroxide (equivalent to dried gel, USP) 800 mg Magnesium hydroxide 800 mg Simethicone 80 mg" ], "purpose": [ "Purpose Antacid Antacid Anti-gas" ], "indications_and_usage": [ "Uses relieves: heartburn pressure and bloating commonly referred to as gas acid indigestion sour stomach upset stomach due to these symptoms overindulgence in food and drink" ], "warnings": [ "Warnings Ask a doctor before use if you have • kidney disease • a magnesium restricted diet Ask a doctor before use if you have • kidney disease • a magnesium restricted diet Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs. Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away at 1-800-222-1222" ], "ask_doctor": [ "Ask a doctor before use if you have • kidney disease • a magnesium restricted diet" ], "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away at 1-800-222-1222" ], "dosage_and_administration": [ "Directions shake well before use measure with dosing cup provided adults and children 12 years and over : 10 mL-20 mL (1-2 doses) between meals, at bedtime or as directed by a doctor do not take more than 60 mL (6 doses) in any 24- hour period do not use the maximum dosage for more than 2 weeks children under 12 years : ask a doctor mL= milliliter" ], "inactive_ingredient": [ "Inactive ingredients benzyl alcohol, carboxymethylcellulose sodium, flavors, glycerin, microcrystalline cellulose, purified water, sodium carbonate, sorbitol, sucralose, xanthan gum" ], "questions": [ "Questions or comment? call 1-844-695-6624 toll free (English and Spanish)" ], "package_label_principal_display_panel": [ "Principal Display Panel MYLANTA ® ANTACID + ANTI-GAS Alcohol 0.2% MAXIMUM STRENGTH WORKS ON CONTACT! Tough on Heartburn Gentle on Your Body SMOOTH CREAMY TASTE Classic Flavor 12 FL OZ (355mL) Also try Mylanta Maximum Strength Vanilla Caramel Flavor and Mylanta Tonight, with its soothing taste of Honey-Chamomile, is perfect for heartburn relief after dinner and Mylanta GasMinis ̶ great- tasting mini- tablets that relieve gas symptoms fast The coating, acid-neutralizing power of Maximum Strength Mylanta ® starts to work on contact. It helps soothe and relieve heartburn, acid indigestion, and bothersome gas symptoms so you can feel better fast. Tough on heartburn and gas, Mylanta works at the source of symptoms. It is gentle on your body with a great-tasting flavor, and can be used as directed every day. Multi-symptom relief Extra coating power Paraben- free Active ingredients: Aluminum hydroxide, Magnesium hydroxide, Simethicone TAMPER-EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING Mylanta is a registered trademark of McNeil Consumer Pharmaceuticals Co. infirst + HEALTHCARE Manufactured for: Infirst Healthcare Inc. Westport, CT 06880 © 2017 Infirst Healthcare Inc. Mylanta.com Mylanta Maximum Strength Classic Flavor 12 FL OZ" ], "package_label_principal_display_panel_table": [ "
TAMPER-EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING
" ], "set_id": "56853b20-a2aa-4b19-a428-3dde232114c6", "id": "28fefbe1-4ae0-8558-e063-6394a90ad25a", "effective_time": "20241211", "version": "6", "openfda": { "application_number": [ "M001" ], "brand_name": [ "Mylanta Maximum Strength Classic Flavor" ], "generic_name": [ "ANTACID AND ANTI GAS ALUMINUM HYDROXIDE MAGNESIUM HYDROXIDE AND SIMETHICONE" ], "manufacturer_name": [ "Infirst Healthcare Inc." ], "product_ndc": [ "62372-500" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ALUMINUM HYDROXIDE", "MAGNESIUM HYDROXIDE", "DIMETHICONE" ], "rxcui": [ "237870" ], "spl_id": [ "28fefbe1-4ae0-8558-e063-6394a90ad25a" ], "spl_set_id": [ "56853b20-a2aa-4b19-a428-3dde232114c6" ], "package_ndc": [ "62372-500-12", "62372-500-10", "62372-500-30" ], "is_original_packager": [ true ], "nui": [ "N0000010282" ], "pharm_class_pe": [ "Skin Barrier Activity [PE]" ], "unii": [ "5QB0T2IUN0", "NBZ3QY004S", "92RU3N3Y1O" ] } } ] }