Label: MYLANTA MAXIMUM STRENGTH CLASSIC FLAVOR- antacid and anti gas aluminum hydroxide magnesium hydroxide and simethicone suspension
- NDC Code(s): 62372-500-10
- Packager: Infirst Healthcare Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated February 1, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (in each 2 tsp dose)
- Purpose
- Uses
- Warnings
- Ask a doctor or pharmacist before use if you are
- Keep out of reach of children.
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Directions
- •
- shake well before use
- •
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adults and children 12 years and over:
2 tsp – 4 tsp (1-2 doses) between meals, at bedtime or as directed by a doctor - •
- do not take more than 12 tsp (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
- •
- tsp = teaspoon
- Other information
- Inactive ingredients
- Questions or comment?
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Principal Display Panel
MYLANTA®
ANTACID
+
ANTI-GAS
Alcohol 0.2%MAXIMUM STRENGTH
FAST HEARTBURN & GAS RELIEF ON THE GO!
SMOOTH CREAMY TASTE
CLASSIC
FLAVOUR3.4 FL OZ (100 mL)
78034MYLLF
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
©2020 Infirst Healthcare Inc.Mylanta.com
Manufactured for:
Infirst Healthcare Inc.
Westport, CT 06880
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INGREDIENTS AND APPEARANCE
MYLANTA MAXIMUM STRENGTH CLASSIC FLAVOR
antacid and anti gas aluminum hydroxide magnesium hydroxide and simethicone suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62372-500 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE 800 mg in 10 mL MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM HYDROXIDE 800 mg in 10 mL DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 80 mg in 10 mL Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL (UNII: LKG8494WBH) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) GLYCERIN (UNII: PDC6A3C0OX) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) WATER (UNII: 059QF0KO0R) SODIUM CARBONATE (UNII: 45P3261C7T) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color WHITE (OFF WHITE) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62372-500-10 100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 11/10/2016 Labeler - Infirst Healthcare Inc. (079159739)