Drug Facts

Drug Facts

SPL v3

SPL

SPL Set ID aa694e0d-7891-4870-8106-dd57f1e29fb4

Route

ORAL

Published

Effective Date 2021-08-24

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Carbonate Ion (1000 mg) Hydroxide Ion (270 mg) Dimethicone (80 mg)

Inactive Ingredients

Adipic Acid Crospovidone Dextrose, Unspecified Form Magnesium Stearate Maltodextrin Sucralose

Identifiers & Packaging

Pill Appearance

Imprint: M1Y Shape: round Color: white Size: 20 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Completed Since 2021-05-04 Until 2025-02-28

Description

Calcium carbonate 1000mg Magnesium hydroxide 270mg Simethicone 80mg

Purpose

Antacid Antacid Anti-gas

Medication Information

Purpose

Antacid Antacid Anti-gas

Description

Calcium carbonate 1000mg Magnesium hydroxide 270mg Simethicone 80mg

Uses

relieves:

heartburn
acid indigestion
sour stomach
upset stomach due to these symptoms
pressure and bloating commonly referred to as gas
overindulgence in food and drink

Section 42229-5

Fast, powerful multi-symptom relief in a great-tasting ONE tablet dose.

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.

^©2021 Infirst Healthcare Inc.

Mylanta.com

Purposes

Antacid

Anti-gas

Warnings

Ask a doctor before use if you have

kidney disease
a magnesium restricted diet

Ask a doctor or pharmacist before use if you arepresently taking a prescription drug. Antacids may interact with certain prescription drugs.

Directions

adults and children 12 years and over:chew 1 tablet as symptoms occur, or as directed by doctor
do not take more than 6 tablets in 24 hours
do not use the maximum dosage for more than 2 weeks
children under 12 years of age:ask a doctor

Questions?

call 1-844-695-6624toll free (English and Spanish)

Other Information

each chewable tablet contains:calcium 400mg, magnesium 115mg
store between 20-25°C (68-77°F)

Inactive Ingredients

adipic acid, crospovidone, dextrose, flavors, magnesium stearate, maltodextrin, sucralose

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.

Active Ingredients (in Each Tablet)

Calcium carbonate 1000mg

Magnesium hydroxide 270mg

Simethicone 80mg

Package/label Principal Display Panel

NEW!

3 POWERFUL INGREDIENTS IN ONE

Mylanta ^®

ONE ^TM

ANTACID + ANTI-GAS

WORKS IN ONE TABLET

WITH A SMOOTH SOOTHING TASTE!

50 SINGLE DOSE CHEWABLE TABLETS

LEMON

MINT

Structured Label Content

Uses

relieves:

heartburn
acid indigestion
sour stomach
upset stomach due to these symptoms
pressure and bloating commonly referred to as gas
overindulgence in food and drink

Section 42229-5 (42229-5)

Fast, powerful multi-symptom relief in a great-tasting ONE tablet dose.

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.

^©2021 Infirst Healthcare Inc.

Mylanta.com

Purposes

Antacid

Anti-gas

Warnings

Ask a doctor before use if you have

kidney disease
a magnesium restricted diet

Ask a doctor or pharmacist before use if you arepresently taking a prescription drug. Antacids may interact with certain prescription drugs.

Directions

adults and children 12 years and over:chew 1 tablet as symptoms occur, or as directed by doctor
do not take more than 6 tablets in 24 hours
do not use the maximum dosage for more than 2 weeks
children under 12 years of age:ask a doctor

Questions?

call 1-844-695-6624toll free (English and Spanish)

Other Information (Other information)

each chewable tablet contains:calcium 400mg, magnesium 115mg
store between 20-25°C (68-77°F)

Inactive Ingredients (Inactive ingredients)

adipic acid, crospovidone, dextrose, flavors, magnesium stearate, maltodextrin, sucralose

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.

Active Ingredients (in Each Tablet) (Active ingredients (in each tablet))

Calcium carbonate 1000mg

Magnesium hydroxide 270mg

Simethicone 80mg

Package/label Principal Display Panel (Package/Label Principal Display Panel)

NEW!

3 POWERFUL INGREDIENTS IN ONE

Mylanta ^®

ONE ^TM

ANTACID + ANTI-GAS

WORKS IN ONE TABLET

WITH A SMOOTH SOOTHING TASTE!

50 SINGLE DOSE CHEWABLE TABLETS

LEMON

MINT

Advanced Ingredient Data

[{"name": "ADIPIC ACID", "unii": "76A0JE0FKJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CROSPOVIDONE", "unii": "2S7830E561", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DEXTROSE, UNSPECIFIED FORM", "unii": "IY9XDZ35W2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MALTODEXTRIN", "unii": "7CVR7L4A2D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBONATE ION", "unii": "7UJQ5OPE7D", "classCode": "ACTIB", "strengthNumerator": "1000", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "HYDROXIDE ION", "unii": "9159UV381P", "classCode": "ACTIB", "strengthNumerator": "270", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "DIMETHICONE", "unii": "92RU3N3Y1O", "classCode": "ACTIB", "strengthNumerator": "80", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Uses": "relieves: heartburn acid indigestion sour stomach upset stomach due to these symptoms pressure and bloating commonly referred to as gas overindulgence in food and drink", "42229-5": "Fast, powerful multi-symptom relief in a great-tasting ONE tablet dose. 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. © 2021 Infirst Healthcare Inc. Mylanta.com", "Purposes": "Antacid Antacid Anti-gas", "Warnings": "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.", "Directions": "adults and children 12 years and over: chew 1 tablet as symptoms occur, or as directed by doctor do not take more than 6 tablets in 24 hours do not use the maximum dosage for more than 2 weeks children under 12 years of age: ask a doctor", "Questions?": "call 1-844-695-6624 toll free (English and Spanish)", "Other information": "each chewable tablet contains: calcium 400mg, magnesium 115mg store between 20-25°C (68-77°F)", "Inactive ingredients": "adipic acid, crospovidone, dextrose, flavors, magnesium stearate, maltodextrin, sucralose", "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.", "Active ingredients (in each tablet)": "Calcium carbonate 1000mg Magnesium hydroxide 270mg Simethicone 80mg", "Package/Label Principal Display Panel": "NEW! 3 POWERFUL INGREDIENTS IN ONE Mylanta ® ONE TM ANTACID + ANTI-GAS WORKS IN ONE TABLET WITH A SMOOTH SOOTHING TASTE! 50 SINGLE DOSE CHEWABLE TABLETS LEMON MINT"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:32.753484 · Updated: 2026-03-14T23:02:09.430554