Drug Facts

Drug Facts

SPL v3

SPL

SPL Set ID ed1b03f0-fabc-4c1c-8e6d-9f15c380300c

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 Fd&c Red No. 40 Magnesium Stearate Maltodextrin Sucralose

Identifiers & Packaging

Pill Appearance

Imprint: M1Y Shape: round Color: pink 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, FD&C Red #40 Lake, 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

BERRY

GINGER

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, FD&C Red #40 Lake, 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

BERRY

GINGER

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": "FD&C RED NO. 40", "unii": "WZB9127XOA", "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, FD&C Red #40 Lake, 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 BERRY GINGER"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:02:32.788768 · Updated: 2026-03-14T23:02:10.811423