MYLANTA ONE ANTACID/ANTI-GAS- calcium carbonate, magnesium hydroxide, dimethicone tablet, chewable

Mylanta One Antacid/Anti-Gas by

Drug Labeling and Warnings

Mylanta One Antacid/Anti-Gas by is a Otc medication manufactured, distributed, or labeled by Infirst Healthcare Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each tablet)

Calcium carbonate 1000mg

Magnesium hydroxide 270mg

Simethicone 80mg

Purposes

Antacid

Antacid

Anti-gas

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

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.

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.

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

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

Questions?

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

SPL UNCLASSIFIED SECTION

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

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

Package/Label Principal Display Panel

3 POWERFUL INGREDIENTS IN ONE

Mylanta ®
ONE

ANTACID + ANTI-GAS

WORKS IN ONE TABLET

WITH A SMOOTH SOOTHING TASTE!

50 SINGLE DOSE CHEWABLE TABLETS

BERRY
GINGER

INGREDIENTS AND APPEARANCE

MYLANTA ONE ANTACID/ANTI-GAS 
calcium carbonate, magnesium hydroxide, dimethicone tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62372-552
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D)	CALCIUM CARBONATE	1000 mg
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P)	MAGNESIUM HYDROXIDE	270 mg
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	80 mg

Inactive Ingredients
Ingredient Name	Strength
ADIPIC ACID (UNII: 76A0JE0FKJ)
CROSPOVIDONE (UNII: 2S7830E561)
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	pink	Score	no score
Shape	ROUND	Size	20mm
Flavor	BERRY, GINGER	Imprint Code	M1Y
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62372-552-50	50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/04/2021	02/28/2025
2	NDC: 62372-552-51	50 in 1 BOTTLE; Type 0: Not a Combination Product	08/16/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M001	05/04/2021

Labeler - Infirst Healthcare Inc. (079159739)