MYLANTA CLASSIC- calcium carbonate, magnesium hydroxide, simethicone liquid

Mylanta Classic by

Drug Labeling and Warnings

Mylanta Classic by is a Otc medication manufactured, distributed, or labeled by Infirst Healthcare Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Calcium carbonate 800 mg

Magnesium hydroxide 270 mg

Simethicone 80 mg

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 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.

Directions

shake well before use measure with dosing cup provided

adults and children 12 years and over:

10 mL-20 mL (1-2 doses) as needed, 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

Other information

each 10 mL dose contains:

calcium 335 mg; magnesium 120 mg; sodium 8 mg

store between 20-25°C (68-77°F), do not freeze

Inactive ingredients

benzoic acid, benzyl alcohol, edetate disodium, flavors, glycerin, glyceryl monostearate, methylcellulose, microcrystalline cellulose, peg-8 stearate, polysorbate 65, purified water, sodium benzoate, sorbic acid, sucralose, xanthan gum

Questions or comments?

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

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING.

infirst +

HEALTHCARE®

Manufactured for:

Infirst Healthcare Inc.

Westport, CT 06880

©2023 Infirst Healthcare Inc.

Mylanta.com

Lot:

Exp:

PRINCIPAL DISPLAY PANEL

Mylanta ®

LIQUID ANTACID+ANTI-GAS

WORKS ON CONTACT!

Fast relief of heartburn, acid indigestion, and painful gas.

CLASSIC FLAVOR

12 FL OZ (355 mL)

INGREDIENTS AND APPEARANCE

MYLANTA CLASSIC 
calcium carbonate, magnesium hydroxide, simethicone liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62372-501
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	800 mg  in 10 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	80 mg  in 10 mL
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM HYDROXIDE	270 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
BENZOIC ACID (UNII: 8SKN0B0MIM)
BENZYL ALCOHOL (UNII: LKG8494WBH)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
METHYLCELLULOSE, UNSPECIFIED (UNII: Z944H5SN0H)
PEG-8 STEARATE (UNII: 2P9L47VI5E)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBIC ACID (UNII: X045WJ989B)
SUCRALOSE (UNII: 96K6UQ3ZD4)
POLYSORBATE 65 (UNII: 14BGY2Y3MJ)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	white	Score
Shape		Size
Flavor	LEMON (Mint)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62372-501-12	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/31/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M001	01/31/2024

Labeler - Infirst Healthcare Inc. (079159739)