MYLANTA MAXIMUM STRENGTH CLASSIC FLAVOR- antacid and anti gas aluminum hydroxide magnesium hydroxide and simethicone suspension

Mylanta Maximum Strength Classic Flavor by

Drug Labeling and Warnings

Mylanta Maximum Strength Classic Flavor 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 2 tsp dose)

Aluminum hydroxide
(equivalent to dried gel, USP) 800 mg

Magnesium hydroxide 800 mg

Simethicone 80 mg

Purpose

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
• 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

• each 2 tsp dose contains: magnesium 340 mg; sodium 7 mg
• store between 20-25°C (68-77°F), do not freeze

Inactive ingredients

benzyl alcohol, carboxymethylcellulose sodium, flavors, glycerin, microcrystalline cellulose, purified water, sodium carbonate, sorbitol, sucralose, xanthan gum

Questions or comment?

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

Principal Display Panel

MYLANTA®
ANTACID
+
ANTI-GAS
Alcohol 0.2%

MAXIMUM STRENGTH

FAST HEARTBURN & GAS RELIEF ON THE GO!

SMOOTH CREAMY TASTE

CLASSIC
FLAVOUR

3.4 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

INGREDIENTS AND APPEARANCE

MYLANTA MAXIMUM STRENGTH CLASSIC FLAVOR 
antacid and anti gas aluminum hydroxide magnesium hydroxide and simethicone suspension

Product 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)