MYLANTA MAXIMUM STRENGTH CLASSIC FLAVOR- antacid and anti gas aluminum hydroxide magnesium hydroxide and simethicone suspension 
Infirst Healthcare Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Mylanta Maximum Strength Classic Flavor 3.4 FL OZ

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

Mylanta Maximum Strength Classic Flavor 3.4 FL OZ
MYLANTA MAXIMUM STRENGTH CLASSIC FLAVOR 
antacid and anti gas aluminum hydroxide magnesium hydroxide and simethicone suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62372-500
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE800 mg  in 10 mL
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM HYDROXIDE800 mg  in 10 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE80 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITE (OFF WHITE) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62372-500-10100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33111/10/2016
Labeler - Infirst Healthcare Inc. (079159739)

Revised: 2/2023
Document Id: 23cf43f1-13d1-40e8-a0e4-213b2ab15bd3
Set id: 23cf43f1-13d1-40e8-a0e4-213b2ab15bd3
Version: 1
Effective Time: 20230201
 
Infirst Healthcare Inc.