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 10 mL 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
• pressure and bloating commonly referred to as gas
• acid indigestion
• sour stomach
• upset stomach due to these symptoms
• 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) 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:

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

WORKS ON CONTACT!

•  
  •  
    •  
      •  
        • Tough on Heartburn
        • Gentle on Your Body

SMOOTH CREAMY TASTE

Classic Flavor

12 FL OZ (355mL)

Also try Mylanta Maximum Strength Vanilla Caramel Flavor

and

Mylanta Tonight, with its soothing taste of Honey-Chamomile, is perfect for heartburn relief after dinner

and

Mylanta GasMinis ̶ great- tasting mini- tablets that relieve gas symptoms fast

The coating, acid-neutralizing power of Maximum Strength Mylanta® starts to work on contact.

It helps soothe and relieve heartburn, acid indigestion, and bothersome gas symptoms so you can feel better fast.

Tough on heartburn and gas, Mylanta works at the source of symptoms. It is gentle on your body with a great-tasting flavor, and can be used as directed every day.

• Multi-symptom relief
• Extra coating power
• Paraben- free

Active ingredients: Aluminum hydroxide, Magnesium hydroxide, Simethicone

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

©2017 Infirst Healthcare Inc.

Mylanta.com

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 FORM (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: 62372-500-12	355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/10/2016

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)