MYLANTA MAXIMUM STRENGTH CLASSIC FLAVOR ANTACID AND ANTI GAS- aluminum hydroxide, magnesium hydroxide, and dimethicone liquid

MYLANTA MAXIMUM STRENGTH CLASSIC FLAVOR antacid and anti gas by

Drug Labeling and Warnings

MYLANTA MAXIMUM STRENGTH CLASSIC FLAVOR antacid and anti gas by is a Otc medication manufactured, distributed, or labeled by Mechanical Servants LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each 10 mL dose)	Purposes
Aluminum hydroxide (equivalent to dried gel, USP), 800 mg	Antacid
Magnesium hydroxide, 800 mg	Antacid
Simethicone, 80 mg	Anti-gas

Use

relieves:

• heartburn
• acid indigestion
• sour stomach
• upset stomach due to these symptoms
• pressure and bloating commonly referred to as gas
• overindulgence in food & drink

Warnings

Ask a doctor before use if you have

• kidney disease or 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.

Directions

• adults and children 12 years and over: Take one 10 mL dose as needed 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

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 comments?

1-844-695-6624

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Repackaged and distributed by Convenience Valet®
Glendale Heights, IL 60139

PRINCIPAL DISPLAY PANEL - 10 mL Pouch Carton

Mylanta®

MAXIMUM
STRENGTH

STARTS
TO WORK
ON CONTACT!

• Tough on Heartburn
• Soothing Fast Relief

SMOOTH
CREAMY TASTE

Classic
Flavor

ANTACID
+
ANTI-GAS

Alcohol 0.2%

4 Single Dose
Pouches
0.3 FL OZ (10 mL)
Each

INGREDIENTS AND APPEARANCE

MYLANTA MAXIMUM STRENGTH CLASSIC FLAVOR ANTACID AND ANTI GAS 
aluminum hydroxide, magnesium hydroxide, and dimethicone liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 29485-8127
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 1 mL
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (HYDROXIDE ION - UNII:9159UV381P)	MAGNESIUM HYDROXIDE	800 mg  in 1 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	80 mg  in 1 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	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 29485-8127-4	4 in 1 CARTON	03/04/2019
1		10 mL in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part331	11/10/2016

Labeler - Mechanical Servants LLC (005530951)

Establishment
Name	Address	ID/FEI	Business Operations
Mechanical Servants LLC		005530951	REPACK(29485-8127) , RELABEL(29485-8127)