MAXIMUM STRENGTH ANTACID MINT- aluminum hydroxide, magnesium hydroxide, simethicone liquid

Maximum Strength Antacid Mint by

Drug Labeling and Warnings

Maximum Strength Antacid Mint by is a Otc medication manufactured, distributed, or labeled by Topco Associates, LLC, Guardian Drug Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS (in each 10 mL )

Aluminum hydroxide (equiv. to dried gel, USP) 800 mg
Magnesium hydroxide 800 mg
Simethicone 80 mg

PURPOSE

Antacid
Antacid
Antigas

USE(S)

relieves:

• acid indigestion
• heartburn
• sour stomach
• upset stomach and gas associated with these symptoms 

WARNINGS

Do not take more than 60 mL in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor.

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.

STOP USE AND ASK DOCTOR

if symptoms last more than two weeks

KEEP OUT OF REACH OF CHILDREN

.

DIRECTIONS

• shake well before use
• adults and children 12 years and older: take 10 mL to 20 mL two times a day, or as directed by a doctor
• children under 12 years: consult a doctor
• mL = milliliter

OTHER INFORMATION

• each 10 mL contains: magnesium 340 mg, sodium 5 mg
• store at controlled room temperature 20ºC-25ºC (68º-77ºF)
• do not freeze

INACTIVE INGREDIENTS

ethyl alcohol, flavor, glycerin, hydroxyethyl cellulose, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, simethicone emulsion, sorbitol

PRINCIPAL DISPLAY PANEL

Topcare Health

COMPARE TO MYLANTA® MAXIMUM STRENTH ACTIVE INGREDIENTS*

NDC: 36800-342-40

MAXIMUM STRENGTH

Antacid

Advanced

ANTACID & ANTIGAS

FAST RELIEF

• Heartburn
• Acid Indigestion
• Pressure
• Bloating (Gas)

 

ALCOHOL 0.2% v/v

MINT FLAVOR
12 FL OZ (355 mL)

INGREDIENTS AND APPEARANCE

MAXIMUM STRENGTH ANTACID MINT 
aluminum hydroxide, magnesium hydroxide, simethicone liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-342
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
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-342-40	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M001	09/01/2020

Labeler - Topco Associates, LLC (006935977)

Establishment
Name	Address	ID/FEI	Business Operations
Guardian Drug Company		119210276	MANUFACTURE(36800-342)