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

Regular Strength Antacid Mint by

Drug Labeling and Warnings

Regular 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) 400 mg
Magnesium hydroxide 400 mg
Simethicone 40 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 80 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 four 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 170 mg, sodium 5 mg
• store at 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
NDC: 36800-582-40

REGULAR STRENGTH

Antacid

Advanced

ANTACID & ANTIGAS

FAST RELIEF

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

 

ALCOHOL 0.4% v/v

12 FL OZ (355 mL)
MINT FLAVOR

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-582
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0)	ALUMINUM HYDROXIDE	400 mg  in 10 mL
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM HYDROXIDE	400 mg  in 10 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	40 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: 36800-582-40	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M001	10/01/2020

Labeler - Topco Associates, LLC (006935977)

Establishment
Name	Address	ID/FEI	Business Operations
Guardian Drug Company		119210276	MANUFACTURE(36800-582)