ANTACID MINT- aluminum hydroxide, magnesium hydroxide, dimethicone suspension

ANTACID MINT by

Drug Labeling and Warnings

ANTACID MINT by is a Otc medication manufactured, distributed, or labeled by Chain Drug Marketing Association, GCP Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each 5 mL teaspoonful)

Aluminum hydroxide 200 mg (equivalent to dried gel, USP)

Magnesium hydroxide 200 mg

Simethicone 20mg

Purposes

Antacid

Antigas

Uses

relieves

• heartburn
• sour stomach
• acid indigestion
• the symptoms referred to as gas

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 taking a prescription drug.

Antacids may interact with certain prescription drugs.

Stop use and ask a doctor if symptoms last more than 2 weeks

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Directions

shake well before each use

adults and children 12 years and older: take 2 to 4 teaspoonfuls, as needed, up to four times a day, or as directed by a doctor

do not take more than 16 teaspoonfuls in 24 hours unless directed by a doctor or use the maximum dosage for more than 2 weeks

children under 12 years: ask a doctor

Other information

each 5 mL teaspoonful contains: magnesium 85 mg, sodium 3 mg

store at room temperature

protect from freezing

keep tightly closed

Inactive ingredients

benzyl alcohol, butylparaben, carboxymethylcellulose sodium, flavor, hypromellose, microcrystalline cellulose, propylparaben, purified water, saccharin sodium, sorbitol solution

package Label

INGREDIENTS AND APPEARANCE

ANTACID MINT 
aluminum hydroxide, magnesium hydroxide, dimethicone suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63868-694
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0)	ALUMINUM HYDROXIDE	200 mg  in 5 mL
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P)	MAGNESIUM HYDROXIDE	200 mg  in 5 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	20 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
HYPROMELLOSES (UNII: 3NXW29V3WO)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63868-694-57	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	03/01/2014

Labeler - Chain Drug Marketing Association (011920774)

Registrant - GCP Laboratories (965480861)

Establishment
Name	Address	ID/FEI	Business Operations
GCP Laboratories		965480861	manufacture(63868-694)