ANTACID MINT- aluminum hydroxide, magnesium hydroxide and dimethicone suspension
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Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active Ingredients

Aluminum hydroxide (equivalent to Dried Gel, USP) 200 mg
Magnesium hydroxide 200 mg
Simethicone 20 mg

Purpose

Uses

relieves: • heartburn • sour stomach
• acid indigestion • upset stomach due to these symptoms
• symptoms of gas

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 a doctor if

symptoms last for more than 2 weeks

If pregnant or breast-feeding

ask a health professional before use.

Keep this and all drugs out of the reach of children.

In case of accidental overdose, seek professional assistance
or contact a Poison Control Center immediately.

Directions

• shake well before use
• do not exceed 24 teaspoons (120 mL) in a 24 hour period or
use the maximum dosage for more than 2 weeks
• adults and children 12 years of age and older: take 2 to 4
teaspoons (10-20 mL) between meals and at
bedtime or as directed by a doctor
• children under 12 years of age: ask a doctor

Warnings

Other Information

• do not freeze
• store at room temperature tightly closed
• each teaspoon contains:
potassium 2 mg, magnesium 83 mg

Inactive Ingredients

benzyl alcohol, flavors, glycerin, hydroxyethyl cellulose,
potassium citrate, propylene glycol, purified water, sorbitol, saccharin sodium

Principal Display Panel

ANTACID MINT
aluminum hydroxide, magnesium hydroxide and dimethicone suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:15127-540
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
BENZYL ALCOHOL (UNII: LKG8494WBH)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SACCHARIN SODIUM ANHYDROUS (UNII: I4807BK602)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT (mint flavor)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:15127-540-73	355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/03/2009	10/01/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part331	06/03/2009	10/01/2017

Labeler - Select Brand Dist. (012578514)

Revised: 10/2017

Document Id: 4631229a-2b8d-4d4e-8e73-097403694fec

Set id: 7d393d81-20c7-4cc5-9d63-859ac2319d0e

Version: 3

Effective Time: 20171030

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