MAALOX ADVANCED REGULAR STRENGTH MINT- aluminum hydroxide, magnesium hydroxide, simethicone liquid 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

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 (in each 5 mL = 1 teaspoonful)

Aluminum hydroxide (equiv. to dried gel, USP) 200 mg
Magnesium hydroxide 200 mg
Simethicone 20 mg

Purpose

Antacid
Antacid
Antigas

Uses

for the relief of

acid indigestion
heartburn
sour stomach
upset stomach associated with these symptoms
pressure and bloating commonly referred to as gas

Warnings

do not take more than 16 teaspoonsful in a 24-hour period or use the maximum dosage for more than 2 weeks except under the advice and supervision of a physician.

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 more than 2 weeks.

Keep out of reach of children.

Directions

shake well before using
adults and children 12 years and older: take 2 to 4 teaspoonsful four times a day or as directed by a physician
do not take more than 16 teaspoonsful in 24 hours or use the maximum dosage for more than 2 weeks
children under 12 years: consult a physician

Other information

each teaspoonful contains: magnesium 75 mg, potassium 5 mg
store at controlled room temperature 20-25°C(68-77°F)
protect from freezing

Inactive ingredients

butylparaben, carboxymethylcellulose sodium, flavor, glycerin, hypromellose, microcrystalline cellulose, propylene glycol, propylparaben, purified water, saccharin sodium, sorbitol

Questions or comments?

call 1-800-452-0051 24 hours a day, 7 days a week.

Principal Display Panel

0067-6281-44

Maalox
Advanced
Regular Strength
Antacid & Antigas

FAST RELIEF
HEARTBURN & ACID INDIGESTION
PRESSURE & BLOATING

Mint
Flavored Liquid

770 mL (26 FL OZ)

Maalox Advanced RS Mint Liquid 26 oz bottle label
MAALOX  ADVANCED REGULAR STRENGTH MINT
aluminum hydroxide, magnesium hydroxide, simethicone liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-6281
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE200 mg  in 5 mL
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE200 mg  in 5 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE20 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorWHITE (opaque) Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0067-6281-62148 mL in 1 BOTTLE; Type 0: Not a Combination Product04/04/200812/31/2017
2NDC:0067-6281-71355 mL in 1 BOTTLE; Type 0: Not a Combination Product04/04/200812/31/2017
3NDC:0067-6281-44770 mL in 1 BOTTLE; Type 0: Not a Combination Product04/04/200812/31/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33204/04/200812/31/2017
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 2/2018
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC