ANTACID- aluminum hydroxide, magnesium hydroxide and simethicone suspension 
Safeway

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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Maximum Strength Antacid Liquid

Active ingredient (in each 5mL tsp.)

Aluminum hydroxide (equvi. to dried gel, USP) 400 mg

Magnesium hydroxide 400 mg

Simethicone 40 mg

Purpose

Antacid

Antacid

Antigas

Uses

Warnings

Do not take more than 8 teaspoonfuls 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 a doctor

if symptoms last more than two weeks

Keep out of reach of children.

Directions

Other information

Inactive ingredients

flavor, glycerin, hydroxyethylcellulose, methylparaben, propylene glycol, purified water, saccharin sodium, simethicone emulsion, sorbitol

PDP

Compare to Maalox maximum strength liquid cherry active ingredients

Maximum strength

Antacid Liquid

Aluminum Hydroxide 400 mg - Antacid

Magnesium Hydroxide 400 mg - Antacid

Simethicone 40 mg - Antigas

LBL

ANTACID 
aluminum hydroxide, magnesium hydroxide and simethicone suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-508
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE400 mg  in 5 mL
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM HYDROXIDE400 mg  in 5 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE40 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21130-508-05177 mL in 1 BOTTLE; Type 0: Not a Combination Product12/12/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33212/12/2015
Labeler - Safeway (009137209)
Establishment
NameAddressID/FEIBusiness Operations
Guardian Drug Company119210276manufacture(21130-508)

Revised: 1/2016
Document Id: ac703a32-8e0f-4dd4-b7b8-5fba72b7cd59
Set id: d36b56a4-06f0-47ff-8add-4c327d60be22
Version: 1
Effective Time: 20160121
 
Safeway