ANTACID- aluminum hydroxide, magnesium hydroxide, simethicone liquid 
Western Family Foods Inc

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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Western Family Antacid Drug Facts

Active ingredient (in each 5 mL teaspoon)

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

Magnesium hydroxide 400 mg

Simethicone 40 mg

Purposes

Antacid

Antigas

Uses

relieves

•
heartburn
•
acid indigestion
•
sour stomach
•
upset stomach due to these symptoms
•
pressure and bloating commonly 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

now taking a prescription drug. Antacids may interact with certain prescription drugs.

When using this product

do not exceed 12 teaspoonfuls (60 mL) in a 24-hour period, or use the maximum dosage for more than 2 weeks, unless directed by a doctor

Keep out of reach of children.

Directions

•
shake well
•
adults and children 12 years and older: take 2-4 teaspoonfuls (10-20 mL) between meals, at bedtime, or as directed by a doctor
•
children under 12 years: ask a doctor

Other information

•
each teaspoon contains: magnesium 175 mg, potassium 10 mg and sodium 2 mg
•
doesnot meet USP requirements for preservative effectiveness
•
store at 20º-25ºC (68º-77ºF)

Inactive ingredients

butylparaben, flavor, hypromellose, microcrystalline cellulose and carboxymethylcellulose sodium, potassium citrate, propylparaben, purified water, simethicone emulsion, sorbitol, sorbitol solution

Principal Display Panel

Maximum Strength

ANTACID

Antacid/Anti-Gas

Fast Acting

Classic Flavor

Original Flavor

Soothing Relief of

HEARTBURN

ACID INDIGESTION

SOUR STOMACH

COMPARE TO MYLANTA® Active Ingredients

Gluten Free

Antacid Front Label
Antacid Back Label
ANTACID 
aluminum hydroxide, magnesium hydroxide, simethicone liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55312-340
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POTASSIUM CITRATE (UNII: EE90ONI6FF)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorWHITE (opaque) Score    
ShapeSize
FlavorLEMONImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55312-340-40355 mL in 1 BOTTLE; Type 0: Not a Combination Product10/18/199510/15/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33110/18/199510/15/2017
Labeler - Western Family Foods Inc (192166072)

Revised: 11/2017
Document Id: 36f5db0c-661a-4828-9b95-6b68405b7dc2
Set id: 013bd74a-3420-4cd4-8546-83d11cae7739
Version: 2
Effective Time: 20171127
 
Western Family Foods Inc