ANTACID REGULAR STRENGTH- 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) 200 mg

Magnesium hydroxide 200 mg

Simethicone 20 mg

Purpose

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 24 teaspoonfuls (120 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 85 mg
•
does not meet USP requirements for preservative effectiveness
•
store at 20º-25ºC (68º-77ºF).

Inactive ingredients

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

Principal Display Panel

Regular Strength

ANTACID

Antacid/Anti-Gas

Fast Acting

Classic Flavor

Original Flavor

Soothing Relief of

HEARTBURN

ACID INDIGESTION

SOUR STOMACH

ALCOHOL 0.2%

COMPARE TO MYLANTA® Active Ingredients

Gluten Free

Antacid Front Label Image
Antacid Back Label Image
ANTACID  REGULAR STRENGTH
aluminum hydroxide, magnesium hydroxide, simethicone liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55312-357
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 (UNII: K679OBS311)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorWHITE (opaque) Score    
ShapeSize
FlavorMINT, LEMONImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55312-357-40355 mL in 1 BOTTLE; Type 0: Not a Combination Product01/15/200907/10/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33207/15/199007/10/2017
Labeler - Western Family Foods Inc (192166072)

Revised: 8/2017
Document Id: ef785b05-81f5-4601-b0fe-1c589a60b511
Set id: 2b96f24a-1da6-4a82-ae41-000be3ed5ebc
Version: 5
Effective Time: 20170825
 
Western Family Foods Inc