INON ACE- silodrate and magnesium hydroxide solution 
Sato Pharmaceutical Co., Ltd.

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 bottle)
Magnesium Aluminosilicate 900 mg
Magnesium Hydroxide 250 mg

Purpose
Magnesium Aluminosilicate     Antacid
Magnesium Hydroxide     Antacid

Uses relieves these symptoms:
■ heartburn    ■ sour stomach    ■ acid indigestion

Warnings

Do not use this product if you are taking a prescription antibiotic drug containing any
form of tetracycline.

Ask a doctor or pharmacist before use if you are presently taking a prescription drug.
Antacids may interact with certain prescription drugs.

When using this product
■ Do not take more than 2 bottles (adults and children 12 years and over) in a 24-hours
    period or use the maximum dosage of this product for more than 2 weeks, except under
    the advice and supervision of a physician.
■ May have laxative effect.

Keep out of reach of children.

Directions
■ Adults and children 12 years and over: Take 1 bottle (30mL) at a time 2 times daily,    
    between meals, or as directed by a doctor.
■ Children under 12 years: Ask a doctor.
■ Shake well before use.

Other information
■ Each bottle contains: sodium 15 mg, magnesium 165 mg

Inactive ingredients  alcohol, butylparaben, citric acid, flavors (cinnamon oil, fluid
extract of ginger root, spearmint oil), hydroxypropylstarch, PEG-60 hydrogenated castor
oil, propylparaben, sodium benzoate, sodium citrate, sorbitol, water.

PDP

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Carton

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INON ACE 
magnesium aluminosilicate, magnesium hydroxide solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49873-403
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SILODRATE (UNII: 9T3UU8T0QK) (SILODRATE - UNII:9T3UU8T0QK) SILODRATE 900 mg  in 30 mL
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM HYDROXIDE 250 mg  in 30 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL (UNII: 3K9958V90M)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
HYDROXYPROPYL CORN STARCH (5% SUBSTITUTION BY WEIGHT) (UNII: 9M44R3409A)  
POLYOXYL 60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Color      Score     
Shape Size
Flavor CINNAMON (CINNAMON OIL) , MINT (MENTHA OIL) , GINGER (GINGER, LIQUID EXTRACT) Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49873-403-01 2 in 1 CARTON
1 30 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part331 05/20/2000
Labeler - Sato Pharmaceutical Co., Ltd. (690575642)
Establishment
Name Address ID/FEI Business Operations
Sato Pharmaceutical Co., Ltd. 715699133 manufacture(49873-403) , label(49873-403) , pack(49873-403)

Revised: 3/2013
Document Id: e9fd320a-7ceb-4095-9437-e68e9e6a914e
Set id: a6e4475c-dfac-493c-b98a-21473e3b59d5
Version: 2
Effective Time: 20130319
 
Sato Pharmaceutical Co., Ltd.