Your browser does not support JavaScript! INON ACE (MAGNESIUM ALUMINOSILICATE, MAGNESIUM HYDROXIDE) SOLUTION [SATO PHARMACEUTICAL CO., LTD.]
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INON ACE (magnesium aluminosilicate, magnesium hydroxide) solution
[Sato Pharmaceutical Co., Ltd.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:49873-403
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SILODRATE (SILODRATE) SILODRATE900 mg  in 30 mL
MAGNESIUM HYDROXIDE (MAGNESIUM CATION) MAGNESIUM HYDROXIDE250 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
BUTYLPARABEN 
CITRIC ACID MONOHYDRATE 
HYDROXYPROPYL CORN STARCH (5% SUBSTITUTION BY WEIGHT) 
POLYOXYL 60 HYDROGENATED CASTOR OIL 
PROPYLPARABEN 
SODIUM BENZOATE 
SODIUM CITRATE 
SORBITOL 
WATER 
Product Characteristics
Color    Score    
ShapeSize
FlavorCINNAMON (CINNAMON OIL) , MINT (MENTHA OIL) , GINGER (GINGER, LIQUID EXTRACT) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49873-403-012 in 1 CARTON
130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33105/20/2000
Labeler - Sato Pharmaceutical Co., Ltd. (690575642)
Establishment
NameAddressID/FEIBusiness Operations
Sato Pharmaceutical Co., Ltd.715699133manufacture(49873-403), label(49873-403), pack(49873-403)

Revised: 3/2013
 
Sato Pharmaceutical Co., Ltd.

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