INON ACE - almasilate, magnesium hydroxide and dimethicone tablet 
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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Active ingredients (in each tablet)
Magnesium Aluminosilicates 200 mg
Magnesium Hydroxide 60 mg
Simethicone 20 mg

Purposes
Magnesium Aluminosilicates    Antacid
Magnesium Hydroxide    Antacid
Simethicone    Antigas

Uses relieves these symptoms
■hartburn ■acid indigestion ■sour stomach
■upset stomach and gas associated with these symptoms

Enter section text here

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

When using this product
■Do not take more than 9 tablets in 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.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Directions
■Adults and children 12 years of age and over: Take 3 tablets with water 3 times daily between meals and at bedtime, or as directed by a doctor.
■Children under 12 years: Ask a doctor.

Other information  
■Each tablet contains: sodium 8 mg, magnesium 35 mg
■Do not purchase if printed seal with “sato” is broken or missing from top or bottom of carton.

Inactive ingredients  caramel, colloidal silicon dioxide, croscarmellose sodium, flavor, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, synthetic iron oxide

inonacePDP.jpgPDP

inonacecart.jpgCarton

INON ACE 
magnesium aluminosilicates, magnesium hydroxide, simethicone tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49873-402
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
almasilate (almasilate) almasilate200 g
magnesium hydroxide (magnesium hydroxide) magnesium hydroxide60 mg
dimethicone (dimethicone) dimethicone20 mg
Inactive Ingredients
Ingredient NameStrength
caramel 
silicon dioxide 
croscarmellose sodium 
HYDROXYPROPYL CELLULOSE 
magnesium stearate 
cellulose, microcrystalline 
ferric oxide yellow 
Product Characteristics
Colorbrown (pale brown) Scoreno score
ShapeROUNDSize9mm
FlavorPEPPERMINT (cinnamon, fennel, ginger) Imprint Code SATO;6
Contains    
Packaging
#Item CodePackage Description
1NDC:49873-402-011 in 1 CARTON
175 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33111/01/1995
Labeler - Sato Pharmaceutical Co., Ltd. (690575642)
Establishment
NameAddressID/FEIBusiness Operations
Sato Pharmaceutical Co., Ltd.715699133manufacture, label, pack

Revised: 12/2011
Document Id: c5035904-5f81-422c-9f0a-93c5fc4ac762
Set id: 0af4355f-e160-409d-8471-2de98dbc6f7c
Version: 3
Effective Time: 20111228
 
Sato Pharmaceutical Co., Ltd.