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Inon Ace by Sato Pharmaceutical Co., Ltd.

Dosage form: tablet
Ingredients: magnesium hydroxide 60mg, SILODRATE 200mg, SIMETHICONE 20mg
Labeler: Sato Pharmaceutical Co., Ltd.
NDC Code: 49873-402

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.

DRUG FACTS

Active ingredients (in each tablet)
Magnesium Aluminosilicate 200 mg
Magnesium Hydroxide 60 mg
Simethicone 20 mg

Purposes
Magnesium Aluminosilicates    Antacid
Magnesium Hydroxide    Antacid
Simethicone    Antigas

Uses relieves these symptoms
■heartburn ■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.
  • may have a laxative effect 

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

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
magnesium hydroxide (magnesium cation) magnesium hydroxide60 mg
SILODRATE (silodrate) SILODRATE200 mg
SIMETHICONE (SIMETHICONE) SIMETHICONE20 mg
Inactive Ingredients
Ingredient NameStrength
caramel 
silicon dioxide 
croscarmellose sodium 
HYDROXYPROPYL CELLULOSE (TYPE H) 
magnesium stearate 
cellulose, microcrystalline 
ferric oxide yellow 
Product Characteristics
Colorbrown (pale brown) Scoreno score
ShapeROUNDSize9mm
FlavorPEPPERMINT, GINGER (ginger extract) , CINNAMON (cinnamon oil) , ANISE (fennel) Imprint CodeSATO;6
Contains    
Packaging
#Item CodePackage Description
1NDC:49873-402-011 BOTTLE in 1 CARTON
175 TABLET 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/FEIOperations
Sato Pharmaceutical Co., Ltd.715699133manufacture(49873-402), label(49873-402), pack(49873-402)

Revised: 11/2015
 
Sato Pharmaceutical Co., Ltd.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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