INON

Dosage form: granule
Ingredients: ALUMINUM HYDROXIDE 400mg in 1.92g, MAGNESIUM CARBONATE 400mg in 1.92g, SODIUM BICARBONATE 700mg in 1.92g
Labeler: Sato Pharmaceutical Co., Ltd.
NDC Code: 49873-045

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 packet (1.92g)]
Aluminum hydroxide 400 mg
Magnesium carbonate 400 mg
Sodium bicarbonate 700 mg

Purpose
Aluminum hydroxide     Antacid
Magnesium carbonate     Antacid
Sodium bicarbonate     Antacid

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

Warnings

Ask a doctor before use if you have
■ a sodium-restricted diet

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 3 packets 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 doctor
■ May have laxative effect

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

Keep out of reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away.

Directions
■ Adults and children 12 years of age and over: Take 1 packet at a time 3 times daily between meals or after meals, or as directed by a doctor
■ Children under 12 years: Ask a doctor

Other information ■ Each packet contains: sodium 175 mg, magnesium 95 mg

Inactive ingredients  colloidal silicon dioxide, flavor, partially hydrolyzed polyvinyl alcohol, sugar, starch

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INON 
aluminum hydroxide, magnesium carbonate, sodium bicarbonate granule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49873-045
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALUMINUM HYDROXIDE (ALUMINUM HYDROXIDE) ALUMINUM HYDROXIDE400 mg  in 1.92 g
MAGNESIUM CARBONATE (carbonate ion) MAGNESIUM CARBONATE400 mg  in 1.92 g
SODIUM BICARBONATE (bicarbonate ion) SODIUM BICARBONATE700 mg  in 1.92 g
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
POLYVINYL ALCOHOL 
SUCROSE 
STARCH, POTATO 
Product Characteristics
Color    Score    
ShapeSize
FlavorPEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:49873-045-0112 PACKET (PACKET) in 1 CARTON
11.92 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33105/31/1989
Labeler - Sato Pharmaceutical Co., Ltd. (690575642)
Establishment
NameAddressID/FEIOperations
Sato Pharmaceutical Co., Ltd.715699133manufacture, label, pack

Revised: 03/2012
 
Sato Pharmaceutical Co., Ltd.

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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