OHTAS ISAN ANTACID - magnesium aluminosilicate, calcium carbonate, sodium bicarbonate tablet 
OHTA'S ISAN 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 tablet)

Magnesium aluminometasilicate        83.3 mg 
Precipitated calcium carbonate         133.3 mg 
Sodium bicarbonate                         133.3 mg

Purpose

Magnesium aluminometasilicate ............ Antacid 
Precipitated calcium carbonate ............. Antacid
Sodium bicarbonate ............................. Antacid

Uses

relieves: ■ heartburn ■ acid indigestion ■ sour stomach ■ upset stomach due to these symptoms

Warnings

Do not use more than 9 tablets in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor.

Ask a doctor or pharmacist before use if you are

■ presently taking a prescription drug. Antacids may interact with certain prescription drugs
■ on a sodium-restricted diet

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Direction

swallow 3 tablets with a glass of water after meals, 3 times daily

Other Information

each tablet contains: sodium 36.7 mg. ■ keep the carton. It contains important information.
■ store at 20°-25°C (68°-77°F) ■ protect from moisture

Inactive ingredients

cinnamon bark, cinnamon oil, citrus unshiu peel, clove, fennel, fennel oil, gentian, lemon oil, menthol, magnesium stearate, microcrystalline cellulose, nutmeg, powdered picrasma wood.

PRINCIPAL DISPLAY PANEL

NDC 49631-212-01

Ohta's Isan ANTACID TABLETS

Heartburn   Acid Indigestion   Upset Stomach

45 TABLETS

Manufactured by
OHTA'S ISAN CO., LTD.
3-2, SENGOKU 2-CHOME, BUNKYO-KU,
TOKYO 112-0011, JAPAN

PRODUCT OF JAPAN

DO NOT USE IF A CARTON IS DAMAGED OR FOIL SEAL IS BROKEN.

Lot. No.

Exp. Date

45 Tablets Label
OHTAS ISAN ANTACID  
magnesium aluminosilicate, calcium carbonate, sodium bicarbonate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49631-212
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Almasilate (UNII: OZQ8O62H53) (Almasilate - UNII:OZQ8O62H53) Almasilate83.3 mg
Calcium Carbonate (UNII: H0G9379FGK) (Carbonate Ion - UNII:7UJQ5OPE7D) Calcium Carbonate133.3 mg
Sodium Bicarbonate (UNII: 8MDF5V39QO) (Bicarbonate Ion - UNII:HN1ZRA3Q20) Sodium Bicarbonate133.3 mg
Inactive Ingredients
Ingredient NameStrength
Cinnamon (UNII: 5S29HWU6QB)  
Cinnamon Oil (UNII: E5GY4I6YCZ)  
Tangerine (UNII: KH3E3096OO)  
Clove (UNII: K48IKT5321)  
Clove Oil (UNII: 578389D6D0)  
Fennel (UNII: 557II4LLC3)  
Fennel Oil (UNII: 59AAO5F6HT)  
Gentiana Lutea Root (UNII: S72O3284MS)  
Lemon Oil (UNII: I9GRO824LL)  
Menthol (UNII: L7T10EIP3A)  
Magnesium Stearate (UNII: 70097M6I30)  
Cellulose, Microcrystalline (UNII: OP1R32D61U)  
Nutmeg (UNII: AEE24M3MQ9)  
Picrasma Quassioides Wood (UNII: 75EIV4LX7W)  
Product Characteristics
ColorYELLOW (Pale Yellow) Scoreno score
ShapeROUNDSize10mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49631-212-011 in 1 CARTON
145 in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33112/01/2012
Labeler - OHTA'S ISAN CO., LTD (690771738)

Revised: 6/2012
Document Id: bd89caaa-d992-517d-1477-130c534046f0
Set id: eea230ed-8d78-9355-81a7-d08722aed708
Version: 1
Effective Time: 20120607
 
OHTA'S ISAN CO., LTD