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        125mg 
Precipitated calcium carbonate         200mg 
Sodium bicarbonate                         200mg

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 6 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 physician.

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

chew 2 tablets, 3 times daily.

Other Information

each tablet contains: sodium 55 mg.

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 49631-182-11

Ohta's Isan

ANTACID TABLETS
Herb Flavored Antacid for the relief of heartburn, sour stomach, acid indigestion and upset stomach associated with these symptoms.

40 CHEWABLE TABLETS IN FOIL PACKET

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

DO NOT USE IF A CARTON IS DAMAGED OR FOIL PACK EACH TABLET SEALED IN IS BROKEN


PRODUCT OF JAPAN

40 Tablets
OHTAS ISAN ANTACID  
magnesium aluminosilicate, calcium carbonate, sodium bicarbonate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49631-182
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Almasilate (UNII: OZQ8O62H53) (Almasilate - UNII:OZQ8O62H53) Almasilate125 mg
Calcium Carbonate (UNII: H0G9379FGK) (Calcium Cation - UNII:2M83C4R6ZB, Carbonate Ion - UNII:7UJQ5OPE7D) Calcium Carbonate200 mg
Sodium Bicarbonate (UNII: 8MDF5V39QO) (Bicarbonate Ion - UNII:HN1ZRA3Q20) Sodium Bicarbonate200 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
ColorBROWN (Sand Color) Scoreno score
ShapeROUNDSize12mm
FlavorImprint Code OHTA
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49631-182-111 in 1 CARTON
140 in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33111/16/2000
Labeler - OHTA'S ISAN CO., LTD (690771738)

Revised: 6/2012
Document Id: 18ea7d4b-fc53-f158-0e6c-fe4ce795325c
Set id: 6fe3f999-0c6c-bf3f-a0c5-d84705bbc94e
Version: 1
Effective Time: 20120607
 
OHTA'S ISAN CO., LTD