Your browser does not support JavaScript! OHTAS ISAN ANTACID (CALCIUM CARBONATE, SODIUM BICARBONATE) POWDER [OHTA'S ISAN CO., LTD]
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OHTAS ISAN ANTACID (calcium carbonate, sodium bicarbonate) powder
[OHTA'S ISAN CO., LTD]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Label Sections

Active Ingredients (in each spoonful)

Precipitated calcium carbonate         497 mg 
Sodium bicarbonate                         600 mg

Purpose

Precipitated calcium carbonate ............. Antacid
Sodium bicarbonate ............................. Antacid

Uses

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

Warnings

Do not use more than 3 spoonfuls 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

take 1 spoonful (using the spoon included with this can) with water, 3 times daily.

Other Information

each spoonful contains: sodium 164 mg.

Inactive ingredients

cinnamon bark, citrus unshiu peel, clove, fennel, gentian, menthol, nutmeg, powdered picrasma wood.

PRINCIPAL DISPLAY PANEL

Ohta's Isan

NDC 49631-178-11

DO NOT USE IF IMPRINTED SAFETY SEAL AROUND THIS CAN IS BROKEN OR MISSING.

ANTACID POWDER

NET WT 2.65 OZ (75g)

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

PRODUCT OF JAPAN

75 Gram Can
OHTAS ISAN ANTACID  
calcium carbonate, sodium bicarbonate powder
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:49631-178
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Calcium Carbonate (Carbonate Ion) Calcium Carbonate1 g  in 1 g
Sodium Bicarbonate (Bicarbonate Ion) Sodium Bicarbonate1 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
Cinnamon 
Tangerine 
Clove 
Fennel 
Gentiana Lutea Root 
Menthol 
Nutmeg 
Picrasma Quassioides Wood 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49631-178-1175 g in 1 CAN
2NDC:49631-178-12140 g in 1 CAN
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33110/16/2000
Labeler - OHTA'S ISAN CO., LTD (690771738)

Revised: 6/2012
 
OHTA'S ISAN CO., LTD

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