OHTAS ISAN ANTACID- calcium carbonate, sodium bicarbonate powder 
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 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,  l-menthol, nutmeg, powdered picrasma wood, magnesium carbonate.

Principal Display Panel - Can Label

Ohta's Isan NDC 49631-178-21

ANTACID POWDER

NET WT 2.65 OZ (75g)

Principal Display Panel - Can Label

Principal Display Panel - Can Label

Ohta's Isan NDC 49631-178-22

ANTACID POWDER

NET WT 4.94 OZ (140g)

Principal Display Panel - Can Label
OHTAS ISAN ANTACID 
calcium carbonate, sodium bicarbonate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49631-178
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE1 g  in 1 g
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE1 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
CINNAMON (UNII: 5S29HWU6QB)  
TANGERINE (UNII: KH3E3096OO)  
CLOVE (UNII: K48IKT5321)  
FENNEL (UNII: 557II4LLC3)  
GENTIANA LUTEA ROOT (UNII: S72O3284MS)  
LEVOMENTHOL (UNII: BZ1R15MTK7)  
NUTMEG (UNII: AEE24M3MQ9)  
PICRASMA QUASSIOIDES WOOD (UNII: 75EIV4LX7W)  
MAGNESIUM CARBONATE (UNII: 0E53J927NA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49631-178-211 in 1 BOX10/16/2000
175 g in 1 CAN; Type 0: Not a Combination Product
2NDC:49631-178-221 in 1 BOX10/16/2000
2140 g in 1 CAN; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33110/16/2000
Labeler - OHTA'S ISAN CO.,LTD. (690771738)
Establishment
NameAddressID/FEIBusiness Operations
OHTA'S ISAN CO.,LTD.715739137manufacture(49631-178)

Revised: 11/2022
Document Id: ece66f36-d132-71f4-e053-2995a90a9cd2
Set id: 53380470-5748-6fa7-548e-7484ef204c0f
Version: 5
Effective Time: 20221107
 
OHTA'S ISAN CO.,LTD.