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 packet <1.3g>)

Precipitated calcium carbonate 497 mg

Sodium bicarbonate 600 mg

Purpose

Antacid

Antacid

Uses

relieves:

Warnings

Do not take more than 3 packets 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 of a 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 packet with water, 3 times daily, or as directed by a physician.

Other information

each packet contains: sodium 164 mg.

Inactive ingredients

cinnamon bark, citrus unshiu peel, clove, fennel, gentian, l-menthol, magnesium carbonate, nutmeg, powdered picrasma wood.

Principal Display Panel – 16 Packets Box Label

NDC 49631-178-13

Graphic – Ohta's Isan Logo

Ohta's Isan ANTACID POWDER

Heartburn Herb Flavored

Acid Upset

Indigestion Stomach

OHTA'S ISAN MADE IN JAPAN 16 Packets

Principal Display Panel – 16 Packets Box 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:49631-178-131 in 1 BOX07/01/2017
116 in 1 DOSE PACK
11.3 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33107/01/2017
Labeler - OHTA'S ISAN CO.,LTD. (690771738)
Establishment
NameAddressID/FEIBusiness Operations
OHTA'S ISAN CO.,LTD.715739137manufacture(49631-178)

Revised: 11/2022
Document Id: ece67c0d-3dd8-c117-e053-2995a90a6051
Set id: 8723fe90-8402-4511-b6c6-b71cf98513e3
Version: 3
Effective Time: 20221107
 
OHTA'S ISAN CO.,LTD.