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OHTAS ISAN ANTACID by OHTA'S ISAN CO.,LTD.

Dosage form: powder
Ingredients: Calcium Carbonate 1g in 1g, Sodium Bicarbonate 1g in 1g
Labeler: OHTA'S ISAN CO.,LTD.
NDC Code: 49631-178

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.

Drug Facts

Active ingredients (in each packet <1.3g>)

Precipitated calcium carbonate 497 mg

Sodium bicarbonate 600 mg

Purpose

Antacid

Antacid

Uses

relieves:

  • heartburn
  • sour stomach
  • acid indigestion
  • upset stomach due to these symptoms

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

OHTAS ISAN ANTACID 
calcium carbonate, sodium bicarbonate powder
Product Information
Product TypeHUMAN OTC DRUGItem 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 
Levomenthol 
Nutmeg 
Picrasma Quassioides Wood 
Magnesium Carbonate 
Packaging
#Item CodePackage Description
1NDC:49631-178-1316 DOSE PACK in 1 BOX
11.3 g in 1 DOSE PACK
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/FEIOperations
OHTA'S ISAN CO.,LTD.715739137ANALYSIS(49631-178), MANUFACTURE(49631-178), PACK(49631-178), PARTICLE SIZE REDUCTION(49631-178), SALVAGE(49631-178), STERILIZE(49631-178)

 
OHTA'S ISAN CO.,LTD.

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Medically reviewed on Mar 6, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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