SPL v4
SPL
SPL Set ID 8723fe90-8402-4511-b6c6-b71cf98513e3
Route
ORAL
Published
Effective Date 2019-11-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Carbonate Ion (1 g) Bicarbonate Ion
Inactive Ingredients
Cinnamon Tangerine Clove Fennel Gentiana Lutea Root Levomenthol Nutmeg Picrasma Quassioides Wood Magnesium Carbonate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-07-01
Description

Drug Facts

Purpose

Antacid Antacid

Medication Information

Purpose

Antacid

Antacid

Description

Drug Facts

Uses

relieves:

  • heartburn
  • sour stomach
  • acid indigestion
  • upset stomach due to these symptoms
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50570-1

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.

Section 51945-4

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

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

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.

Active Ingredients (in Each Packet <1.3g>)

Precipitated calcium carbonate 497 mg

Sodium bicarbonate 600 mg

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.

Structured Label Content

Uses

relieves:

  • heartburn
  • sour stomach
  • acid indigestion
  • upset stomach due to these symptoms
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50570-1 (50570-1)

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.

Section 51945-4 (51945-4)

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

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Antacid

Antacid

Direction

take 1 packet with water, 3 times daily, or as directed by a physician.

Other Information (Other information)

each packet contains: sodium 164 mg.

Inactive Ingredients (Inactive ingredients)

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

Active Ingredients (in Each Packet <1.3g>) (Active ingredients (in each packet <1.3g>))

Precipitated calcium carbonate 497 mg

Sodium bicarbonate 600 mg

Ask A Doctor of A Pharmacist Before Use If You Are (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.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:56.772425 · Updated: 2026-03-14T23:04:17.676959