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Stomachin Antacid

Stomachin

Approved
Approval ID

60fa0650-8785-4cb3-8f88-1a437296252f

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 19, 2025

Manufacturers
FDA

Chang Kuo Chou Pharmaceutical Co., Ltd.

DUNS: 656241486

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

magnesium carbonate and sodium bicarbonate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code43337-9329
Application NumberM001
Product Classification
M
Marketing Category
C200263
G
Generic Name
magnesium carbonate and sodium bicarbonate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 19, 2025
FDA Product Classification

INGREDIENTS (6)

CLOVEInactive
Quantity: 29 mg in 1 g
Code: K48IKT5321
Classification: IACT
LICORICEInactive
Quantity: 86 mg in 1 g
Code: 61ZBX54883
Classification: IACT
MENTHOL, UNSPECIFIED FORMInactive
Quantity: 4 mg in 1 g
Code: L7T10EIP3A
Classification: IACT
RHUBARBInactive
Quantity: 14 mg in 1 g
Code: G280W4MW6E
Classification: IACT
MAGNESIUM CARBONATEActive
Quantity: 58 mg in 1 g
Code: 0E53J927NA
Classification: ACTIB
SODIUM BICARBONATEActive
Quantity: 809 mg in 1 g
Code: 8MDF5V39QO
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 12/14/2022

PRINCIPAL DISPLAY PANEL - 40 g Packet Box

NDC 43337-9329-9

Stomachin ®

ANTACID POWDER

Fast Relief of:

Acid indigestion
Upset stomach
Heartburn

Net weight: 1.4oz.(40g), Total 20 packets

Product of Taiwan

Principal Display Panel - 40 g Packet Box

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 12/14/2022

Uses

relieves:

  • acid indigestion
  • heartburn
  • sour stomach
  • upset stomach from overindulgence in food or drink

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 12/14/2022

Manufactured by :
** Chang Kuo Chou Pharmaceutical Co.,Ltd.**
** Taoyuan, Taiwan**

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 12/14/2022

Active ingredients (in each gram)

Purpose

Magnesium carbonate 58mg

Antacid

Sodium bicarbonate 809mg

Antacid

WARNINGS SECTION

LOINC: 34071-1Updated: 12/14/2022

Warnings

Allergy alert

Do not use if you are allergic to the antacid.

Do not usemore 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 or pharmacist before use if you are

  • presently taking a prescription drug. Antacid may interact with certain prescription drugs.
  • On magnesium or sodium restricted diet.

Stop use and ask a doctor if

  • symptoms persist or worsen.

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

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 12/14/2022

Directions

Take 2 gram (one packet) with water, 3 times a day

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 12/14/2022

Other information

  • each gram contains : magnesium 16 mg and sodium 221 mg
  • store at cool and dry place

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 12/14/2022

Inactive ingredients

clove, licorice, menthol, rhubarb

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Stomachin Antacid - FDA Drug Approval Details