MedPath

Exchange Select Antacid

Xiamen-AAFES Soft Chews

Approved
Approval ID

3de81025-b81c-374a-e063-6394a90a00cf

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 3, 2025

Manufacturers
FDA

Xiamen Kang Zhongyuan Biotechnology Co., Ltd.

DUNS: 411759931

Products 1

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

Calcium Carbonate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code83698-591
Application NumberM001
Product Classification
M
Marketing Category
C200263
G
Generic Name
Calcium Carbonate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 3, 2025
FDA Product Classification

INGREDIENTS (11)

GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
SKIM MILKInactive
Code: 6A001Y4M5A
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
MALTOSE SYRUPInactive
Code: 00JKR0NZ8O
Classification: IACT
PALM OILInactive
Code: 5QUO05548Z
Classification: IACT
C14-18 MONO-AND DI-GLYCERIDESInactive
Code: 82TZ9D9546
Classification: IACT
CALCIUM CARBONATEActive
Quantity: 1177 mg in 1 1
Code: H0G9379FGK
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 7/7/2025

Soft Chews

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 10/10/2024

Uses

Relieves

  • heartburn
  • acid indigestion
  • sour stomach
  • upset stomach associated with these symptoms

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 10/10/2024

Active ingredient (in each chew)

Calcium carbonate 1,177 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 10/10/2024

Purpose

Antacid

WARNINGS SECTION

LOINC: 34071-1Updated: 10/10/2024

Warnings

Ask a doctor or pharmacist before use if you are

  • presently taking a prescription drug. Antacids may interact with certain perscription drugs.

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 10/10/2024

When using this product

  • do not take more than 6 chews in 24 hours
  • do not use the maximum dosage of this product for more than 2 weeks except under the advice and supervision of a doctor
  • if pregnant do not take more than 4 chews in 24 hours

OTC - PREGNANCY OR BREAST FEEDING SECTION

LOINC: 53414-9Updated: 10/10/2024

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 10/10/2024

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 10/10/2024

Directions

  • Adults and children 12 years of age and over: chew 2-3 chews, completely as symptoms occur, 2 times daily or as directed by a doctor. Do not swallow chews whole.
  • Do not take for symptoms that persist for mare than 2 weekis unless advised by a doctor

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 10/10/2024

Other information

***Each chew contains:**calcium 470 mg

  • Store at room temperatrue 20-25ºC (68-77ºF). Keep bag tightly closed.
  • Do not use if packaging is torn or damaged.
  • Contains: soy

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 10/10/2024

Inactive ingredients:

FD&C Red No. 40, Flaors, Gelatin, Glycerin, Soy Lecithin, Maltose Syrup, Mono and Di-glycerides of Fatty Acids, Nonfat dry milk, Palm Oil, Sucralose, Sucrose Fatty Acid Esters.

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 10/10/2024

Questions or comments? (866) 306-9136

You may also report serious side effects to this phone number.

Mon-Fri 9:00 a.m - 5:00 p.m ET

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