Exchange Select Calcium Carbonate Antacid Smoothies
AAFES-MGC-Xiamen Extra Strength Antacid (750 mg) Assorted Berry
Approved
Approval ID
3d470e3a-3c3f-d2b8-e063-6394a90a7edb
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Aug 26, 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 Code83698-590
Application NumberM001
Product Classification
M
Marketing Category
C200263
G
Generic Name
Calcium Carbonate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 26, 2025
FDA Product Classification
INGREDIENTS (8)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MALTITOLInactive
Code: D65DG142WK
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
CALCIUM CARBONATEActive
Quantity: 750 mg in 1 1
Code: H0G9379FGK
Classification: ACTIB
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 8/26/2025
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 8/26/2025
Uses
relieves
- heartburn
- acid indigestion
- sour stomach
- upset stomach associated with these symptoms
OTC - ACTIVE INGREDIENT SECTION
LOINC: 55106-9Updated: 8/26/2025
Active ingredient (in each tablet)
Calcium carbonate 750 mg
WARNINGS SECTION
LOINC: 34071-1Updated: 8/26/2025
Warnings
Ask a doctor or pharmacist before use if you are
- presently taking a prescription drug. Antacids may interact with certain prescription drugs.
When using this product
- do not take more than 10 tablets in 24 hours.
- do not use the maximum dosage of this product for more than 2 weeks except under advice and supervision of a doctor
- if pregnant do not take more than 5 tablets in 24 hours.
If pregnant or breast-feeding,
ask a health professional before use
Keep out of reach of children.
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 8/26/2025
Directions
- adults and children 12 years of age and over: chew 2-4 tablets, completely as symptoms occur, 2 times daily or as directed by a doctor. Do not swallow tablets whole.
- do not take for symptoms that persist for more than 2 weeks unless advised by a doctor.
OTC - PURPOSE SECTION
LOINC: 55105-1Updated: 8/26/2025
Purpose
Antacid
OTHER SAFETY INFORMATION
LOINC: 60561-8Updated: 8/26/2025
Other information
***each tablet contains:**calcium 300 mg
- store at room temperature (20-25°C (68-75°F)). Keep the container tightly closed.
- do not use if printed seal under cap is torn or missing
INACTIVE INGREDIENT SECTION
LOINC: 51727-6Updated: 8/12/2025
Inactive ingredients
Corn starch, FD&C Blue No.1, FD&C Red No. 40, flavors, magnesium stearate, maltitol, sucralose, sucrose
OTC - QUESTIONS SECTION
LOINC: 53413-1Updated: 8/26/2025
Questions or comments?
+1-866-306-9136
You may also report serious side effects to this phone
**number.**Mon-Fri 9:00 AM - 5:00 PM Eastern Time.