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KOSHER MEDS antacid

Approved
Approval ID

7783d6a2-56e3-4542-ad1d-60680e03532b

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jun 23, 2025

Manufacturers
FDA

Mollec Inc

DUNS: 040088196

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 Code82179-005
Application NumberM001
Product Classification
M
Marketing Category
C200263
G
Generic Name
Calcium carbonate
Product Specifications
Route of AdministrationORAL
Effective DateJune 23, 2025
FDA Product Classification

INGREDIENTS (8)

D&C RED NO. 27Inactive
Code: 2LRS185U6K
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
DEXTROSE, UNSPECIFIED FORMInactive
Code: IY9XDZ35W2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
CALCIUM CARBONATEActive
Quantity: 500 mg in 1 1
Code: H0G9379FGK
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 6/20/2025

Product label

image descriptionimage descriptionimage description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 6/17/2025

Uses

relieves

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 6/18/2025

Active ingredient

Calcium carbonate 500 mg (in each chewable tablet)

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 6/16/2025

Purpose

Antacid

WARNINGS SECTION

LOINC: 34071-1Updated: 6/18/2025

Warnings

Ask a doctor or pharmacist before use****if you arepresently taking a prescription drug. Antacids may interact with certain prescription drugs.

When using this product

  • do not take more than 8 tablets in 24 hours
  • if pregnant do not take more than 5 tablets in 24 hours
  • do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 6/16/2025

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 6/16/2025

Directions

adults and children 12 years of age and over:

  • chew 2-4 tablets as symptoms occur, or as directed by a doctor
  • do not take for symptoms that persist for more than 2 weeks unless advised by a doctor

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 6/16/2025

Other information

*each tablet contains: elemental calcium 200 mg

  • store at room temperature
  • keep the container tightly closed

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 6/20/2025

Inactive ingredients

Al-lakes (D&C red #27, D&C yellow #10, FD&C blue #1, FD&C yellow #6), dextrose, flavors (cherry, lemon, lime, orange), magnesium stearate, maltodextrin

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 6/18/2025

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KOSHER MEDS antacid - FDA Drug Approval Details