FDA.reportPublic FDA data

GDC Extra strength Alkums Antacid 127AF

Manufacturer
Guardian Drug Company
Effective date
2024-08-13
Label type
Human OTC Drug Label
Version
2
Source
full-release
Hydrated at
2026-06-01 00:17:09

Label at a glance#

ProductGDC Extra strength Alkums Antacid 127AF
Active ingredientCALCIUM CARBONATE
Label structure12 sections

Dosage and administration

adults  and children 12 years age and over: wet in mouth before chewing  chew 2-4 tablets as symptoms occur, or as directed by a doctor.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT(S)

OTC - ACTIVE INGREDIENT SECTION

Calcium carbonate 750 mg

PURPOSE

OTC - PURPOSE SECTION

Antacid

USE(S)

INDICATIONS & USAGE SECTION

relieves:

acid indigestion 

heartburn

WARNINGS

WARNINGS SECTION

.

ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE

OTC - ASK DOCTOR/PHARMACIST SECTION

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

WHEN USING THIS PRODUCT

OTC - WHEN USING SECTION

do not take more than 10 tablets in a 24 hour period, or use the maximum dosage of this product for more than 2 weeks, under the advice and supervision of a doctor.

IF PREGNANCY/BREAST-FEEDING,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • adults  and children 12 years age and over:
  • wet in mouth before chewing 
  • chew 2-4 tablets as symptoms occur, or as directed by a doctor.

OTHER INFORMATION

OTHER SAFETY INFORMATION

  • each tablet contains: elemental calcium 300 mg , magnesium 10 mg
  • store at room temperature. Keep the container tightly closed.

INACTIVE INGRADIENTS

INACTIVE INGREDIENT SECTION

adipic acid, corn starch, crospovidone, d&c red 27 lake, D&C red  30 lake, D&C yellow 10 lake, dextrose , FD&C blue 1 lake, FD&C yellow 6 lake, flavors, magnesium  stearate, maltodextrin, sucrose, talc

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

*Compare to the active ingredient in TUMS® EX

GUARDIAN®

NDC 53041-102-22

Extra Strength

Alkums Antacid Tablets

Assorted Fruit Flavors

Calcium Carbonate 750 mg

Relieves :

  • Acid Indigestion
  • Heartburn

96 CHEWABLE TABLETS

127af-gdc-96.jpg
127af-gdc-96.jpg
127af-gdc-96.jpg
127af-gdc-96.jpg

*Compare to the active ingredient in TUMS® EX

GUARDIAN®

NDC 53041-102-13

Extra Strength Alkums Antacid Tablets

Assorted Fruit Flavors

Calcium Carbonate 750 mg

Relieves :

  • Acid Indigestion
  • Heartburn

48 CHEWABLE TABLETS

127af-gdc-48-front.jpg127af-gdc-48-front.jpg

127af-gdc-48-back.jpg127af-gdc-48-back.jpg

127af-gdc-48-back.jpg127af-gdc-48-back.jpg

127af-gdc-48-front.jpg127af-gdc-48-front.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308915calcium carbonate 750 MG (Ca 300 MG) Chewable TabletPSN2
308915calcium carbonate 750 MG Chewable TabletSCD2
308915calcium carbonate 750 MG (calcium 300 MG) Chewable TabletSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CALCIUM CATION Pharmacologic Class Indexing3Indexing - Pharmacologic Class20230427

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53041-102-13GDC Extra strength Alkums Antacid 127AF48 in 1 BOTTLETABLET, CHEWABLE482
53041-102-22GDC Extra strength Alkums Antacid 127AF96 in 1 BOTTLETABLET, CHEWABLE962

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53041-102GDC EXTRA STRENGTH ALKUMS ANTACID 127AF (CALCIUM CARBONATE) TABLET, CHEWABLE [GUARDIAN DRUG COMPANY]2Current NDC, 2 package rows20240815_1b6da4a3-cfa6-6d98-e063-6394a90a5889.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53041-10253041-102-22, 53041-102-13

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALCIUM CARBONATEH0G9379FGKACTIM
ADIPIC ACID76A0JE0FKJIACT
STARCH, CORNO8232NY3SJIACT
CROSPOVIDONE2S7830E561IACT
D&C RED NO. 27 ALUMINUM LAKEZK64F7XSTXIACT
D&C RED NO. 30 ALUMINUM LAKEGE75M6YV5WIACT
D&C YELLOW NO. 10 ALUMINUM LAKECQ3XH3DET6IACT
DEXTROSEIY9XDZ35W2IACT
FD&C BLUE NO. 1 ALUMINUM LAKEJ9EQA3S2JMIACT
FD&C YELLOW NO. 6 ALUMINUM LAKEGYP6Z2JR6QIACT
MAGNESIUM STEARATE70097M6I30IACT
SUCROSEC151H8M554IACT
TALC7SEV7J4R1UIACT
MALTODEXTRIN7CVR7L4A2DIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GDC Extra strength Alkums Antacid 127AFCALCIUM CARBONATEGuardian Drug Company1b6da4a3-cfa6-6d98-e063-6394a90a58892024-08-13WarningsExact identifier
ndc (package): 53041-102-22
ndc (package): 53041-102-13
ndc (product): 53041-102
ndc11 (package): 53041010213
ndc11 (package): 53041010222
spl id: 6a87e1e4-5e8e-4102-b693-5413b6659b87
spl set id: 1b6da4a3-cfa6-6d98-e063-6394a90a5889

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.