LEGEND PREMIUM HEARTBURN RELIEF - EXTRA STRENGTH CHEWABLE

Manufacturer
ADVANCED PHARMACEUTICAL SERVICES, INC. DBA AFFORDABLE QUALITY PHARMACEUTICALS
Effective date
2020-06-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:19:28

Label at a glance#

ProductLEGEND PREMIUM HEARTBURN RELIEF - EXTRA STRENGTH CHEWABLE
Active ingredientCALCIUM CARBONATE
Label structure8 sections

Indications and uses

● acid indigestion. ● heartburn. ● sour stomach. ● upset stomach associated with these symptoms.

Dosage and administration

● adults and children 12 years and over: fully chew then swallow 1 or 2 chewable tablets as symptoms occur, or as directed by a doctor. ● children under 12 years: consult a doctor. ● do not take more than 5 chewable tablets in a 24-hour period.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Calcium carbonate 750 mg

Purpose

OTC - PURPOSE SECTION

Antacid

Warnings

WARNINGS SECTION


Do not use if you have ever had an allergic reaction to this product or any of its ingredients

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 5 chewable tablets in a 24-hour period
● Do not use the maximum dosage of this product for more than 2 weeks except under the advice and supervision of a physician
● Constipation may occur

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

Uses for the relief of

INDICATIONS & USAGE SECTION


● acid indigestion.

● heartburn.

● sour stomach.

● upset stomach associated with these symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

● adults and children 12 years and over: fully chew then swallow 1 or 2 chewable tablets as symptoms occur, or as directed by a doctor.
● children under 12 years: consult a doctor.
● do not take more than 5 chewable tablets in a 24-hour period.

Other information

SPL UNCLASSIFIED SECTION

● each chewable tablet contains: calcium 300 mg.
● contains FD&C Blue No. 1 as a color additive.
● store at room temperature. Avoid humidity.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Dextrose monohydrate, Saccharin sodium, Sucrose, Dokudami extract, FD&C Blue No. 1, Povidone K30, Water, Xylitol, Sorbitol, Magnesium Stearate, Peppermint, Silicon Dioxide

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308915calcium carbonate 750 MG (Ca 300 MG) Chewable TabletPSN1
308915calcium carbonate 750 MG Chewable TabletSCD1
308915calcium carbonate 750 MG (calcium 300 MG) Chewable TabletSY1

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
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13411-843-24LEGEND PREMIUM HEARTBURN RELIEF - EXTRA STRENGTH CHEWABLE24 in 1 BOXTABLET241
13411-843-30LEGEND PREMIUM HEARTBURN RELIEF - EXTRA STRENGTH CHEWABLE30 in 1 BOXTABLET301
13411-843-60LEGEND PREMIUM HEARTBURN RELIEF - EXTRA STRENGTH CHEWABLE60 in 1 BOXTABLET601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13411-843LEGEND PREMIUM HEARTBURN RELIEF - EXTRA STRENGTH CHEWABLE (CALCIUM CARBONATE) TABLET [ADVANCED PHARMACEUTICAL SERVICES, INC. DBA AFFORDABLE QUALITY PHARMACEUTICALS]1Legacy NDC, 3 package rows20200630_8601a194-fdf1-4a33-854e-153a7a2c578e.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
13411-84313411-843-24, 13411-843-30, 13411-843-60

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

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
9745e6c6-cba8-4238-b344-5821a2939fa48601a194-fdf1-4a33-854e-153a7a2c578e2020-06-22WarningsExact identifier
spl id: 9745e6c6-cba8-4238-b344-5821a2939fa4
spl set id: 8601a194-fdf1-4a33-854e-153a7a2c578e

Reported adverse events (FAERS/openFDA)#

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