FDA.reportPublic FDA data

LEGEND PREMIUM HEARTBURN 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 23:19:34

Label at a glance#

ProductLEGEND PREMIUM HEARTBURN CHEWABLE
Active ingredientCALCIUM CARBONATE, DIMETHICONE
Label structure8 sections

Indications and uses

● acid indigestion ● heartburn ● sour stomach ● upset stomach associated with these symptoms ● bloating, pressure, or stuffed feeling commonly referred to as gas

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 Ingredients

OTC - ACTIVE INGREDIENT SECTION

Calcium carbonate 750 mg.

Simethicone 80 mg.

Purpose

OTC - PURPOSE SECTION

  • Antacid
  • Antigas

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
● bloating, pressure, or stuffed feeling commonly referred to as gas

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
● store at room temperature. Avoid excessive heat above 40oC (104 F).

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Dextrose monohydrate, Saccharin sodium, Sucrose, Dokudami extract, FD&C Red No. 3, Povidone K30, Water, Xylitol, Sorbitol, Magnesium Stearate, Peppermint, Silicon Dioxide

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1492387calcium carbonate 750 MG / simethicone 80 MG Chewable TabletPSN1
1492387calcium carbonate 750 MG / simethicone 80 MG Chewable TabletSCD1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CALCIUM CATION Pharmacologic Class Indexing3Indexing - Pharmacologic Class20230427
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13411-844-242022-01-28C16284748780-1d6a99b39-8fdf-a426-e053-dadaa90af4c2LEGEND PREMIUM HEARTBURN GAS RELIEF CHEWABLE
13411-844-302022-01-28C16284748780-1d6a99b39-8fdf-a426-e053-dadaa90af4c2LEGEND PREMIUM HEARTBURN GAS RELIEF CHEWABLE
13411-844-602022-01-28C16284748780-1d6a99b39-8fdf-a426-e053-dadaa90af4c2LEGEND PREMIUM HEARTBURN GAS RELIEF CHEWABLE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13411-844-24LEGEND PREMIUM HEARTBURN CHEWABLE24 in 1 BOXTABLET241
13411-844-30LEGEND PREMIUM HEARTBURN CHEWABLE30 in 1 BOXTABLET301
13411-844-60LEGEND PREMIUM HEARTBURN CHEWABLE60 in 1 BOXTABLET601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13411-844LEGEND PREMIUM HEARTBURN CHEWABLE (CALCIUM CARBONATE) TABLET [ADVANCED PHARMACEUTICAL SERVICES, INC. DBA AFFORDABLE QUALITY PHARMACEUTICALS]1Legacy NDC, 3 package rows20200630_fc85cff6-3449-4f86-9afc-2653842d6d28.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
13411-84413411-844-24, 13411-844-30, 13411-844-60

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
DIMETHICONE92RU3N3Y1OACTIB
DEXTROSE MONOHYDRATELX22YL083GIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SUCROSEC151H8M554IACT
HOUTTUYNIA CORDATA FLOWERING TOPRH041UUZ22IACT
FD&C RED NO. 3PN2ZH5LOQYIACT
POVIDONE K30U725QWY32XIACT
WATER059QF0KO0RIACT
XYLITOLVCQ006KQ1EIACT
SORBITOL506T60A25RIACT
MAGNESIUM STEARATE70097M6I30IACT
PEPPERMINTV95R5KMY2BIACT
SILICON DIOXIDEETJ7Z6XBU4IACT

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
5f42f4e8-29fa-4cf9-947b-48d8f75e8622fc85cff6-3449-4f86-9afc-2653842d6d282020-06-22WarningsExact identifier
spl id: 5f42f4e8-29fa-4cf9-947b-48d8f75e8622
spl set id: fc85cff6-3449-4f86-9afc-2653842d6d28

Reported adverse events (FAERS/openFDA)#

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