FDA.reportPublic FDA data

DGH Antacid Ultra Strength 1000 Fruit assorted 72ct

Manufacturer
BioV Health Inc
Effective date
2024-04-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:10:40

Label at a glance#

ProductDGH Antacid Ultra Strength 1000 Fruit assorted 72ct
Active ingredientCALCIUM CARBONATE
Label structure8 sections

Dosage and administration

Adults and children 12 years of age and over : chew 2-3 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.

Label contents#

Full prescribing information#

Active ingredient (per tablet)

OTC - ACTIVE INGREDIENT SECTION

Calcium Carbonate 1000mg

Purpose

OTC - PURPOSE SECTION

Antacid

USE

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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 7 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 of reach of children

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and over: chew 2-3 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.

Other information

SPL UNCLASSIFIED SECTION

each tablet contains: elemental calcium 400 mg. Store at room temperature. Keep the container tightly closed.

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C Red No.27 lake, D&C Yellow No.10 lake, FD&C Blue No.1 lake, FD&C Yellow No.6 lake, flavors, guar gum, hypromellose, magnesium stearate, sorbitol, sucralose.

Questions or comments?

OTC - QUESTIONS SECTION

1-888-309-9030   

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308892calcium carbonate 1000 MG (Ca 400 MG) Chewable TabletPSN2
308892calcium carbonate 1000 MG Chewable TabletSCD2
308892calcium carbonate 1000 MG (calcium 400 MG) Chewable TabletSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71481-001-012025-07-29C16284748780-11030e365-1c6f-111a-e063-dadaa90a10e2DGH Antacid Ultra Strength 1000 Fruit assorted
71481-001-012024-04-04C16284748780-11030e365-1c6f-111a-e063-dadaa90a10e2DGH Antacid Ultra Strength 1000 Fruit assorted
71481-001-012024-01-30C16284748780-11030e365-1c6f-111a-e063-dadaa90a10e2DGH Antacid Ultra Strength 1000 Fruit assorted

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71481-001-01DGH Antacid Ultra Strength 1000 Fruit assorted 72ct72 in 1 BOTTLETABLET722

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71481-001DGH ANTACID ULTRA STRENGTH 1000 FRUIT ASSORTED 72CT (CALCIUM CARBONATE) TABLET [BIOV HEALTH INC]2Legacy NDC, 1 package rows20240405_d953d292-18de-d7f3-e053-2995a90a4ce4.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71481-00171481-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
D&C RED NO. 272LRS185U6KIACT
D&C YELLOW NO. 10 ALUMINUM LAKECQ3XH3DET6IACT
FD&C BLUE NO. 1 ALUMINUM LAKEJ9EQA3S2JMIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
GUAR GUME89I1637KEIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
CALCIUM CARBONATEH0G9379FGKACTIB

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
1549ae0a-2b97-1d66-e063-6394a90a5188d953d292-18de-d7f3-e053-2995a90a4ce42024-04-04WarningsExact identifier
spl id: 1549ae0a-2b97-1d66-e063-6394a90a5188
spl set id: d953d292-18de-d7f3-e053-2995a90a4ce4

Reported adverse events (FAERS/openFDA)#

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