FDA.reportPublic FDA data

GNP Ultra Strength Antacid Assorted Fruit Chewable Tablets

Manufacturer
Amerisource Bergen | Guardian Drug Company
Effective date
2024-06-26
Label type
Human OTC Drug Label
Version
2
Source
full-release
Hydrated at
2026-06-01 00:14:16

Label at a glance#

ProductUltra Strength Antacid Assorted Fruit
Active ingredientCALCIUM CARBONATE
Label structure12 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.

Storage and handling

each tablet contains: elemental calcium 400 mg do not use if printed seal under cap is torn or missing store at room temperature. keep the container tightly closed.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Calcium carbonate 1000 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 7 tablets in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor.

IF PREGNANT OR/BREASTFEEDING,

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 of age and over: chew 2-3 tablets as symptoms occur, or as directed by a doctor.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

  • each tablet contains: elemental calcium 400 mg
  • do not use if printed seal under cap is torn or missing
  • store at room temperature. keep the container tightly closed.

INACTIVE INGREDIENTS

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

NDC24385-595-23
Good Neighbor Pharmacy
Compare to Tums® Ultra Strength active ingredient*
ultra strength
Antacid
Calcium Carbonate 1000 mg

soothing relief for
acid indigestion, heartburn

assorted fruit flavors

72 chewable tablets

7777

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

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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
24385-595-232024-06-26C16284748780-1f386c64a-3ebf-0266-e053-dadaa90a7c1aGNP Ultra Strength Antacid Assorted Fruit Chewable Tablets
24385-595-232023-01-30C16284748780-1f386c64a-3ebf-0266-e053-dadaa90a7c1aGNP Ultra Strength Antacid Assorted Fruit Chewable Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24385-595-23Ultra Strength Antacid Assorted Fruit72 in 1 BOTTLETABLET, CHEWABLE722

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24385-595ULTRA STRENGTH ANTACID ASSORTED FRUIT (CALCIUM CARBONATE) TABLET, CHEWABLE [AMERISOURCE BERGEN]2Current NDC, Legacy NDC, 1 package rows20240627_d39b3a19-b0e7-409d-9e0b-ef847fe8be2f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24385-595-23EA - Each24385-595770d0101-b8c0-4ec3-80eb-171f4e23fec112021-06-02

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
24385-59524385-595-23

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 CARBONATEH0G9379FGKACTIB
ADIPIC ACID76A0JE0FKJIACT
STARCH, CORNO8232NY3SJIACT
CROSPOVIDONE, UNSPECIFIED2S7830E561IACT
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
SUCROSEC151H8M554IACT
TALC7SEV7J4R1UIACT
D&C RED NO. 27 ALUMINUM LAKEZK64F7XSTXIACT
D&C RED NO. 302S42T2808BIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C YELLOW NO. 6H77VEI93A8IACT

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
Ultra Strength Antacid Assorted FruitCALCIUM CARBONATEAmerisource Bergend39b3a19-b0e7-409d-9e0b-ef847fe8be2f2024-06-26WarningsExact identifier
ndc (package): 24385-595-23
ndc (product): 24385-595
ndc11 (package): 24385059523
spl id: f2b86396-9a40-491f-b53d-e24684c00339
spl set id: d39b3a19-b0e7-409d-9e0b-ef847fe8be2f

Reported adverse events (FAERS/openFDA)#

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