FDA.reportPublic FDA data

Ultra Strength Antacid Assorted Berries

Manufacturer
Guardian Drug Company
Effective date
2025-02-06
Label type
Human OTC Drug Label
Version
1
Source
full-release
Hydrated at
2026-06-01 00:54:43

Label at a glance#

ProductUltra Strength Antacid Assorted Berries
Active ingredientCALCIUM CARBONATE
Label structure12 sections

Dosage and administration

adults and children 12 years of age and over:  wet in mouth before chewing, 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 the 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: wet in mouth before chewing, 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 the cap is torn or missing
  • store at room temperature. keep the container tightly closed.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

adipic acid, corn starch, crospovidone, dextrose, FD&C blue 1 lake, FD&C red 40 lake, flavors, magnesium stearate, maltodextrin, sucrose, talc.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in Tums® Ultra Strength*


GUARDIAN 


NDC 53041-161-68 


Ultra Strength

Alkums

Antacid Tablets

Assorted Berry Flavors

Calcium Carbonate 1000 mg


Relieves:

  • Acid Indigestion
  • Heartburn and 

72 CHEWABLE TABLETS


171ab-72-gdc.jpg
171ab-72-gdc.jpg

  


DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308892calcium carbonate 1000 MG (Ca 400 MG) Chewable TabletPSN1
308892calcium carbonate 1000 MG Chewable TabletSCD1
308892calcium carbonate 1000 MG (calcium 400 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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53041-161-68Ultra Strength Antacid Assorted Berries72 in 1 BOTTLETABLET, CHEWABLE721

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53041-161ULTRA STRENGTH ANTACID ASSORTED BERRIES (CALCIUM CARBONATE) TABLET, CHEWABLE [GUARDIAN DRUG COMPANY]1Current NDC, 1 package rows20250210_7f0ca229-7452-4f18-bd2f-bf2dfc3482f8.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53041-16153041-161-68

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALCIUM CARBONATEH0G9379FGKACTIB
ADIPIC ACID76A0JE0FKJIACT
STARCH, CORNO8232NY3SJIACT
CROSPOVIDONE2S7830E561IACT
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
FD&C BLUE NO. 1 ALUMINUM LAKEJ9EQA3S2JMIACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
SUCROSEC151H8M554IACT
TALC7SEV7J4R1UIACT
FD&C RED NO. 40 ALUMINUM LAKE6T47AS764TIACT

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 BerriesCALCIUM CARBONATEGuardian Drug Company7f0ca229-7452-4f18-bd2f-bf2dfc3482f82025-02-06WarningsExact identifier
ndc (package): 53041-161-68
ndc (product): 53041-161
ndc11 (package): 53041016168
spl id: 7f0ca229-7452-4f18-bd2f-bf2dfc3482f8
spl set id: 7f0ca229-7452-4f18-bd2f-bf2dfc3482f8

Reported adverse events (FAERS/openFDA)#

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