FDA.reportPublic FDA data

Premier Value Smooth Antacid Extra Strength

Manufacturer
Chain Drug Consortium
Effective date
2024-10-28
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:30:50

Label at a glance#

ProductPremier Value Smooth Antacid Extra Strength Assorted Fruit
Active ingredientCALCIUM CARBONATE
Label structure8 sections

Indications and uses

relieves: • heartburn • sour stomach • acid indigestion • upset stomach associated with these symptoms

Dosage and administration

• adults and children 12 years of age and over: chew 2-4 tablets completely as symptoms occur, or as directed by a doctor. Do not swallow tablets whole. • do not take for symptoms that persist for more than 2 weeks unless advised by a doctor.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Calcium Carbonate USP 750mg

Purpose

OTC - PURPOSE SECTION

Antacid

Uses

INDICATIONS & USAGE SECTION

relieves:

• heartburn

• sour stomach

• acid indigestion

• upset stomach associated with these symptoms

Warnings

WARNINGS SECTION

Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs.

When using this product

• do not take more than 10 tablets in 24 hours

• if pregnant do not take more than 6 tablets in 24 hours

• do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor

Directions

DOSAGE & ADMINISTRATION SECTION

• adults and children 12 years of age and over: chew 2-4 tablets completely as symptoms occur, or as directed by a doctor. Do not swallow tablets whole.

• 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 300mg

• Store at room temperature. Keep the container tightly closed

Inactive ingredients

INACTIVE INGREDIENT SECTION

adipic acid, blue 1 lake, dextrose, flavors, magnesium stearate, maltodextrin, red 27 lake, starch, sucralose, yellow 6 lake, yellow 10 lake.

Safety sealed: Do not use if printed seal under cap is torn or missing

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the Active Ingredient in Tums Smoothies™ E-X*

Premier Value

Extra Strength

Smooth Antacid Tablets

Assorted Fruit Flavor

Calcium Rich

For Fast Relief of Heartburn, Acid Indigestion & Upset Stomach

90 Smooth Dissolve Chewable Tablets

Distributed by

Chain Drug Consortium, LLC.

3301 N.W. Boca Raton Blvd.,

Suite 101, Boca Raton FL 33431

This product is not manufactured or distributed by GlaxoSmithKline, the distributor of Tums®

Premier Value Extra Strength Smooth Antacid Tablets Assorted Fruit
Premier Value Extra Strength Smooth Antacid Tablets Assorted Fruit

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308907calcium carbonate 500 MG (Ca 200 MG) Chewable TabletPSN6
308907calcium carbonate 500 MG Chewable TabletSCD6
308907calcium carbonate 500 MG (equivalent to calcium 200 MG) Chewable TabletSY6

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
68016-675-002021-10-13C16284748780-1ba0f9c33-3291-a910-e053-dadaa90a0b85Premier Value Extra Strength Smooth Antacid
68016-675-002021-01-29C16284748780-1ba0f9c33-3291-a910-e053-dadaa90a0b85Premier Value Extra Strength Smooth Antacid

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-675-00Premier Value Smooth Antacid Extra StrengthAssorted Fruit90 in 1 BOTTLE, PLASTICTABLET, CHEWABLE906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-675PREMIER VALUE SMOOTH ANTACID EXTRA STRENGTH ASSORTED FRUIT (ANTACID TABLETS) TABLET, CHEWABLE [CHAIN DRUG CONSORTIUM]6Current NDC, Legacy NDC, 1 package rows20241030_0de2c4c5-46fb-4081-aa96-b36794e3983f.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68016-67568016-675-00

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
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
D&C RED NO. 272LRS185U6KIACT
STARCH, CORNO8232NY3SJIACT
SUCRALOSE96K6UQ3ZD4IACT
FD&C YELLOW NO. 6H77VEI93A8IACT
D&C YELLOW NO. 1035SW5USQ3GIACT

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
Premier Value Smooth Antacid Extra Strength Assorted FruitANTACID TABLETSChain Drug Consortium0de2c4c5-46fb-4081-aa96-b36794e3983f2024-10-28WarningsExact identifier
ndc (package): 68016-675-00
ndc (product): 68016-675
ndc11 (package): 68016067500
spl id: 0b9b9a00-e473-4b9b-ad0e-b36451371cb7
spl set id: 0de2c4c5-46fb-4081-aa96-b36794e3983f

Reported adverse events (FAERS/openFDA)#

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