FDA.reportPublic FDA data

Premier Value ® Extra Strength Antacid Tablets Freshmint Flavor

Manufacturer
CHAIN DRUG CONSORTIUM, LLC
Effective date
2024-10-25
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:30:06

Label at a glance#

ProductPremier Value Extra Strength Freshmint Flavor
Active ingredientCALCIUM CARBONATE, MAGNESIUM HYDROXIDE
Label structure9 sections

Indications and uses

relieves: ▪ heartburn ▪ sour stomach ▪ acid indigestion

Dosage and administration

▪ chew 2-4 tablets completely as symptoms occur or as directed by a doctor. Do not swallow tablet whole.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Calcium Carbonate USP 675 mg
Magnesium hydroxide USP 135 mg

Purpose

OTC - PURPOSE SECTION

Antacid

Antacid

Uses

INDICATIONS & USAGE SECTION

relieves:

  • heartburn
  • sour stomach
  • acid indigestion

Warnings

WARNINGS SECTION

Ask a doctor or pharmacist before use if you are 

OTC - ASK DOCTOR/PHARMACIST SECTION

now taking a prescription drug. Antacids may interact with certain prescription drugs.

When using this product

OTC - WHEN USING SECTION

  • do not take more than 10 tablets in a 24-hour period
  • do not use the maximum dosage for more than 2 weeks.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

  • chew 2-4 tablets completely as symptoms occur or as directed by a doctor. Do not swallow tablet whole.

Other information

SPL UNCLASSIFIED SECTION

  • each tablet contains: calcium 270 mg, magnesium 55 mg
  • store room temperature
  • Avoid high humidity.

DO NOT USE IF PRINTED INNER SEAL IS BROKEN OR MISSING

CALCIUM SUPPLEMENT

USES

As a daily source of calcium and magnesium, chew 2 tablets, completely twice daily

Supplement Facts

Serving Size: 2 Tablets

Servings Per Container: 50

Amount Per Serving

% Daily Value

Calories 8

Total Carbohydrate 2g

1%

Total Sugars 2g

†

Includes 2 g Added Sugar

4%

Calcium 540 mg

42%

Magnesium 110 mg

26%

*Percent Daily Values (DV) are based on a 2,000 calories diet.

†Daily Value not established.

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, dextrose, flavor, magnesium stearate, maltodextrin, sucralose.

Questions?

OTC - QUESTIONS SECTION

1-866-467-2748

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Premier Value®

NDC# 68016-678-00

COMPARE TO ACTIVE INGREDIENTS IN ROLAIDS® EXTRA STRENGTH*

Extra Strength

Antacid Tablets

Freshmint Flavor

Relieves:

  • Heartburn
  • Acid Indigestion

Antacid/Calcium Supplement

100 CHEWABLE TABLETS

GLUTEN FREE

TAMPER EVIDENT: DO NOT USE IF PRINTED INNER SEAL IS BROKEN OR MISSING

*This product is not manufactured or distributed by Chattem Inc., owner of the registered trademark Extra Strength Rolaids®

Distributed by:

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue,

Wayne, PA 19087

Premier Value Extra Strength Antacid tablets
Premier Value Extra Strength Antacid tablets

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
476549calcium carbonate 675 MG (Ca 270 MG) / magnesium hydroxide 135 MG Chewable TabletPSN6
476549calcium carbonate 675 MG / magnesium hydroxide 135 MG Chewable TabletSCD6
476549calcium carbonate 675 MG / milk of magnesia 135 MG Chewable TabletSY6

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CALCIUM CATION Pharmacologic Class Indexing3Indexing - Pharmacologic Class20230427
MAGNESIUM CATION Pharmacologic Class Indexing4Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
95250459-30e4-45c1-b08a-993044f49109Product name220250805
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-678-00Premier Value Extra StrengthFreshmint Flavor100 in 1 BOTTLE, PLASTICTABLET, CHEWABLE1006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-678PREMIER VALUE EXTRA STRENGTH FRESHMINT FLAVOR (CALCIUM CARBONATE ,MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [CHAIN DRUG CONSORTIUM, LLC]6Current NDC, Legacy NDC, 1 package rows20241028_1192ebeb-f6cc-45db-8f07-12d36eb55a5f.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68016-67868016-678-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALCIUM CARBONATEH0G9379FGKACTIB
MAGNESIUM HYDROXIDENBZ3QY004SACTIB
STARCH, CORNO8232NY3SJIACT
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
SUCRALOSE96K6UQ3ZD4IACT

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 Extra Strength Freshmint FlavorCALCIUM CARBONATE ,MAGNESIUM HYDROXIDECHAIN DRUG CONSORTIUM, LLC1192ebeb-f6cc-45db-8f07-12d36eb55a5f2024-10-25WarningsExact identifier
ndc (package): 68016-678-00
ndc (product): 68016-678
ndc11 (package): 68016067800
spl id: 38ac34e7-3a06-4719-a8a5-9c5dcd755133
spl set id: 1192ebeb-f6cc-45db-8f07-12d36eb55a5f

Reported adverse events (FAERS/openFDA)#

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