FDA.reportPublic FDA data

Premier Value Maximum Strength

Manufacturer
PHARMACY VALUE ALLIANCE, LLC
Effective date
2024-10-25
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:30:09

Label at a glance#

ProductPremier Value Maximum Strength Assorted Fruit
Active ingredientCALCIUM CARBONATE, DIMETHICONE, UNSPECIFIED
Label structure8 sections

Indications and uses

relieves: ▪ acid indigestion ▪ heartburn ▪ sour stomach ▪ upset stomach due to these symptoms ▪ bloating and pressure commonly referred to as gas

Dosage and administration

▪ adults and children 12 years and older: chew 1 to 2 tablets completely as symptoms occur or as directed by a doctor. Do not swallow tablets whole. ▪ do not take more than 8 tablets in 24 hours or use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor.

Label contents#

Full prescribing information#

Active ingredients (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Calcium carbonate 1000 mg

Simethicone 60 mg

Purpose

OTC - PURPOSE SECTION

Antacid

Antigas

Uses

INDICATIONS & USAGE SECTION

relieves:

  • acid indigestion
  • heartburn
  • sour stomach
  • upset stomach due to these symptoms
  • bloating and pressure commonly referred to as gas

Warnings

WARNINGS SECTION

Do not take more than 8 tablets in 24 hours or use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • kidney stones
  • a calcium-restricted diet

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

at maximum dose, constipation may occur.

Stop use and ask a doctor if

OTC - STOP USE SECTION

symptoms persist for more than 2 weeks.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years and older: chew 1 to 2 tablets completely as symptoms occur or as directed by a doctor. Do not swallow tablets whole.
  • do not take more than 8 tablets in 24 hours or use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor.

Other information

SPL UNCLASSIFIED SECTION

  • each tablet contains: calcium 400 mg
  • store at room temperature
  • keep tightly closed and dry
  • avoid freezing
  • do not use if printed inner seal is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

adipic acid, D&C Yellow No. 10, dextrose, FD&C Red No. 40, FD&C Yellow No. 6, flavors, magnesium stearate, maltodextrin, silica, starch, sucralose.

Questions or comments?

OTC - QUESTIONS SECTION

1-866-467-2748

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Premier Value®

*COMPARE TO THE ACTIVE INGREDIENTS IN MAALOX® ADVANCED MAXIMUM STRENGTH

NDC: 68016-249-00

Antacid & Anti-Gas

MAXIMUM STRENGTH

Fast relief of:

  • Heartburn
  • Acid indigestion
  • Pressure & bloating
  • Assorted Fruit
  • Naturally Artificially Flavored

90 Chewable Tablets

INDEPENDENTLY TESTED PV SATISFACTION GURANTEED

Distributed by:

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue,

Wayne, PA 19087

If for any reason you are not satisfied with this product, please return it to the store where purchased for a full refund.

*This product is not manufactured or distributed by Novartis Consumer Health, Inc., the distributor of Maalox® Advanced Maximum Strength.

Premier Value Maximum Strength Assorted Fruit 90 Chewable Tablets
Premier Value Maximum Strength Assorted Fruit 90 Chewable Tablets

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
403828calcium carbonate 1000 MG (Ca 400 MG) / simethicone 60 MG Chewable TabletPSN6
403828calcium carbonate 1000 MG / simethicone 60 MG Chewable TabletSCD6
403828calcium carbonate 1000 MG (calcium 400 MG) / simethicone 60 MG Chewable TabletSY6

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

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
68016-249-00Premier Value Maximum StrengthAssorted Fruit90 in 1 BOTTLE, PLASTICTABLET, CHEWABLE906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-249PREMIER VALUE MAXIMUM STRENGTH ASSORTED FRUIT (CALCIUM CARBONATE, SIMETHICONE) TABLET, CHEWABLE [PHARMACY VALUE ALLIANCE, LLC]6Current NDC, Legacy NDC, 1 package rows20241028_e25bf9ca-415b-4a3e-a502-59074308da54.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68016-24968016-249-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALCIUM CARBONATEH0G9379FGKACTIB
DIMETHICONE, UNSPECIFIED92RU3N3Y1OACTIB
ADIPIC ACID76A0JE0FKJIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STARCH, CORNO8232NY3SJIACT
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 Maximum Strength Assorted FruitCALCIUM CARBONATE, SIMETHICONEPHARMACY VALUE ALLIANCE, LLCe25bf9ca-415b-4a3e-a502-59074308da542024-10-25WarningsExact identifier
ndc (package): 68016-249-00
ndc (product): 68016-249
ndc11 (package): 68016024900
spl id: 450c1e14-f3e9-46ec-a032-75d3cb6d2733
spl set id: e25bf9ca-415b-4a3e-a502-59074308da54

Reported adverse events (FAERS/openFDA)#

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