FDA.reportPublic FDA data

Premier Value ® Extra Strength Chewable Tablets Original Flavor

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 Extra Strength Original Flavor
Active ingredientALUMINUM HYDROXIDE, MAGNESIUM CARBONATE
Label structure8 sections

Indications and uses

relieves ▪ acid indigestion ▪ heartburn ▪ sour stomach ▪ upset stomach associated with these symptoms

Dosage and administration

▪ chew 2 to 4 tablets completely four times a day or as directed by a doctor ▪ take after meals and at bedtime or as needed ▪ for best results follow by a half glass of water or other liquid ▪ DO NOT SWALLOW TABLETS WHOLE

Label contents#

Full prescribing information#

Active ingredients (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Aluminum hydroxide 160 mg

Magnesium carbonate 105 mg

Purpose

OTC - PURPOSE SECTION

Antacid

Antacid

Uses

INDICATIONS & USAGE SECTION

relieves

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

Warnings

WARNINGS SECTION

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking a prescription drug. Antacids may interact with certain prescription drugs
  • If you are on a sodium-restricted diet

When using this product

OTC - WHEN USING SECTION

  • do not take more than 16 tablets in 24 hours
  • 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

In case of overdose, get medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Directions

DOSAGE & ADMINISTRATION SECTION

  • chew 2 to 4 tablets completely four times a day or as directed by a doctor
  • take after meals and at bedtime or as needed
  • for best results follow by a half glass of water or other liquid
  • DO NOT SWALLOW TABLETS WHOLE

Other information

SPL UNCLASSIFIED SECTION

  • each tablet contains: magnesium 31 mg, sodium 19 mg
  • Store at room temperature.

Inactive ingredients

INACTIVE INGREDIENT SECTION

alginic acid, calcium stearate, compressible sugar, flavor, sodium bicarbonate, starch (corn), sucrose.

Questions or comments?

OTC - QUESTIONS SECTION

1-866-467-2748

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Premier Value®

NDC 68016-105-10

Heartburn Antacid

COMPARE TO THE ACTIVE INGREDIENTS IN EXTRA STRENGTH GAVISCON®

EXTRA STRENGTH

Aluminum Hydroxide, 160 mg

Magnesium Carbonate, 105 mg

  • Fast-Acting Heartburn Relief
  • Helps Keep Acid Down for Hours

100 CHEWABLE TABLETS

Distributed By:

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue,

Wayne, PA 19087

DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS BROKEN OR MISSING

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 GlaxoSmithKline, the distributor of Gaviscon® Extra Strength Antacid.

Heartburn Antacid Original Flavor 100 Chewable Tablets
Heartburn Antacid Original Flavor 100 Chewable Tablets

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308072aluminum hydroxide 160 MG / magnesium carbonate 105 MG Chewable TabletPSN6
308072aluminum hydroxide 160 MG / magnesium carbonate 105 MG Chewable TabletSCD6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-105-10Premier Value Extra StrengthOriginal Flavor100 in 1 BOTTLE, PLASTICTABLET, CHEWABLE1006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-105PREMIER VALUE EXTRA STRENGTH ORIGINAL FLAVOR (ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE) TABLET, CHEWABLE [PHARMACY VALUE ALLIANCE, LLC]6Current NDC, Legacy NDC, 1 package rows20241028_e33db45a-594e-4af8-ab16-10010fc8a388.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
68016-10568016-105-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALUMINUM HYDROXIDE5QB0T2IUN0ACTIB
MAGNESIUM CARBONATE0E53J927NAACTIB
ALGINIC ACID8C3Z4148WZIACT
CALCIUM STEARATE776XM7047LIACT
CORN SYRUP9G5L16BK6NIACT
SODIUM BICARBONATE8MDF5V39QOIACT
STARCH, CORNO8232NY3SJIACT
SUCROSEC151H8M554IACT

Source Document#

Source XML · Source PDF

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 Original FlavorALUMINUM HYDROXIDE AND MAGNESIUM CARBONATEPHARMACY VALUE ALLIANCE, LLCe33db45a-594e-4af8-ab16-10010fc8a3882024-10-25WarningsExact identifier
ndc (package): 68016-105-10
ndc (product): 68016-105
ndc11 (package): 68016010510
spl id: 1f6bbfd3-47ad-411b-b164-7790bd124a0a
spl set id: e33db45a-594e-4af8-ab16-10010fc8a388

Reported adverse events (FAERS/openFDA)#

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