Premier Value

Manufacturer
PHARMACY VALUE ALLIANCE, LLC
Effective date
2024-10-28
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:31:19

Label at a glance#

ProductPremier Value
Active ingredientCALCIUM POLYCARBOPHIL
Label structure9 sections

Indications and uses

▪ relieves occasional constipation to help restore and maintain regularity ▪ this product generally produces bowel movement in 12 to 72 hours

Dosage and administration

▪ Take each dose of this product with at least 8 ounces (a full glass) of water or other fluid. Taking this product without enough liquid may cause choking. (See choking warning). ▪ This product works naturally so continued use for one to three days is normally required to provide full benefit. Dosage may vary according to diet, exercise, previous laxative use or severity of constipation. Age Recommended Daily max...

Label contents#

Full prescribing information#

Drug Fats

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient (in each caplet)

Calcium polycarbophil 625 mg

equivalent to 500 mg polycarbophil

OTC - PURPOSE SECTION

PURPOSE

Bulk-forming laxative

USES

INDICATIONS & USAGE SECTION

  • relieves occasional constipation to help restore and maintain regularity
  • this product generally produces bowel movement in 12 to 72 hours

WARNINGS SECTION

Choking Warning: Taking this product without adequate fluid may cause it to swell and block your throat or esophagus and may cause choking. Do not take this product if you have difficulty in swallowing. If you experience chest pain, vomiting, or difficulty in swallowing or breathing after taking this product, seek immediate medical attention.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • abdominal pain, nausea, or vomiting
  • a sudden change in bowel habits that persists over a period of 2 weeks

Ask your doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking any other drug. Take this product 2 or more hours before or after other drugs. All laxatives may affect how other drugs work.

When using this product

OTC - WHEN USING SECTION

  • do not use for more than 7 days unless directed by a doctor
  • do not take more than 8 tablets in a 24 hour period unless directed by a doctor

Stop use and ask a doctor if

OTC - STOP USE SECTION

rectal bleeding occurs or if you fail to have a bowel movement after use of this or any other laxative. These could be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSAGE SECTION

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • Take each dose of this product with at least 8 ounces (a full glass) of water or other fluid. Taking this product without enough liquid may cause choking. (See choking warning).
  • This product works naturally so continued use for one to three days is normally required to provide full benefit. Dosage may vary according to diet, exercise, previous laxative use or severity of constipation.

Age

Recommended

Daily maximum

adults & children 12 years of age and over

2 caplets once a day

up to 4 times a day

children under 12 years

consult a physician

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

  • each caplet contains: calcium 125 mg
  • store at room temperature
  • protect contents from moisture

Safety sealed: Do not use if imprinted safety seal under cap is broken or missing

INACTIVE INGREDIENT SECTION

calcium carbonate, caramel color, crospovidone, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, , polyethylene glycol, silicon dioxide, sodium lauryl sulfate.

Questions or Comments?

OTC - QUESTIONS SECTION

1-866-467-2748

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC# 68016-220-25

Premier Value®

COMPARE TO THE ACTIVE INGREDIENTS FIBERCON® CAPLETS*

Fiber Caplets

Calcium Polycarbophil 625 mg

Bulk-Forming

Fiber Laxative

  • Gentle Relief of Constipation
  • Won’t Cause Gas or Bloating
  • Effective as Fiber Powders

250 CAPLETS

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

Distributed By:

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue,

Wayne, PA 19087

*This product is not manufactured or distributed by Pfizer Inc., owner of the registered trademark Fibercon® Caplets

Premier Value Fiber Caplets 250 counts
Premier Value Fiber Caplets 250 counts

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308934calcium polycarbophil 625 MG Oral TabletPSN6
308934calcium polycarbophil 625 MG Oral TabletSCD6
308934calcium polycarbophil 625 MG (as polycarbophil 500 MG) Oral TabletSY6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-220-25Premier Value250 in 1 BOTTLETABLET, FILM COATED2506

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-220PREMIER VALUE (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [PHARMACY VALUE ALLIANCE, LLC]6Current NDC, Legacy NDC, 1 package rows20241030_4d766548-00d0-41bd-bb58-b69e037c77e2.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
68016-22068016-220-25

Ingredients#

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

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

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 ValueCALCIUM POLYCARBOPHILPHARMACY VALUE ALLIANCE, LLC4d766548-00d0-41bd-bb58-b69e037c77e22024-10-28WarningsExact identifier
ndc (package): 68016-220-25
ndc (product): 68016-220
ndc11 (package): 68016022025
spl id: 4750bfce-9afe-4bc0-b533-a2a30f263255
spl set id: 4d766548-00d0-41bd-bb58-b69e037c77e2

Reported adverse events (FAERS/openFDA)#

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