Premier Value Fiber Laxative

Manufacturer
Chain Drug Consortium
Effective date
2021-10-12
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:42:42

Label at a glance#

ProductPremier Value Fiber Laxative
Active ingredientCALCIUM POLYCARBOPHIL
Label structure8 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 dose   d...

Storage and handling

• each caplet contains : calcium 125 mg • do not use if printed seal under cap is torn or missing • store at 20-25°C (68-77°F) • protect contents from moisture

Label contents#

Full prescribing information#

Active ingredient (in each caplet )

OTC - ACTIVE INGREDIENT SECTION

Calcium polycarbophil 625 mg equivalent to 500 mg polycarbophil

Purpose

OTC - PURPOSE SECTION

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

WARNINGS SECTION

Choking: 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 your 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

OTC - ASK DOCTOR/PHARMACIST SECTION

you are 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 caplets 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.

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 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
  1. age
  1. recommended dose
  1. daily maximum
  1. adults & children 12 years of age and over
  1. 2 caplets once a day
  1. up to 4 times a day
  1. children under 12 years
  1. consult a physician

Other information

STORAGE AND HANDLING SECTION

  • each caplet contains: calcium 125 mg
  • do not use if printed seal under cap is torn or missing
  • store at 20-25°C (68-77°F)
  • protect contents from moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68016-259-00

Premier Value

Fiber Caplets

FIBER LAXATIVE

Calcium Polycarbophil 625 mg

  • Relieves constipation
  • Restores regularity
  • Daily source of fiber

COMPARE TO FIBERCON® ACTIVE INGREDIENT

90 CAPLETS

This product is not manufactured or distributed by Pfizer Consumer Healthcare, the distributor of FIBERCON®

Distributed by:

Chain Drug Consortium LLC.

3301 N.W. Boca Raton Blvd.

Suite 101, Boca Raton FL 33431

Fiber Laxative Label Premier Value Fiber Caplets 90ctPremier Value Fiber Caplets 90ct

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308934calcium polycarbophil 625 MG Oral TabletPSN4
308934calcium polycarbophil 625 MG Oral TabletSCD4
308934calcium polycarbophil 625 MG (as polycarbophil 500 MG) Oral TabletSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68016-259-002023-01-30C16284748780-1f386c649-d341-0266-e053-dadaa90a7c1aPremier Value Fiber Caplets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-259-00Premier Value Fiber Laxative90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-259PREMIER VALUE FIBER LAXATIVE (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM]4Legacy NDC, 1 package rows20211013_8de82f05-ef1e-45a6-bd67-d910bbe17e7f.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
68016-25968016-259-00

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
912ef635-ff00-45d7-9640-050286fdb9908de82f05-ef1e-45a6-bd67-d910bbe17e7f2021-10-12WarningsExact identifier
spl id: 912ef635-ff00-45d7-9640-050286fdb990
spl set id: 8de82f05-ef1e-45a6-bd67-d910bbe17e7f

Reported adverse events (FAERS/openFDA)#

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