Fiber Laxative

Manufacturer
Geri-Care Pharmaceutical Corp
Effective date
2025-04-07
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:58:45

Label at a glance#

ProductFiber Laxative
Active ingredientCALCIUM POLYCARBOPHIL
Label structure8 sections

Indications and uses

relieves occasional constipation promotes regularity this product generally produces a 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 laxative 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. adults and children 12 years o...

Storage and handling

• each caplet contains: calcium 140 mg • store at controlled room temperature, 68°F-77°F (20°C-25°C) • protect contents from moisture Tamper Evident: Do not use if imprinted seal under cap is missing or broken.

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
  • promotes regularity
  • this product generally produces a 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 a doctor before use if you have

• abdominal pain, nausea, or vomiting

• a sudden change in bowel habits that persists over a period of 2 weeks.

Ask a doctor or pharmacist before use if 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

  • 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 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. In case of overdose, get medical help or contact a Poison Control Center right away.

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 laxative 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.
adults and children 12
years of age and older
Starting dose: 2 caplets once a day
Maximum dose: 2 caplets four times a day or as directed by a doctor
children under 12 years of ageconsult a doctor

Other information

STORAGE AND HANDLING SECTION

• each caplet contains: calcium 140 mg

• store at controlled room temperature, 68°F-77°F (20°C-25°C)

• protect contents from moisture

Tamper Evident: Do not use if imprinted seal under cap is missing or broken.

Inactive ingredients

INACTIVE INGREDIENT SECTION

caramel, cellulose, crospovidone, hypromellose,
magnesium silicate, magnesium stearate, mineral oil, PEG, silica, sodium
lauryl sulfate, stearic acid

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308934calcium polycarbophil 625 MG Oral TabletPSN8
308934calcium polycarbophil 625 MG Oral TabletSCD8
308934calcium polycarbophil 625 MG (as polycarbophil 500 MG) Oral TabletSY8

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57896-459-09Fiber Laxative90 in 1 BOTTLETABLET, FILM COATED908
57896-459-50Fiber Laxative500 in 1 BOTTLETABLET, FILM COATED5008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57896-459FIBER LAXATIVE (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [GERI-CARE PHARMACEUTICAL CORP]8Current NDC, Legacy NDC, 2 package rows20250409_616b4399-7626-5e59-e053-2a91aa0a0f75.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-459-09EA - Each57896-459ea49af8f-7117-439f-ac76-9b1b43c4432112019-09-05
57896-459-50EA - Each57896-45985a2e057-cb37-4f7a-b0ec-0aa287efd88312025-06-13

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57896-45957896-459-09, 57896-459-50

Ingredients#

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

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

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
Fiber LaxativeCALCIUM POLYCARBOPHILGeri-Care Pharmaceutical Corp616b4399-7626-5e59-e053-2a91aa0a0f752025-04-07WarningsExact identifier
ndc (package): 57896-459-09
ndc (package): 57896-459-50
ndc (product): 57896-459
ndc11 (package): 57896045909
ndc11 (package): 57896045950
spl id: 3234b1bc-797e-1383-e063-6394a90a7875
spl set id: 616b4399-7626-5e59-e053-2a91aa0a0f75

Reported adverse events (FAERS/openFDA)#

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