FDA.reportPublic FDA data

Fiber Laxative

Manufacturer
Topco Associates, LLC | Guardian Drug Company
Effective date
2025-01-20
Label type
Human OTC Drug Label
Version
3
Source
full-release
Hydrated at
2026-06-01 00:53:12

Label at a glance#

ProductFiber Laxative
Active ingredientCALCIUM POLYCARBOPHIL
Label structure13 sections

Dosage and administration

take this product (child or adult dose)  with a full glass or water (8oz.) or other fluid. Taking this product without enough liquid may cause chocking. See choking warning. dosage will vary according to diet, exercise, previous laxative use or severity of constipation continued use for 1 to 3 days is normally required to provide full benefit adults and children 12 years and over 2 caplets, 1 to 4 times a day   ch...

Storage and handling

each caplet contains: calcium 135 mg store at room temperature 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

USE(S)

INDICATIONS & USAGE SECTION

  • relieves occasional constipation
  • 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 A DOCTOR BEFORE USE IF YOU HAVE

OTC - ASK DOCTOR SECTION

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

ASK A 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 caplets in a 24 hour period unless directed by a  doctor

STOP USE AND ASK DOCTOR IF

OTC - STOP USE SECTION

  • you experience chest pain, abdominal pain, nausea, vomiting, difficulty in breathing or swallowing
  • you fail to have a bowel movement after use or have rectal bleeding.

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 over dose, get medical help or contact a Poison Control Center immediately.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • take this product (child or adult dose)  with a full glass or water (8oz.) or other fluid. Taking this product without enough liquid may cause chocking. See choking warning.
  • dosage will vary according to diet, exercise, previous laxative use or severity of constipation
  • continued use for 1 to 3 days is normally required to provide full benefit

adults and children 12 years and over2 caplets, 1 to 4 times a day 
 children under 12 years  ask a doctor







OTHER INFORMATION

STORAGE AND HANDLING SECTION

  • each caplet contains: calcium 135 mg
  • store at room temperature
  • protect contents from moisture

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

calcium carbonate, caramel, colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 36800-465-27
Topcare`     
COMPARE TO FIBERCON ACTIVE INGREDIENT
Fiber Laxative

CALCIUM POLYCARBOPHIL 625 mg

BULK-FORMING LAXATIVE

  • Gentle Enough for Everyday Use
  • Just as Effective as Fiber Powders

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

8181

8181

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308934calcium polycarbophil 625 MG Oral TabletPSN3
308934calcium polycarbophil 625 MG Oral TabletSCD3
308934calcium polycarbophil 625 MG (as polycarbophil 500 MG) Oral TabletSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-465-27Fiber Laxative90 in 1 BOTTLETABLET903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-465FIBER LAXATIVE (CALCIUM POLYCARBOPHIL) TABLET [TOPCO ASSOCIATES, LLC]3Current NDC, Legacy NDC, 1 package rows20250121_0609468d-ee66-49af-be40-e51965b88f6f.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
36800-46536800-465-27

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALCIUM POLYCARBOPHIL8F049NKY49ACTIB
CALCIUM CARBONATEH0G9379FGKIACT
CARAMELT9D99G2B1RIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CROSPOVIDONE, UNSPECIFIED2S7830E561IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
SODIUM LAURYL SULFATE368GB5141JIACT

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
Fiber LaxativeCALCIUM POLYCARBOPHILTopco Associates, LLC0609468d-ee66-49af-be40-e51965b88f6f2025-01-20WarningsExact identifier
ndc (package): 36800-465-27
ndc (product): 36800-465
ndc11 (package): 36800046527
spl id: 821bab17-7641-48eb-b46f-d23c98d30a2d
spl set id: 0609468d-ee66-49af-be40-e51965b88f6f

Reported adverse events (FAERS/openFDA)#

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