Fiber Laxative

Manufacturer
Safeway | Guardian Drug Company
Effective date
2016-01-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:44:42

Label at a glance#

ProductFiber Laxative
Active ingredientCALCIUM POLYCARBOPHIL
Label structure8 sections

Indications and uses

relieves occasional constipation this product generally produces bowel movement in 12 to 72 hours

Dosage and administration

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

Storage and handling

each caplet contains: calcium 135mg do not use if printed seal under cap is torn or missing 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

uses

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 a 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 overdose, 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 of water (8 oz.) or other fluid. Taking this product without enough liquid may cause choking. See choking warning.
  • dosage will vary according to diet, excercise, previous laxative use or severity of constipation.
  • continued use for 1 or 3 days is normally required to provide full benefit.
 adults and children 12 years and over                                                                  2 caplets, 1 to 4 times a day                                            
 Children under 12 years  ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • each caplet contains: calcium 135mg
  • do not use if printed seal under cap is torn or missing
  • 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

PDP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compate to Fibercon active ingredient

Fiber Laxative

Calcium Polycarbophil 625mg

Fiber therapy for regularity

As effective as fiber powders

Bluk forming laxatives

140 caplets

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308934calcium polycarbophil 625 MG Oral TabletPSN1
308934calcium polycarbophil 625 MG Oral TabletSCD1
308934calcium polycarbophil 625 MG (as polycarbophil 500 MG) Oral TabletSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21130-147-272020-01-31C16284748780-19d75b9d0-acea-f424-e053-dadaa90a57ceFiber Laxative
21130-147-942020-01-31C16284748780-19d75b9d0-acea-f424-e053-dadaa90a57ceFiber Laxative

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21130-147-27Fiber Laxative90 in 1 BOTTLETABLET901
21130-147-94Fiber Laxative140 in 1 BOTTLETABLET1401

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-147FIBER LAXATIVE (CALCIUM POLYCARBOPHIL) TABLET [SAFEWAY]1Legacy NDC, 2 package rows20160123_507d1e11-4343-48b1-815d-2e8dd219fd9b.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
21130-14721130-147-94, 21130-147-27

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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
9f23e74c-875b-4344-8c90-34511a4d5e85507d1e11-4343-48b1-815d-2e8dd219fd9b2016-01-21WarningsExact identifier
spl id: 9f23e74c-875b-4344-8c90-34511a4d5e85
spl set id: 507d1e11-4343-48b1-815d-2e8dd219fd9b

Reported adverse events (FAERS/openFDA)#

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