Fiber Lax

Manufacturer
Contract Pharmacy Services-PA
Effective date
2010-07-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:25:29

Label at a glance#

ProductFiber Lax
Active ingredientCALCIUM POLYCARBOPHIL
Label structure10 sections

Indications and uses

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

Dosage and administration

Take Fiber-Lax 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. -take dose 1-4 times daily - do not take more than 4 doses in 24 hours. -adults & children 12 years and over: 2 captabs -children under 12 years: ask a doctor

Storage and handling

-store below 30 degrees C (86 degrees F) -do not refrigerate -protect from humidity

Label contents#

Full prescribing information#

ACTIVE INGREDIENT (IN EACH TABLET)

OTC - ACTIVE INGREDIENT SECTION

Calcium Polycarbophil 625mg (equivalent to polycarbophil 500mg)

PURPOSE

OTC - PURPOSE SECTION

Bulk-Forming Laxative

USES

INDICATIONS & USAGE SECTION

- relieves occasional constipation

- 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 attention.

Do not use

OTC - DO NOT USE SECTION

for longer than one week

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

-abdominal pain, nausea, or vomiting

-noticed a sudden change in bowel habits that lasts over two weeks

Ask a doctor or pharmacist before use if

OTC - ASK DOCTOR/PHARMACIST SECTION

you are taking any other drug. Take Fiber-Lax two or more hours before or after other drugs. Laxatives may affect how other drugs work.

Stop use and ask a doctor if

OTC - STOP USE SECTION

-you have rectal bleeding

-you fail to have a bowel movement after using this product. These may indicate a serious condition.

Keep out of reach of children.

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 Center right away.

DIRECTIONS

SPL UNCLASSIFIED SECTION

Take Fiber-Lax 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.

-take dose 1-4 times daily - do not take more than 4 doses in 24 hours.

-adults & children 12 years and over: 2 captabs

-children under 12 years: ask a doctor

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

each captab contains: calcium 140mg

STORAGE

STORAGE AND HANDLING SECTION

-store below 30 degrees C (86 degrees F)

-do not refrigerate

-protect from humidity

INACTIVE INGREDIENTS

SPL UNCLASSIFIED SECTION

Anhydrous lactose, caramel powder, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium lauryl and stearic acid.

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

Questions and Comments?

Call 1-800-645-2158, 9am - 5pm ET, Monday - Friday

Repackaged by:

Contract Pharmacy Services-PA
125 Titus Ave Suite 200
Warrington, PA 18976 USA

Original--08/2010--NJW

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Blister of 30
Blister of 30

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

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CALCIUM Pharmacologic Class Indexing3Indexing - Pharmacologic Class20230427

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67046-205-302019-10-21C16284748780-1956f9ecf-df74-621f-e053-dbdaa90a74adFiber-Lax

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-205-30Fiber Lax30 in 1 BLISTER PACKTABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-205FIBER LAX TABLET [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 1 package rows20100809_e1e31142-4256-4b12-8d2b-29a6cf45dc91.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-4306-05EA - Each0536-4306463c1279-6853-4f79-912a-8572fd9cc5cb12012-07-24
0536-4306-08EA - Each0536-43060195b521-a1e1-41ec-8d0b-23b27de41bb112012-07-24
0536-4306-11EA - Each0536-43068919242e-6c8d-4c4a-83bc-af8ed23ccb9612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CALCIUM POLYCARBOPHILACTIVE INGREDIENT8F049NKY491
CALCIUMACTIVE MOIETYSY7Q814VUP1

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67046-20567046-205-30
0536-4306

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
CALCIUM POLYCARBOPHIL8F049NKY49ACTIB

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fiber LaxCALCIUM POLYCARBOPHILRugby Laboratories318d81ed-0b06-4d21-8b97-2d1f0267c7812025-12-02WarningsExact identifier
ndc (product): 0536-4306
e1e31142-4256-4b12-8d2b-29a6cf45dc91e1e31142-4256-4b12-8d2b-29a6cf45dc912010-07-30WarningsExact identifier
spl id: e1e31142-4256-4b12-8d2b-29a6cf45dc91
spl set id: e1e31142-4256-4b12-8d2b-29a6cf45dc91

Reported adverse events (FAERS/openFDA)#

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