FDA.reportPublic FDA data

Fiber Lax

Manufacturer
PD-Rx Pharmaceuticals, Inc.
Effective date
2025-10-20
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 01:39:37

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

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each captab)

Calcium polycarbophil 625 mg

Purpose

OTC - PURPOSE SECTION

Bulk-Forming Laxative

(equivalent to polycarbophil 500 mg)

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 medical attention.

Do not use

OTC - DO NOT USE SECTION

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 you are

OTC - ASK DOCTOR/PHARMACIST SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions

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.

  • do not take more than 4 doses in 24 hours
  • adults & children 12 years and over: 2 captabs 1 to 4 times a day
  • children under 12 years: ask a doctor

Other information

  • each captab contains: calcium 140 mg
  • store below 30˚C (86˚F) • do not refrigerate • protect from humidity

Inactive ingredients

INACTIVE INGREDIENT SECTION

Caramel, crospovidone, hypromellose, magnesium silicate, magnesium stearate, microcrystalline cellulose, mineral oil, polyethylene glycol, silica, sodium lauryl sulfate and stearic acid

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-645-2158

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF BLISTER SEAL IS BROKEN OR DAMAGED

*Rugby Laboratories, Inc. is not affiliated with the owner of the trademark FiberCon®.

Distributed by: Rugby Laboratories

17177 N Laurel Park Drive, Suite 233

Livonia, MI 48152

www. Rugbylaboratories.com

16 HOW SUPPLIED

HOW SUPPLIED SECTION

Fiber-Lax Tablets are available as follows:

500 mg: Off White, oval, scored tablet, debossed “CPC 339”. Available in bottles of

30 captabs (NDC 55289-949-30)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fiber-Lax

55289949 Label55289949 Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308934calcium polycarbophil 625 MG Oral TabletPSN10
308934calcium polycarbophil 625 MG Oral TabletSCD10
308934calcium polycarbophil 625 MG (as polycarbophil 500 MG) Oral TabletSY10

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeData Matrix(01)00355289949305(21)K20C890005(17)221130(10)K20C89GTIN-14: 00355289949305
GTIN-12: 355289949305
UPC-A: 355289949305
EAN-13: 0355289949305
GTIN storage (14 digits): 00355289949305		55289949.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55289-949-30Fiber Lax30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55289-949-30EA - Each55289-949711edde9-8542-46ff-a55e-a83260f0394c12021-04-08
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

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
55289-94955289-949-30
0536-4306

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
CARAMELT9D99G2B1RIACT
CROSPOVIDONE, UNSPECIFIED2S7830E561IACT
HYPROMELLOSES3NXW29V3WOIACT
TALC7SEV7J4R1UIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
LIGHT MINERAL OILN6K5787QVPIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM LAURYL SULFATE368GB5141JIACT
STEARIC ACID4ELV7Z65APIACT
CALCIUM POLYCARBOPHIL8F049NKY49ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
92024-10-10full-release2026-06-01 00:24:15

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
Fiber LaxCALCIUM POLYCARBOPHILPD-Rx Pharmaceuticals, Inc.730198a5-b6d9-4fc7-b053-a7c65a93c5402025-10-20WarningsExact identifier
ndc (package): 55289-949-30
ndc (product): 55289-949
ndc11 (package): 55289094930
spl id: 419b8a9a-2ee8-ef30-e063-6294a90a3e94
spl set id: 730198a5-b6d9-4fc7-b053-a7c65a93c540

Reported adverse events (FAERS/openFDA)#

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