FDA.reportPublic FDA data

Fiber Lax

Manufacturer
Bryant Ranch Prepack
Effective date
2014-06-13
Label type
HUMAN OTC DRUG LABEL
Version
1001
Source
legacy-cache
Hydrated at
2026-08-02 01:35:59

Label at a glance#

ProductFiber Lax
Active ingredientCALCIUM POLYCARBOPHIL
Label structure13 sections

Indications and uses

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

(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.

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 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?

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

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®.

Fiber-Lax is distributed by Rugby Laboratories, Inc.

Rugby®
Duluth, Georgia 30097
www. Rugbylaboratories.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fiber- Lax Polycarbo 500mg Tablet

Label
Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-4436-12021-08-18C16284748780-19855e2a2-3366-60a7-e053-dbdaa90a05bdFiber-Lax Calcium Polycarbophil
63629-4436-22021-08-18C16284748780-19855e2a2-3366-60a7-e053-dbdaa90a05bdFiber-Lax Calcium Polycarbophil
63629-4436-32021-08-18C16284748780-19855e2a2-3366-60a7-e053-dbdaa90a05bdFiber-Lax Calcium Polycarbophil
63629-4436-12019-11-27C16284748780-19855e2a2-3366-60a7-e053-dbdaa90a05bdFiber-Lax Calcium Polycarbophil
63629-4436-22019-11-27C16284748780-19855e2a2-3366-60a7-e053-dbdaa90a05bdFiber-Lax Calcium Polycarbophil
63629-4436-32019-11-27C16284748780-19855e2a2-3366-60a7-e053-dbdaa90a05bdFiber-Lax Calcium Polycarbophil

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 INGREDIENT8F049NKY491001
POLYCARBOPHILACTIVE MOIETYW25LM17A4W1001
CARAMELINACTIVE INGREDIENTT9D99G2B1R1001
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U1001
CROSPOVIDONEINACTIVE INGREDIENT68401960MK1001
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WO1001
MAGNESIUM SILICATEINACTIVE INGREDIENT9B9691B2N91001
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I301001
MINERAL OILINACTIVE INGREDIENTT5L8T28FGP1001
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1A1001
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU41001
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141J1001
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP1001

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
63629-443663629-4436-1, 63629-4436-2, 63629-4436-3
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
CALCIUM POLYCARBOPHIL8F049NKY49ACTIB
CARAMELT9D99G2B1RIACT
CROSPOVIDONE68401960MKIACT
HYPROMELLOSES3NXW29V3WOIACT
MAGNESIUM SILICATE9B9691B2N9IACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
MINERAL OILT5L8T28FGPIACT
POLYETHYLENE GLYCOLS3WJQ0SDW1AIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM LAURYL SULFATE368GB5141JIACT
STEARIC ACID4ELV7Z65APIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 14 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CARAMELCARAMELT9D99G2B1RCAPSULE / ORALNAExact identifier — unii+route
6 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FILM COATED / ORAL166 mgExact identifier — unii+route+dosage form
CARAMELCARAMELT9D99G2B1RSUSPENSION / ORAL111.12 mg/5mlExact identifier — unii+route
6 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RSYRUP / ORAL207 mg/5mlExact identifier — unii+route
6 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, FILM COATED / ORAL176 mgExact identifier — unii+route+dosage form
CARAMELCARAMELT9D99G2B1RLIQUID / ORAL5.3 mgExact identifier — unii+route
6 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RGRANULE, FOR SUSPENSION / ORAL2.5 mg/5mlExact identifier — unii+route
6 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET, FILM COATED / ORAL240 mgExact identifier — unii+route+dosage form
MINERAL OILMINERAL OILT5L8T28FGPTABLET, FILM COATED / ORALNAExact identifier — unii+route+dosage form
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED / ORAL992 mgExact identifier — unii+route+dosage form
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED / ORAL96 mgExact identifier — unii+route+dosage form
CARAMELCARAMELT9D99G2B1RSOLUTION / ORAL11 mgExact identifier — unii+route
6 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED / ORAL582 mgExact identifier — unii+route+dosage form
MAGNESIUM SILICATEMAGNESIUM SILICATE9B9691B2N9TABLET, FILM COATED / ORAL33.7 mgExact identifier — unii+route+dosage form

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
a78ef53f-fddf-4a83-8ff6-d5429f3b4d1644ced43c-b5cb-49cb-a0cf-b3c54b342e232021-08-17WarningsExact identifier
spl set id: 44ced43c-b5cb-49cb-a0cf-b3c54b342e23

Reported adverse events (FAERS/openFDA)#

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