Fiber Lax

Manufacturer
NCS HealthCare of KY, Inc dba Vangard Labs
Effective date
2012-03-26
Label type
HUMAN OTC DRUG LABEL
Version
13
Source
legacy-cache
Hydrated at
2026-08-02 01:47:36

Label at a glance#

ProductFiber Lax
Active ingredientCALCIUM POLYCARBOPHIL
Label structure9 sections

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.  ∙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

Label contents#

Full prescribing information#

Active ingredient(in each captab)

OTC - ACTIVE INGREDIENT SECTION

Calcium polycarbophil 625mg

Purpose

OTC - PURPOSE SECTION

Bulk-Forming Laxative

(equivalent to polycarbophil 500mg)

Use(s)

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

 longer than one week

Ask a doctor before use if you have

WARNINGS 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

 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 Center right away.

Directions

DOSAGE & ADMINISTRATION 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.

 ∙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

SPL UNCLASSIFIED SECTION

∙each captab contains: calcium 140mg

∙store below 30⁰C (86⁰F) ∙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 and Comments?

OTC - QUESTIONS SECTION

Call 1-800-645-2158, 9am - 5pm 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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fiber-Lax Captabs

Principal Panel Display-Fiber-Lax Captabs
Principal Panel Display-Fiber-Lax Captabs

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0615-5532-312021-05-18C16284748780-197449f38-d532-f6ea-e053-dbdaa90aa703Drug Facts
0615-5532-392021-05-18C16284748780-197449f38-d532-f6ea-e053-dbdaa90aa703Drug Facts
0615-5532-312019-11-13C16284748780-197449f38-d532-f6ea-e053-dbdaa90aa703Drug Facts
0615-5532-392019-11-13C16284748780-197449f38-d532-f6ea-e053-dbdaa90aa703Drug Facts

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 INGREDIENT8F049NKY4913
POLYCARBOPHILACTIVE MOIETYW25LM17A4W13
CARAMELINACTIVE INGREDIENTT9D99G2B1R13
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U13
CROSPOVIDONEINACTIVE INGREDIENT68401960MK13
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WO13
MAGNESIUM SILICATEINACTIVE INGREDIENT9B9691B2N913
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I3013
MINERAL OILINACTIVE INGREDIENTT5L8T28FGP13
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1A13
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU413
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141J13
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP13

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
0615-55320615-5532-31, 0615-5532-39
0536-4306

Ingredients#

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

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

Source Document#

Source XML · Source PDF

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
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FILM COATED / ORAL166 mgExact identifier — unii+route+dosage form
MAGNESIUM SILICATEMAGNESIUM SILICATE9B9691B2N9TABLET, FILM COATED / ORAL33.7 mgExact identifier — unii+route+dosage form
CARAMELCARAMELT9D99G2B1RLIQUID / ORAL5.3 mgExact identifier — unii+route
6 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, FILM COATED / ORALNAExact identifier — unii+route+dosage form
CARAMELCARAMELT9D99G2B1RSOLUTION / ORAL11 mgExact identifier — unii+route
6 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RCAPSULE / ORALNAExact identifier — unii+route
6 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED / ORAL96 mgExact identifier — unii+route+dosage form
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED / ORAL582 mgExact identifier — unii+route+dosage form
CARAMELCARAMELT9D99G2B1RSUSPENSION / ORAL111.12 mg/5mlExact 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
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED / ORAL992 mgExact identifier — unii+route+dosage form
CARAMELCARAMELT9D99G2B1RSYRUP / ORAL207 mg/5mlExact identifier — unii+route
6 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, FILM COATED / ORAL176 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
2d72f560-cb58-4397-84ab-2aae7ac22229a36eb503-f6be-4b9f-be33-0424a3d3f3e32021-05-14WarningsExact identifier
spl set id: a36eb503-f6be-4b9f-be33-0424a3d3f3e3

Reported adverse events (FAERS/openFDA)#

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