FDA.reportPublic FDA data

FIBER LAXATIVE CAPLETS

Manufacturer
Gendose Pharmaceuticals, LLC
Effective date
2024-01-08
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:12:00

Label at a glance#

ProductFIBER LAXATIVE CAPLETS
Active ingredientCALCIUM POLYCARBOPHIL
Label structure9 sections

Indications and uses

RELIEVES OCCASIONAL CONSTIPATION TO HELP RESTORE AND MAINTAIN REGULARITY THIS PRODUCT GENERALLY PRODUCES BOWEL MOVEMENT IN 12 TO 72 HOURS

Dosage and administration

TAKE EACH DOSE 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. THIS PRODUCT WORKS NATURALLY SO CONTINUED USE FOR ONE TO THREE DAYS IS NORMALLY REQUIRED TO PROVIDE FULL BENEFIT. DOSAGE MAY VARY ACCORDING TO DIET, EXERCISE, PREVIOUS LAXATIVE USE OR SEVERITY OF CONSTIPATION ADULTS AND CHILDREN OVER 12 YEARS: 2 CAPLETS ONC...

Storage and handling

EACH CAPLET CONTAINS: CALCIUM 125MG 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 TO HELP RESTORE AND MAINTAIN REGULARITY
  • 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 ESAPHAGUS AND MAY CAUSE CHOKING. DO NOT TAKE THIS PRODUCT IF YOU HAVE DIFFICULATY 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

  • ADBOMINAL PAIN, NAUSEA, OR VOMITING
  • A SUDDEN CHANGE IN BOWEL HABITS THAT PERSIST OVER A PERIOD OF 2 WEEKS

ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE TAKING ANY OTHER DRUG. TAKE THIS PRODUCT 2 OR MORE HOURS BEFORE OR AFTER OTHER DRUGS. ALL LAXATIVES MAY AFFECT HOW DRUGS WORK.

WHEN USING THIS PRODUCT

  • 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 RECTAL BLEEDING OCCURS OR IF YOU FAIL TO HAVE A BOWEL MOVEMENT AFTER USE OF THIS OR ANY OTHER LAXATIVES. THESE COULD BE SIGNS OF A SERIOUS CONDITION.

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 CONTROL CENTER RIGHT AWAY 1-800-222-1222.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • TAKE EACH DOSE 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.
  • THIS PRODUCT WORKS NATURALLY SO CONTINUED USE FOR ONE TO THREE DAYS IS NORMALLY REQUIRED TO PROVIDE FULL BENEFIT. DOSAGE MAY VARY ACCORDING TO DIET, EXERCISE, PREVIOUS LAXATIVE USE OR SEVERITY OF CONSTIPATION

ADULTS AND CHILDREN OVER 12 YEARS: 2 CAPLETS ONCE A DAY; UP TO 4 TIMES A DAY.

CHILDREN UNDER 12 YEARS: ASK A DOCTOR

OTHER INFORMATION

STORAGE AND HANDLING SECTION

  • EACH CAPLET CONTAINS: CALCIUM 125MG
  • STORE AT ROOM TEMPERATURE
  • PROTECT CONTENTS FROM MOISTURE

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

CALCIUM CARBONATE, CARAMEL COLOR, CROSPOVIDONE, HYPROMELLOSE, MAGNESIUM STEARATE, MALTODEXTRIN, MICROCRYSTALLINE CELLULOSE, POLYETHYLENE GLYCOL, SILICON DIOXIDE, SODIUM LAURYL SULFATE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b LBL_Fiber Laxative Caplets_50 caplets01b LBL_Fiber Laxative Caplets_50 caplets

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308934calcium polycarbophil 625 MG Oral TabletPSN6
308934calcium polycarbophil 625 MG Oral TabletSCD6
308934calcium polycarbophil 625 MG (as polycarbophil 500 MG) Oral TabletSY6

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77333-120-502024-05-02C16284748780-11030e365-38f1-111a-e063-dadaa90a10e2GENDOSE - FIBER LAXATIVE CAPLETS (77333-120)
77333-120-502024-01-30C16284748780-11030e365-38f1-111a-e063-dadaa90a10e2GENDOSE - FIBER LAXATIVE CAPLETS (77333-120)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77333-120-25FIBER LAXATIVE CAPLETS1 in 1 BLISTER PACKTABLET16
77333-120-50FIBER LAXATIVE CAPLETS50 in 1 BOXTABLET506

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77333-120FIBER LAXATIVE CAPLETS (CALCIUM POLYCARBOPHIL) TABLET [GENDOSE PHARMACEUTICALS, LLC]6Current NDC, Legacy NDC, 2 package rows20240504_e7f3b91b-7942-3e0d-e053-2a95a90a34ee.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
77333-120-25EA - Each77333-12000d2b681-b51d-4f79-8e75-ad6a2a4d7f2812022-10-06
77333-120-50EA - Each77333-120f371e8ef-063a-4465-aa81-4f518adc663f12022-10-06

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77333-12077333-120-25, 77333-120-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CALCIUM CARBONATEH0G9379FGKIACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
CROSPOVIDONE2S7830E561IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
CARAMELT9D99G2B1RIACT
CALCIUM POLYCARBOPHIL8F049NKY49ACTIB

Source Document#

Source XML

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
FIBER LAXATIVE CAPLETSCALCIUM POLYCARBOPHILGendose Pharmaceuticals, LLCe7f3b91b-7942-3e0d-e053-2a95a90a34ee2024-01-08WarningsExact identifier
ndc (package): 77333-120-25
ndc (package): 77333-120-50
ndc (product): 77333-120
ndc11 (package): 77333012050
ndc11 (package): 77333012025
spl id: 0e768c1f-3c9e-c128-e063-6294a90a4463
spl set id: e7f3b91b-7942-3e0d-e053-2a95a90a34ee

Reported adverse events (FAERS/openFDA)#

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