FDA.reportPublic FDA data

FIBER LAXATIVE

Manufacturer
Magno-Humphries, Inc.
Effective date
2024-01-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:06:34

Label at a glance#

ProductFIBER LAXATIVE
Active ingredientCALCIUM POLYCARBOPHIL
Label structure10 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 this product (child or adult dose) with a full glass of water (8 oz.) or other fluid. Taking this product without enough liquid may cause choking. See choking warning. dosage will vary according to diet, exercise, previous laxative use or severity of constipation continued use for 1 to 3 days is normally required to provide full benefit adults and children 12 years of age and over: 2 caplets once a day up to ...

Storage and handling

each caplet contains: calcium 125 mg store at 20°-25°C (68°-77°F) 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 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.

Ask a doctor before use if you have

  • abdominal pain, nausea, or vomiting
  • a sudden change in bowel habits that persists 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 other 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 laxative. 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 (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take this product (child or adult dose) with a full glass of water (8 oz.) or other fluid. Taking this product without enough liquid may

cause choking. See choking warning.

  • dosage will vary according to diet, exercise, previous laxative use or severity of constipation
  • continued use for 1 to 3 days is normally required to provide full benefit
  • adults and children 12 years of age and over: 2 caplets once a day up to 4 times a day
  • children under 12 years of age: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • each caplet contains: calcium 125 mg
  • store at 20°-25°C (68°-77°F)
  • 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.

Questions?

OTC - QUESTIONS SECTION

call toll-free 1-800-935-6737

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b LBL (PDP)_MH_ Fiber Laxative_90cap01b LBL (PDP)_MH_ Fiber Laxative_90cap

01b LBL (DF1)_MH_ Fiber Laxative01b LBL (DF1)_MH_ Fiber Laxative

01b LBL (DF2)_MH_ Fiber Laxative01b LBL (DF2)_MH_ Fiber Laxative

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308934calcium polycarbophil 625 MG Oral TabletPSN2
308934calcium polycarbophil 625 MG Oral TabletSCD2
308934calcium polycarbophil 625 MG (as polycarbophil 500 MG) Oral TabletSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54257-479-07FIBER LAXATIVE90 in 1 BOTTLETABLET902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54257-479FIBER LAXATIVE (CALCIUM POLYCARBOPHIL) TABLET [MAGNO-HUMPHRIES, INC.]2Current NDC, Legacy NDC, 1 package rows20240104_e4a921c5-1cf7-12ca-e053-2a95a90a6e04.zip

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
54257-47954257-479-07

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
CALCIUM CARBONATEH0G9379FGKIACT
CROSPOVIDONE2S7830E561IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
CARAMELT9D99G2B1RIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM LAURYL SULFATE368GB5141JIACT
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 LAXATIVECALCIUM POLYCARBOPHILMagno-Humphries, Inc.e4a921c5-1cf7-12ca-e053-2a95a90a6e042024-01-03WarningsExact identifier
ndc (package): 54257-479-07
ndc (product): 54257-479
ndc11 (package): 54257047907
spl id: 0e12b04e-2bdf-0a8b-e063-6294a90a3d47
spl set id: e4a921c5-1cf7-12ca-e053-2a95a90a6e04

Reported adverse events (FAERS/openFDA)#

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