FDA.reportPublic FDA data

Fiber Laxative

Manufacturer
Magno-Humphries, Inc.
Effective date
2023-10-27
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:58:13

Label at a glance#

ProductFiber Laxative
Active ingredientCALCIUM POLYCARBOPHIL
Label structure8 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 2 tablets once a day up to 4 times a day adults and children 12 years of ...

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

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

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. Choking:

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • abdominal pain, nausea, or vomiting
  • difficulty in swallowing
  • a sudden change in bowel habits that persists over a period of 2 weeks

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - WHEN USING SECTION

  • do not use for more than 7 days unless directed by a doctor
  • do not take more than 8 tablets in a 24 hour period unless directed b y a doctor

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you experience chest pain, abdominal pain, nausea, vomiting, difficulty in breathing or swallowing
  • you fail to have a bowel movement after use or have rectal bleeding. These could be signs of 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 (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
  • 2 tablets once a day up to 4 times a day adults and children 12 years of age and over:
  • ask a doctor children under 12 years of age:

Other information

SPL UNCLASSIFIED SECTION

  • calcium 135 mg each tablet contains:
  • store at 20°-25°C (68°-77°F)
  • protect contents from moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

calcium carbonate, caramel, colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline  cellulose, polyethylene glycol, sodium lauryl sulfate.

Questions?

OTC - QUESTIONS SECTION

call toll-free 1-800-935-6737

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label3Label3

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308934calcium polycarbophil 625 MG Oral TabletPSN3
308934calcium polycarbophil 625 MG Oral TabletSCD3
308934calcium polycarbophil 625 MG (as polycarbophil 500 MG) Oral TabletSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54257-379-07Fiber Laxative90 in 1 BOTTLETABLET903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54257-379FIBER LAXATIVE (CALCIUM POLYCARBOPHIL) TABLET [MAGNO-HUMPHRIES, INC.]3Current NDC, Legacy NDC, 1 package rows20231030_9d22c208-d089-8b6a-e053-2995a90ab90a.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54257-37954257-379-07

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALCIUM CARBONATEH0G9379FGKIACT
CARAMELT9D99G2B1RIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CROSPOVIDONE2S7830E561IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
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.9d22c208-d089-8b6a-e053-2995a90ab90a2023-10-27WarningsExact identifier
ndc (package): 54257-379-07
ndc (product): 54257-379
ndc11 (package): 54257037907
spl id: 08bf29ff-1c8c-1547-e063-6294a90ac7ee
spl set id: 9d22c208-d089-8b6a-e053-2995a90ab90a

Reported adverse events (FAERS/openFDA)#

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