FDA.reportPublic FDA data

Fiber Laxative Calcium Polycarbophil

Manufacturer
Magno-Humphries, Inc.
Effective date
2017-12-21
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-02 01:06:04

Label at a glance#

ProductFiber Laxative Calcium Polycarbophil
Active ingredientCALCIUM POLYCARBOPHIL
Label structure12 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 at least 8 ounces (a full glass) of water or other fluid. Taking this product without enough liquid may cause choking. See chokin warning. ​Adults and children over 12 years: ​2 tablets once a day up to 4 times a day.  ​Children under 12 years: ​ ask a doctor

Label contents#

Full prescribing information#

MHL NDC 54257-790-07

SPL UNCLASSIFIED SECTION

Compare to the active ingredient in Fibercon®*

FIBER LAXATIVE CALCIUM POLYCARBOPHIL

SPL UNCLASSIFIED SECTION

  • RELIEVES CONSTIPATION
  • 280g of CALCIUM PER DOSE
  • GENTLE ENOUGH TO USE EVERDAY

90 TABLETS

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

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, vomitting, 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 tablets 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.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take this product (child or adult dose) with at least 8 ounces (a full glass) of water or other fluid. Taking this product without enough liquid may cause choking. See chokin warning.

​Adults and children over 12 years: ​2 tablets once a day up to 4 times a day.  ​Children under 12 years:​ ask a doctor

Other information

SPL UNCLASSIFIED SECTION

  • ​each tablet contains:​ 140 mg calcium
  • store at 20° to 25°C (68° to 77°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, stearic acid.

Questions?

OTC - QUESTIONS SECTION

call toll-free 1-800-935-6737

*This product is not manufactured or distributed by the owener of the registered trademark Fibercon® Distributed by: Magno-Humphries, Inc., OR 97223 U.S.A. ​Visit our website: www.magno-humphries.com

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by the owener of the registered trademark Fibercon®

Distributed by: ​Magno-Humphries, Inc., OR 97223 U.S.A.

​Visit our website: www.magno-humphries.com

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Drug FactsDrug Facts

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
54257-79054257-790-07

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
CARAMELT9D99G2B1RIACT
CROSPOVIDONE, UNSPECIFIED2S7830E561IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM SILICATE9B9691B2N9IACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
MINERAL OILT5L8T28FGPIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM LAURYL SULFATE368GB5141JIACT
STEARIC ACID4ELV7Z65APIACT
CALCIUM POLYCARBOPHIL8F049NKY49ACTIB

Source Document#

Source XML · Source PDF

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
b4f213be-1ebc-bd14-e053-2995a90a5f29f7854733-904a-4c2c-bcc2-0fcc1babdf1e2020-11-25WarningsExact identifier
spl set id: f7854733-904a-4c2c-bcc2-0fcc1babdf1e

Reported adverse events (FAERS/openFDA)#

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