FDA.reportPublic FDA data

Fibercon

Manufacturer
Foundation Consumer Brands
Effective date
2026-03-12
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:50:09

Label at a glance#

ProductFibercon
Active ingredientCALCIUM POLYCARBOPHIL
Label structure11 sections

Indications and uses

relieves occasional constipation (irregularity) this product generally produces bowel movement in 12 to 72 hours

Dosage and administration

take each dose of this product 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. FiberCon 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 12 years of age...

Storage and handling

each caplet contains: 140 mg calcium and 10 mg magnesium protect contents from moisture store at 20-25°C (68-77°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

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 (irregularity)
  • this product generally produces bowel movement in 12 to 72 hours

Warnings

WARNINGS SECTION

Choking

SPL UNCLASSIFIED 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.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you aretaking any other drug. Take this product 2 or more hours before or after other drugs. All laxatives may affect how other drugs work.

OTC - WHEN USING SECTION

When using this productdo not use for more than 7 days unless directed by a doctor

OTC - STOP USE SECTION

Stop use and ask a doctor ifrectal 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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take each dose of this product with at least 8 ounces (a full glass) of water or other fluid. Taking this product without enough liquid may cause choking. See chokingwarning.
  • FiberCon 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 12 years of age and over: 2 caplets per dose. Do not take more than 8 caplets in 24 hours unless directed by a doctor.
  • children under 12 years of age: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • each caplet contains:140 mg calcium and 10 mg magnesium
  • protect contents from moisture
  • store at 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

caramel, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, polyethylene glycol, silicon dioxide, sodium lauryl sulfate, stearic acid

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-888-594-0677weekdays 9 AM to 5 PM EST

SPL UNCLASSIFIED SECTION

Distributed by: Foundation Consumer Brands, LLC
Pittsburgh, PA 15212

WARNING: Reproductive Harm - www.P65warnings.ca.gov

PRINCIPAL DISPLAY PANEL - 140 Caplet Bottle

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FiberCon ®

Calcium Polycarbophil
Bulk-Forming Laxative

Simple Relief for Constipation

  • Won't cause gas or bloating
  • As effective as fiber powders

140 Coated Caplets

PDPPDP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308934calcium polycarbophil 625 MG Oral TabletPSN4
210665FiberCon 625 MG Oral TabletPSN4
210665calcium polycarbophil 625 MG Oral Tablet [FiberCon]SBD4
308934calcium polycarbophil 625 MG Oral TabletSCD4
308934calcium polycarbophil 625 MG (as polycarbophil 500 MG) Oral TabletSY4
210665FiberCon (calcium polycarbophil 625 MG) Oral TabletSY4
210665FiberCon 625 MG Oral TabletSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80070-500-14Fibercon140 in 1 BOTTLETABLET1404
80070-500-28Fibercon280 in 1 BOTTLETABLET2804

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
80070-50080070-500-14, 80070-500-28

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
CARAMELT9D99G2B1RIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
CROSPOVIDONE (120 .MU.M)68401960MKIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM LAURYL SULFATE368GB5141JIACT
CALCIUM POLYCARBOPHIL8F049NKY49ACTIB
STEARIC ACID4ELV7Z65APIACT
MINERAL OILT5L8T28FGPIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32025-10-24monthly-update2026-06-03 17:38:16
22024-09-01full-release2026-06-01 00:16:41

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
FiberconCALCIUM POLYCARBOPHILFoundation Consumer Brands7992a4bb-5535-4a1d-867d-a99f7e0c1be72026-03-12WarningsExact identifier
ndc (package): 80070-500-14
ndc (package): 80070-500-28
ndc (product): 80070-500
ndc11 (package): 80070050028
ndc11 (package): 80070050014
spl id: 4cd75c27-5ebb-ba3c-e063-6394a90a1e84
spl set id: 7992a4bb-5535-4a1d-867d-a99f7e0c1be7

Reported adverse events (FAERS/openFDA)#

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