FDA.reportPublic FDA data

Calcium Polycarbophil

Manufacturer
LEADER/ Cardinal Health 110, Inc.
Effective date
2025-11-06
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:42:42

Label at a glance#

ProductCalcium Polycarbophil
Active ingredientCALCIUM POLYCARBOPHIL
Label structure10 sections

Indications and uses

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

Dosage and administration

take each dose of this product with a full glass of water (8oz.) 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, 1 to 4 times per day chi...

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each caplet)

Calcium polycarbophil 625 mg (equivalent to polycarbophil 500 mg)

OTC - PURPOSE SECTION

Purpose

Bulk-forming laxative

Uses

INDICATIONS & USAGE SECTION

relieves occasional constipation (irregularity)
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

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

taking any other drug. Take this product two 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 caplets in a 24-hour period unless directed by a doctor

Stop use and ask a doctor if

OTC - STOP USE SECTION

you fail to have a bowel movement after use or have rectal bleeding. These could be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSAGE 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 each dose of this product with a full glass of water (8oz.) 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 over2 caplets, 1 to 4 times per day
children under 12 years of ageask a doctor

Other information

OTHER SAFETY INFORMATION

each caplet contains: calcium 125 mg

do not use if printed seal under cap is torn or missing store in a dry place at 15° – 30°C (59° – 86°F)
protect contents from moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

1-800-231-4670

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by Foundation Consumer Brands, LLC, owner of the registered trademark Fibercon®.

DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017
www.myleader.com 1-800-200-6313

©2025 CARDINAL HEALTH, LEADER, and LOGOs are trademarks of Cardinal Health. All other marks are the property of their respective owners.

WARNING: This product can expose you to chemicals including lead, which is known to the State of California to cause cancer and birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADER

NDC 70000-0067-1

Fiber Laxative + Calcium

Calcium Polycarbophil, 625 mg

Bulk-Forming Laxative

Fiber Therapy for Regularity

COMPARE TO FIBERCON® active ingredient*

250 Caplets

Leader labelLeader label

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0067-1Calcium Polycarbophil250 in 1 BOTTLETABLET, FILM COATED2506

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0067-1EA - Each70000-0067df485456-7dc5-4dce-9775-0f0478a0f77b12021-06-02

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
70000-006770000-0067-1

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
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
LIGHT MINERAL OILN6K5787QVPIACT
SODIUM LAURYL SULFATE368GB5141JIACT
MAGNESIUM STEARATE70097M6I30IACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
STEARIC ACID4ELV7Z65APIACT
TALC7SEV7J4R1UIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CROSPOVIDONE2S7830E561IACT
HYPROMELLOSES3NXW29V3WOIACT
CARAMELT9D99G2B1RIACT
CALCIUM POLYCARBOPHIL8F049NKY49ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52025-02-10full-release2026-06-01 00:54:50

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
Calcium PolycarbophilCALCIUM POLYCARBOPHILLEADER/ Cardinal Health 110, Inc.b4637e18-c65f-0e81-e053-2a95a90a22842025-11-06WarningsExact identifier
ndc (package): 70000-0067-1
ndc (product): 70000-0067
ndc11 (package): 70000006701
spl id: 42f2e803-8cbd-dd94-e063-6294a90a0cd0
spl set id: b4637e18-c65f-0e81-e053-2a95a90a2284

Reported adverse events (FAERS/openFDA)#

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