FDA.reportPublic FDA data

Calcium Polycarbophil 625 mg

Manufacturer
Reliable 1 Laboratories LLC
Effective date
2021-10-27
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:44:33

Label at a glance#

ProductCalcium Polycarbophil 625 mg
Active ingredientCALCIUM POLYCARBOPHIL
Label structure17 sections

Indications and uses

relieves occasional constipation generally produces bowel movement in 12 to 72 hours

Dosage and administration

take caplets with at least 8 ounces (a full glass) of water or other fluid. Taking this prodcut without enough liquid may cause choking. See choking warning. take dose up to 4 times daily do not take more than 8 caplets in 24 hours adults & children 12 years and over: 2 caplets children under 12 years: ask a doctor

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 polycarbophil 500 mg)

Purpose

OTC - PURPOSE SECTION

Bulk-Forming Laxative

Uses

INDICATIONS & USAGE SECTION

  • relieves occasional constipation
  • 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 cuase 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.

OTC - DO NOT USE SECTION

Do not use longer than one week

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • abdominal pain, nausea, or vomiting
  • noticed a sudden change in bowel habits that lasts over two weeks

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • you have rectal bleeding
  • you fail to have a bowel movement after using this prodcut

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.

Drug Facts continued on back of label

Directions

DOSAGE & ADMINISTRATION SECTION

  • take caplets with at least 8 ounces (a full glass) of water or other fluid. Taking this prodcut without enough liquid may cause choking. See choking warning.
  • take dose up to 4 times daily
  • do not take more than 8 caplets in 24 hours
  • adults & children 12 years and over: 2 caplets
  • children under 12 years: ask a doctor

Other information

SPL UNCLASSIFIED SECTION

  • each caplet contains: calcium 140 mg
  • store at 15°-30°C (59°-86°F)
  • do not refrigerate
  • protect from humidity

INACTIVE INGREDIENT SECTION

Inactive ingredients carob powder, croscarmellose sodium, HPMC, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide

OTC - QUESTIONS SECTION

Questions or comments? call 516-341-0666,

8:30 am - 4:30 pm ET, Monday-Friday

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

SPL UNCLASSIFIED SECTION

*Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark FIBERCON®.

Distributed by: Reliable 1 Laboratories LLC, Valley Stream, NY 11580

www.reliablel1labs.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69618-030-06

Calcium Polycarbophil 625mg

Bulk-Forming Laxative

90 Caplets

*Compare to Active Ingredient in FIBERCON®

Calcium Polycarbophil 625 mgCalcium Polycarbophil 625 mg

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69618-030-062023-01-30C16284748780-1f386c649-ca05-0266-e053-dadaa90a7c1aCalcium Polycarbophil 625 mg
69618-030-092023-01-30C16284748780-1f386c649-ca05-0266-e053-dadaa90a7c1aCalcium Polycarbophil 625 mg
69618-030-502023-01-30C16284748780-1f386c649-ca05-0266-e053-dadaa90a7c1aCalcium Polycarbophil 625 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69618-030-06Calcium Polycarbophil 625 mg60 in 1 BOTTLE, PLASTICTABLET603
69618-030-09Calcium Polycarbophil 625 mg90 in 1 BOTTLE, PLASTICTABLET903
69618-030-50Calcium Polycarbophil 625 mg500 in 1 BOTTLE, PLASTICTABLET5003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69618-030CALCIUM POLYCARBOPHIL 625 MG TABLET [RELIABLE 1 LABORATORIES LLC]3Legacy NDC, 3 package rows20211029_2fabd7ec-228f-1565-e054-00144ff88e88.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69618-030-06EA - Each69618-030d6d4537b-b5d9-464e-acf7-029310b661c312016-05-16
69618-030-09EA - Each69618-0301d9a6b9d-e9b3-4dbd-99c6-d3c8687664db12016-05-16
69618-030-50EA - Each69618-0308ff71781-b510-4303-b008-81f10fd83c1012016-05-16

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69618-03069618-030-06, 69618-030-09, 69618-030-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
CROSCARMELLOSE SODIUMM28OL1HH48IACT
MAGNESIUM STEARATE70097M6I30IACT
HYPROMELLOSES3NXW29V3WOIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
CAROB5MG5Z946UOIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
POLYETHYLENE GLYCOL 1000U076Q6Q621IACT
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
cf5ef1b5-a514-ae3b-e053-2995a90ae2f42fabd7ec-228f-1565-e054-00144ff88e882021-10-27WarningsExact identifier
spl id: cf5ef1b5-a514-ae3b-e053-2995a90ae2f4
spl set id: 2fabd7ec-228f-1565-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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